Heart FailurePhase 3FINEARTS-HFNCT04435626
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
A Phase 3 study testing Finerenone (BAY94-8862) in people with Heart Failure, run by Bayer at 661 sites in 37 countries.
Trial summary
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Finerenone (BAY94-8862)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,016 participants
- Where
- 661 sitesin 37 countries
- Study dates
- 14 Sep 2020to 14 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant (male or female) must be aged 40 years and older.
- Diagnosis of heart failure with New York Heart Association(NYHA) class II-IV, ambulatory or hospitalized primarily for heart failure.
- On diuretic treatment for at least 30 days prior to randomization.
- Documented left ventricular ejection fraction (LVEF) of ≥40% measured by any modality within the last 12 months.
- Structural heart abnormalities based on any local imaging measurement within the last 12 months, defined by at least one of the following findings: left atrial diameter (LAD) ≥3.8cm, left atrial area (LAA) ≥20cm2, left atrial volume index (LAVI) >30 mL/m2, left ventricular mass index (LVMI) ≥115 g/m2 (♂)/ 95 g/m2 (♀), septal thickness or posterior wall thickness ≥1.1 cm
- n-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥300 pg/mL (BNP ≥100 pg/mL) in sinus rhythm and patient does not have an ongoing diagnosis of paroxysmal atrial fibrillation or NT-proBNP ≥900 pg/mL (BNP ≥300 pg/mL) in atrial fibrillation (or if atrial fibrillation status is unknown or if patient has an ongoing diagnosis of paroxysmal atrial fibrillation) for participants obtained at the following time:
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- Within 90 days prior to randomization if patient had been hospitalized for heart failure (HF) requiring initiation or change in HF therapy or if patient had an urgent visit for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization OR
- Within 30 days prior to randomization if patient has not been hospitalized for HF nor had an urgent HF visit within the past 90 days.
- Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and baseline and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.
Who cannot join
- Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m² at either screening or randomization visit.
- Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.
- Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to randomization
- Myocardial infarction or any event which could have reduced the ejection fraction within 90 days prior to randomization
- Coronary artery bypass graft surgery in the 90 days prior to randomization
- Percutaneous coronary intervention in the 30 days prior to randomization
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- Stroke or transient ischemic cerebral attack within 90 days prior to randomization
- Probable alternative cause of participants' HF symptoms that in the opinion of the investigator primarily accounts for patient's dyspnea such as significant pulmonary disease, anemia or obesity. Specifically, patients with the below are excluded: Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy, History of primary pulmonary arterial hypertension, Hemoglobin <10 g/dl, Valvular heart disease considered by the investigator to be clinically significant, Body Mass Index (BMI) >50 kg/m2 at screening
- Systolic blood pressure(SBP) ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at least 2-minute apart, at screening or at randomization.
- Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin) or moderate or potent CYP3A4 inducers, that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period.
Trial locations and contacts
661 sites in 37 countries.
661 sites in 37 countries
United States107 sites
VA Eastern Colorado Health Care System
Aurora, Colorado, 80045
Ascension Seton Heart Specialty Care and Transplant Center
Austin, Texas, 78705
Johns Hopkins Hospital - Cardiology
Baltimore, Maryland, 21287
Suburban Hospital - Cardiology
Bethesda, Maryland, 20814
WestSide Medical
Beverly Hills, California, 90211
Cardiology, PC
Birmingham, Alabama, 35211
Cardiovascular & Vein Center of Florida | Bradenton, FL
Bradenton, Florida, 34209
Nova Clinical Research - Blake Medical Center
Bradenton, Florida, 34209
Advanced Heart Care, LLC | Bridgewater, NJ
Bridgewater, New Jersey, 08807
Kernodle Clinic West
Burlington, North Carolina, 27215
Capital Area Research | Camp Hill, PA
Camp Hill, Pennsylvania, 17011
University of North Carolina
Chapel Hill, North Carolina, 27514
Advocate Illinois Masonic Medical Center - Cardiology
Chicago, Illinois, 60657
Colorado Springs Cardiology - Woodmen Medical Plaza
Colorado Springs, Colorado, 80923
Cardiovascular Specialists of Central Maryland, PA
Columbia, Maryland, 21044
Harry S Truman Memorial Veterans Hospital - Cardiology
Columbia, Missouri, 65201
Centricity Research at Talbotton
Columbus, Georgia, 31904
Cardiovascular Associates Research, LLC
Covington, Louisiana, 70433
Texas Health & Vascular Specialists - Dallas
Dallas, Texas, 75231
Southwest Family Medicine Associates | Dallas, TX
Dallas, Texas, 75235
Cardiology Associates Research Company
Daytona Beach, Florida, 32117
Henry Ford Hospital - OB/GYN
Detroit, Michigan, 48202
Advocate Good Samaritan Hospital - Cardiology
Downers Grove, Illinois, 60515
Doylestown Health Cardiology - DCA
Doylestown, Pennsylvania, 18901
Midwest Cardiovascular Research and Education Foundation | Elkhart, IN
Elkhart, Indiana, 46514
Inova Cardiology- Fairfax
Fairfax, Virginia, 22031
Eastern Shore Research Institute, LLC | Fairhope, AL
Fairhope, Alabama, 36532
Virginia Heart
Falls Church, Virginia, 22042
AA Medical Research Center | Flint, MI
Flint, Michigan, 48504
Texas Health Family Care - W Vickery Blvd
Fort Worth, Texas, 76107
North Florida Foundation for Research and Education - Clinical Trial Center
Gainesville, Florida, 32608
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
The Stern Cardiovascular Foundation - Germantown, TN
Germantown, Tennessee, 38138
CHI Health Clinic Heart Institute - Grand Island
Grand Island, Nebraska, 68803
Heart Clinic of Hammond
Hammond, Louisiana, 70403
Houston Heart & Vascular Associates
Humble, Texas, 77338
CA Heart and Vein Specialists
Huntington Beach, California, 92648
Baptist Heart -Cardiology - DCT Dept
Jackson, Mississippi, 39202
University Hospital - UMMC - Nephrology
Jackson, Mississippi, 39216
Apex Research Foundation, LLC. | Jackson, TN
Jackson, Tennessee, 38301
Logan Health Research
Kalispell, Montana, 59901
Clinical Research Consultants
Kansas City, Missouri, 64111
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
South Texas Cardiovascular Consultants, PLLC / Kerrville, TX
Kerrville, Texas, 78028
Kettering Health Network | Research Institute
Kettering, Ohio, 45429
Trident Cardiology Associates, PA
Ladson, South Carolina, 29456
Carolina Heart Specialists | Lancaster, SC
Lancaster, South Carolina, 29720
Virginia Heart - Leesburg
Leesburg, Virginia, 20176
Advocate Condell Medical Center
Libertyville, Illinois, 60048
CHI Health Nebraska Heart
Lincoln, Nebraska, 68526
NJ Heart | Linden, NJ
Linden, New Jersey, 07036
Heart Clinic Arkansas
Little Rock, Arkansas, 72205
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120
William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, 53705
Garden State Heart Care
Manalapan, New Jersey, 07726
M Health Fairview Heart Clinic - Maplewood
Maplewood, Minnesota, 55109
Rama Research LLC | Marion, OH
Marion, Ohio, 43302-6774
North Dallas Research Associates
McKinney, Texas, 75069
Lt. Col. Luke Weathers, Jr. VA Medical Center - Cardiology
Memphis, Tennessee, 38105
LifeSpring Research Foundation, LLC
Miami, Florida, 33130
Aurora Saint Luke's Medical Center - Cardiology
Milwaukee, Wisconsin, 53215
M Health Fairview Heart Clinic - Fulton
Minneapolis, Minnesota, 55455
Mobile Heart Specialists - Providence
Mobile, Alabama, 36608
Edward Hospital - Main Campus - Cardiology
Naperville, Illinois, 60540
Southwest Florida Research | Naples, FL
Naples, Florida, 34102-8143
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135
UCI Medical Center - Neurology
Orange, California, 92868
Baptist Health Paducah - Cardiology
Paducah, Kentucky, 42003
Carle Health Methodist Hospital - Cardiology
Peoria, Illinois, 61603
ClinRx Research, LLC
Plano, Texas, 75024
Nuvance Health - The Heart Center
Poughkeepsie, New York, 12601
Cardiovascular Research of Knoxville
Powell, Tennessee, 37849
Monument Health Clinical Research
Rapid City, South Dakota, 57701
Reid Physicians Associates - Cardiology Department
Richmond, Indiana, 47374
Division of Cardiovascular Research at Peconic Bay Medical Center
Riverhead, New York, 11901
Laurelton Heart Specialists
Rosedale, New York, 11422
Sutter Medical Center - Cardiology
Sacramento, California, 95816
East Coast Institute for Research | St. Augustine, FL
Saint Augustine, Florida, 32086
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
Salem VA Medical Center - Cardiology
Salem, Virginia, 24153
University of Utah Clinical Neurosciences Center
Salt Lake City, Utah, 84312
South Texas Cardiovascular Consultants - San Antonio
San Antonio, Texas, 78201
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212
NorthBay Clinical Research, LLC | Santa Rosa, CA
Santa Rosa, California, 95405
Saratoga Clinical Research, LLC
Saratoga Springs, New York, 12866
MaineHealth Cardiology - Scarborough
Scarborough, Maine, 04039
Sanford USD Medical Center - Cardiology
Sioux Falls, South Dakota, 57105
Louisiana Heart Center - Slidell
Slidell, Louisiana, 70458
Mercy Hospital Springfield - Cardiology
Springfield, Missouri, 65804
Cardiac Care & Vascular Medicine
The Bronx, New York, 10469
Northwest Houston Clinical Research - Tomball
Tomball, Texas, 77375
The Lundquist Institute - Gynecology
Torrance, California, 90502
Atlanta Heart Specialists - Tucker
Tucker, Georgia, 30084
University of Arizona Clinical and Translational Sciences Research Center
Tucson, Arizona, 85724
Northwell Health Physician Partners Cardiology at Valley Stream
Valley Stream, New York, 11580
Blue Coast Research Center, LLC
Vista, California, 92081
Kent Hospital
Warwick, Rhode Island, 02886
Cardiology Partners Clinical Research Institute | Wellington Office
Wellington, Florida, 33449
Interventional Cardio Medical- DCT Department
West Hills, California, 91307
Interventional Cardiology Medical Group | West Hills, CA
West Hills, California, 91307
Kansas Nephrology Research Institute
Wichita, Kansas, 67214
Selma Medical Associates
Winchester, Virginia, 22601
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Mercy Health - St. Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
Southern Clinical Research, LLC
Zachary, Louisiana, 70791
Japan47 sites
Nishiarai Heart Central Clinic
Adachi-ku, Tokyo, 123-0845
Ageo Central General Hospital
Ageo, Saitama, 362-8588
Japan Red Cross Society Azumino Hospital
Azumino, Nagano, 399-8292
Fukuoka University Nishijin Hospital
Fukuoka, 814-8522
Funabashi Municipal Medical Center
Funabashi, Chiba, 273-8588
Gifu Prefectural General Medical Center
Gifu, 500-8717
Minamino Cardiovascular Hospital
Hachiōji, Tokyo, 192-0918
Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
Hakusan, Ishikawa-ken, 924-8588
National Hospital Organization Hamada Medical Center
Hamada, Shimane, 697-8511
Hyogo Prefectural HarimaHimeji General Medical Center
Himeji, Hyōgo, 670-8560
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Yamaguchi, 740-8510
National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
Kanazawa, Ishikawa-ken, 920-8650
Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510
Kawaguchi Cardiovascular and Respiratory Hospital
Kawaguchi, Saitama, 333-0842
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-0042
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, 805-8508
National Hospital Organization Kobe Medical Center
Kobe, Hyōgo, 654-0155
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008
Kumamoto University Hospital
Kumamoto, 860-8556
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902
Miyazaki Medical Association Hospital
Miyazaki, 880-2102
Iwate Prefectural Central Hospital
Morioka, Iwate, 020-0066
R.I.A.C Naha City Hospital
Naha, Okinawa, 902-8511
Shinrakuen Hospital
Niigata, 950-2087
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502
Oita Prefectural Hospital
Ōita, 870-8511
The Sakakibara Heart Institute of Okayama
Okayama, 700-0804
Onga Nakama Medical Association Onga Hospital
Onga-gun, Fukuoka, 811-4342
Osaka Police Hospital | Clinical Research and Trial Center
Osaka, 543-0035
Osaka General Medical Center
Osaka, 558-8558
Social Corporation Keigakukai Minamiosaka Hospital
Osaka, 559-0012
Toho University Omori Medical Center
Ōta-ku, Tokyo, 143-8541
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, 252-5188
Saitama Sekishinkai Hospital
Sayama, Saitama, 350-1305
JCHO Shimonoseki Medical Center
Shimonoseki, Yamaguchi, 750-0061
Shobara Red Cross Hospital
Shōbara, Hiroshima, 727-0013
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557
Higashi Takarazuka Satoh Hospital
Takarazuka, Hyōgo, 665-0873
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1045
JA Toride Medical Center
Toride, Ibaraki, 302-0022
Toyama University Hospital
Toyama, 930-0194
Mitoyo General Hospital | Kagawa, Japan
Toyohama-Cho,Kanonji-City, Kagawa-ken, 769-1695
TOYOTA Memorial Hospital
Toyota, Aichi-ken, 471-8513
National Hospital Organization Shinshu Ueda Medical Center
Ueda, Nagano, 386-8610
Seiyu Memorial Hospital
Wakayama, 649-6335
Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
Yonago, Tottori, 683-8605
China45 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
Beijing Tsinghua Changgung Hospital
Beijing, 102218
Jilin Province People's Hospital
Changchun, Jilin, 130021
The First Hospital of Jilin University
Changchun, Jilin, 130061
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Changsha Central Hospital
Changsha, Hunan, 410004
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
Chengdu, Sichuan, 610072
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163311
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, 510120
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Hainan Provincial People's Hospital
Haikou, Hainan, 570311
1st Affiliated Hospital of College Medicine, Zhejiang Univ.
Hangzhou, Zhejiang, 310003
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, 223300
Jinan Central Hospital
Jinan, Shandong, 250013
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002
The Second Affiliated Hospital of Nanjing Medical university
Nanjing, Jiangsu, 210000
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211103
Panjin Liaohe Oilfield Gem Flower Hospital
Panjin, Liaoning, 124010
Hainan Third People's Hospital (Province Nongken Sanya Hopt)
Sanya, Hainan, 572000
Shanghai Tongji Hospital of Tongji University
Shanghai, 200065
Shanghai East Hospital Affiated to Tongji University
Shanghai, 200100
The First Hospital of Hebei Medical Univesity
Shijiazhuang, Hebei, 050000
1st Affiliated hospital of Soochow University
Suzhou, Jiangsu, 215000
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012
Tianjin People's Hospital
Tianjin, 300000
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi Sheng, 710061
Xinxiang Central Hospital
Xinxiang, Henan, 453000
Yinchuan No.1 People's Hospital
Yinchuan, Ningxia, 750001
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Russia28 sites
SBHI of Sverdlovsk Region Aramil City Hospital
Aramil, 624003
First City Clinical Hospital n.a. E.E. Volosevich
Arkhangelsk, 163001
Altai Regional Cardiological Dispensary
Barnaul, 656055
SBEI "Chita State Medical Academy"
Chita, 672000
Izhevsk City Clinical Hospital #9
Izhevsk, 426063
Kazan Federal University
Kazan', 420043
Clinical Diagnostic Center
Kazan', 420101
Sci-Res. Institute of Complex Cardiovascular Disorders
Kemerovo, 650002
Center of cardiology and neurology
Kirov, 610014
Research center of therapy and prophylactic medicine
Moscow, 101990
City Clinical Hospital #29 n.a. N.E. Bauman - Clinical-Diagnostic dept
Moscow, 111020
City clinical hospital n.a. V.V. Vinogradov
Moscow, 117292
Moscow State University n.a. M.V. Lomonosov
Moscow, 119192
Russian Clinical and Research Center of Gerontology
Moscow, 129226
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087
Omsk Region "Clinical Health Unit No. 9"
Omsk, 644018
Penza Regional Clinical Hospital n.a. N.N. Burdenko
Penza, 440026
Perm Regional Hospital for War Veterans
Perm, 614097
Rostov-on-Don Emergency Clinical Hospital
Rostov-on-Don, 344068
SBI of the Ryazan region "Regional clinical hospital"
Ryazan, 390039
Scien. Res. Inst. of Emergency Care n.a. I.I. Dzhanelidze
Saint Petersburg, 192242
St. Petersburg Clinical Hospital of RAS
Saint Petersburg, 194017
LLC Astarta
Saint Petersburg, 199226
Samara Regional Clinical Cardiology Dispensary n.a. Polyakov
Samara, 443070
Clinical Hospital #3 n.a. S.R. Mirotvortsev
Saratov, 410054
Scientific Research Institute of Cardiology
Tomsk, 634012
Tomsk Regional Clinical Hospital
Tomsk, 634063
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, 620102
Czechia23 sites
Fakultní nemocnice Brno - Interní kardiologická klinika
Brno, South Moravian, 625 00
Kardiologie MUDr. Libor Nechvatal s.r.o.
Brno, 602 00
Kardiologicka ambulance Brno s.r.o.
Brno, 612 00
Kardiologicka ambulance
Český Krumlov, 381 01
Kardio Chlumec s.r.o.- Kardiologicka ambulance
Chlumec nad Cidlinou, 503 51
Poliklinika Dolní Brežany
Dolní Břežany, 252 41
Fakultní Nemocnice Hradec Kralové
Hradec Králové, 500 05
Kromerizska nemocnice a.s.
Kroměříž, 767 01
LUNACOR, Centrum pro choroby srdce a cev
Kroměříž, 767 01
Krajska Nemocnice Liberec
Liberec, 460 63
KardioBusak s.r.o.
Louny, 440 01
Fakultni nemocnice Plzen
Pilsen, 301 00
Kardiologicka a interni ambulance
Písek, 39701
Polabska zdravotni, s.r.o.
Poděbrady, 290 01
Všeobecná fakultní nemocnice v Praze - II. interní klinika - klinika kardiologie a angiologie
Prague, 12808
Institut Klinicke a Experimentalni Mediciny
Prague, 140 21
Fakultní nemocnice v Motole
Prague, 150 06
Ustredni vojenska nemocnice Praha
Prague, 169 02
Affidea Praha s.r.o - Kardiologie
Praha 11 - Chodov, 148 00
Kardio s.r.o.
Třebíč, 67401
Nemocnice Podlesi
Třinec, 73961
Angiocor s.r.o.
Zlín, 760 01
Nemocnice Znojmo
Znojmo, 669 02
Spain23 sites
Instituto Medico Quirurgico San Rafael S.A. - Cardiologia
A Coruña, 15006
Hospital del Mar
Barcelona, 08003
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, 08035
Hospital Universitari de Bellvitge (HUB)
Barcelona, 8908
Hospital Santa María del Puerto - Medicina Interna
El Puerto de Santa María, Cádiz, 11500
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
Ferrol, A Coruña, 15405
Hospital Universitario Virgen De Las Nieves - Cardiologia
Granada, 18014
Hospital Universitario de Gran Canaria Dr. Negrin - Cardiologia
Las Palmas de Gran Canaria, Las Palmas, 35010
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida - Medicina Interna
Lleida, 25198
Hospital Universitario La Zarzuela - Cardiologia
Madrid, 28023
Hospital Ramón y Cajal | Medicina Interna
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen De La Victoria - Cardiologia
Málaga, Málaga, 29010
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Vega Baja De Orihuela - Medicina Interna
San Bartolomé, Alicante, 03314
Hospital Virgen del Camino - Medicina Interna
Sanlúcar de Barrameda, Cádiz, 11540
Hospital Universitario Virgen de Valme - Medicina Interna
Seville, 41014
Hospital Alta Resolucion de Utrera - Cardiologia
Utrera, Sevilla, 41710
Hospital Clinico Universitario de Valencia (CHUV)
Valencia, 46010
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Y Politecnico La Fe - Cardiologia
Valencia, 46026
Hospital de Manises - Medicina Interna
Valencia, 46940
Hospital Virgen De Las Montanas - Medicina Interna
Villamartín, Cádiz, 11650
Italy22 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 1
Bergamo, Lombardy, 24127
Azienda Unita Sanitaria Locale Di Bologna_Ospedale Maggiore Pizzardi - Medicina A
Bologna, Emilia-Romagna, 40133
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Medicina Interna Cardiovascolare
Bologna, Emilia-Romagna, 40138
Azienda Socio-Sanitaria Territoriale Del Garda
Brescia, Lombardy, 25085
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Cardiologia
Brescia, Lombardy, 25123
Azienda Ospedaliero Universitaria Renato Dulbecco
Catanzaro, Calabria, 88100
Azienda Unita' Sanitaria Locale Toscana Sud Est
Cortona, Tuscany, 52040
Azienda Socio Sanitaria Territoriale Di Cremona
Cremona, Lombardy, 26100
University Hospital Of Ferrara
Ferrara, Emilia-Romagna, 44124
Centro Cardiologico Monzino S.p.A.
Milan, Lombardy, 20138
ASST di Monza
Monza Brianza, Lombardy, 20832
Azienda Ospedaliera Universitaria Federico II Di Napoli - DAI Emergenze Cardiovascolari, Medicina Clinica e Dell'Invecchiamento
Naples, Campania, 80131
A.O.U. Maggiore della Carità
Novara, Piedmont, 28100
IRCCS Fondazione Policlinico San Matteo
Pavia, Lombardy, 27100
Istituti Clinici Scientifici Maugeri S.p.A
Pavia, Lombardy, 27100
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Cardiologia
Perugia, Umbria, 06129
Azienda Unita Sanitaria Locale Di Piacenza
Piacenza, Emilia-Romagna, 29121
Humanitas Mirasole S.p.A. - Cardiologia Clinica e Interventistica
Rozzano, Lombardy, 20089
Azienda Ospedaliera Universitaria Senese
Siena, Tuscany, 53100
ASST Sette Laghi_Ospedale Galmarini - Medicina Generale
Tradate, Lombardy, 21049
Azienda Ospedaliera Universitaria Integrata Verona_Borgo Trento - Cardiologia
Verona, Veneto, 37126
Azienda Socio Sanitaria Territoriale Della Brianza _Ospedale di Vimercate - Medicina Interna
Vimercate, Lombardy, 20871
Canada21 sites
Brampton Clinical Trials
Brampton, Ontario, L6Z 4N5
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6
Vizel Cardiac Research
Cambridge, Ontario, N1R 7R1
Dalhousie University - Queen Elizabeth II (QEII) Health Sciences Centre - Halifax Infirmary (HI)
Halifax, Nova Scotia, B3H 3A7
Centre intégré de santé et de services sociaux de Laval, Hôp
Laval, Quebec, H7M 3L9
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario, N6A 5A5
KMH Cardiology Clinics Inc.
Mississauga, Ontario, L5K 2L3
G.A. Research Associates, Ltd.
Moncton, New Brunswick, E1G 1A7
Clinique Sante Cardio MC
Montreal, Quebec, H1T 3Y7
Centre Hospitalier de l'Université de Montréal-CHUM
Montreal, Quebec, H2X 0C1
Montreal General Hospital
Montreal, Quebec, H4A 3J1
Fraser Clinical Trials, Inc.
New Westminster, British Columbia, V3L 3W4
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7
Oakville Cardiovascular Research
Oakville, Ontario, L6K 3W7
Office of Dr. James Cha, MD
Oshawa, Ontario, L1J 2K1
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
Corcare
Scarborough Village, Ontario, M1B 5N1
Medicus MFC Inc.
Toronto, Ontario, M4P 1E4
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Women's College Hospital
Toronto, Ontario, M5S 1B2
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Ukraine21 sites
MNPE "Cherkasy Regional Cardiology Center" - Department of Coronary Heart Disease and Non-Coronary Myocardial Diseases
Cherkasy, 18009
Clinical Emergency Hospital" of Dnipro City Council - Department of Cardiology
Dnipro, 49006
National Institute of Therapy L.T.Maloyi, Department of Chronic Non-Communicable Diseases
Kharkiv, 61039
Regional Dispensary of Radiation Protection of Population - Cardiology Department
Kharkiv, 61166
MNPE "City Clinical Hospital No. 8" of the Kharkiv City Council, Cardiology Department No. 2
Kharkiv, 61176
Municipal Non-Profit Enterprise "Kyiv City Clinical Hospital No. 1" - Department of Cardiology
Kiev, 02 091
Medical Center "Medbud" - Treatment and prophylactic department
Kyiv, 03037
National Scientific Center Institute of Cardiology named M.D. Strazhesko of the NAMSU - Department of Cardiac Arrhythmias
Kyiv, 03151
National Scientific Center Institute of Cardiology named M.D. Strazhesko of the NAMSU - Department of Heart Failure
Kyiv, 03151
National Scientific Center Institute of Cardiology named M.D. Strazhesko of the NAMSU - Department of Hypertension
Kyiv, 03151
LLC "Medical Center "Consilium Medical", Clinical and Consultative Departmen 1
Kyiv, 04050
Railway Clinical Hospital #2
Kyiv, 3049
Lviv Regional Clinical Treatment and Diagnostic Cardiology Center, consulting polyclinic
Lviv, 79015
Poltava Regional Clinical Hospital. M.V. Sklifosovsky, Cardiology Department
Poltava, 36011
Zakarpatsky Oblasnyi Kardiologichnyi Dyspanser, Infarction department
Uzhhorod, 880000
Vinnytsia Regional Clinical Hospital, Clinical Cardiology Department
Vinnytsia, 21018
Vinnytsia City Clinical Hospital #1, Therapeutic Department
Vinnytsia, 21029
Zaporizhia Municipal Clinical Hospital No.10, Cardiology Department
Zaporizhzhya, 69001
Zaporizhzhya City Emergency Care Hospital, Cardiology Department
Zaporizhzhya, 69005
Regional Medical Center for Cardiovascular Diseases-Heart failure department
Zaporizhzhya, 69005
Hospital No. 1 of the Zhytomyr City - consulting and treatment department Scientific and research center
Zhytomyr, 10002
Bulgaria20 sites
Ambulatory facility for specialized outpatient medical care
Burgas, 8000
MHAT Haskovo
Haskovo, 6304
MHAT Zdrave
Pazardzhik, 4400
Multiprofile Hospital for Active Treatment Sveti Georgi OOD, Pernik - Department of Cardiology
Pernik, 2300
Medical Center Medconsult Pleven
Pleven, 5800
Medical centre Hipokrat - N EOOD
Plovdiv, 4000
Multiprofile Hospital for Active Treatment Medline | Cardiology Department
Plovdiv, 4000
Multiprofile Hospital for Active Treatment Sveta Karidad | Cardiology Department
Plovdiv, 4004
Multiprofile Hospital for Active Treatment | Shumen - First Department of Internal Medicine
Shumen, 9700
MHAT Hadzhi Dimitar
Sliven, 8800
Second Medical Center Sofia EOOD
Sofia, 1202
Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
Sofia, 1233
NMTH Tzar Boris III
Sofia, 1233
Multiprofile Hospital for Active Treatment 'National Cardiology Hospital' EAD, Sofia
Sofia, 1309
Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases Department
Sofia, 1404
Medical Center Hera
Sofia, 1510
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, 1527
MHAT Trakia
Stara Zagora, 6000
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department
Veliko Tarnovo, 5000
Multiprofile Hospital for Active Treatment Sveti Panteleymon Yambol | Cardiology Department
Yambol, 8600
Argentina19 sites
Instituto Cardiovascular de Buenos Aires | Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., C1428ART
Hospital Militar Central "CIR. MY. C. Argerich"
Buenos Aires, Ciudad Auton. de Buenos Aires, 1426
Centro de Especialidades Medicas (CEMEDIC)
Buenos Aires, Ciudad Auton. de Buenos Aires, C1440CFD
Investigaciones Medicas IMOBA S.R.L.
Buenos Aires, C1056ABH
CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina
CABA, Ciudad Auton. de Buenos Aires, C1018DES
Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina
Ciudad Autónoma de Buenos Aire, Buenos Aires, C1056ABI
Clínica Privada del Prado
Córdoba, 5000
Instituto Médico DAMIC- Fundación Rusculleda
Córdoba, 5003
Clínica Coronel Suarez
Coronel Suárez, Buenos Aires, B7540GHD
Instituto de Cardiologia de Corrientes Juana F. Cabral | Corrientes, Argentina
Corrientes, 3400
Hospital Italiano de La Plata | Clinical Research Department
La Plata, Buenos Aires, B1900
Centro de Investigaciones Medicas Lanus | Buenos Aires, Argentina
Lanus, Buenos Aires, B1824
Sanatorio Modelo Quilmes
Quilmes, Buenos Aires, 1878
Grupo Orono | Instituto Cardiovascular de Rosario - Insuficiencia Cardiaca y Trasplante Department
Rosario, Santa Fe Province, 2000
Consultorios Integrados Rosario | Instituto Medico de la Fundacion de Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Corporación Médica de General San Martín
San Martín, Buenos Aires, 1650
Instituto de Cardiologia | Tucuman, AR
San Miguel de Tucumán, Tucumán Province, 4000
Centro de Investigaciones Clinicas del Litoral | Santa Fe, Argentina
Santa Fe, S3000FWO
Instituto De Investigaciones Clinicas Zarate | Zarate, Argentina
Zárate, Buenos Aires, B2800DGH
Brazil19 sites
Centro de Pesquisa Clinica do Coração | Aracaju, Brasil
Aracaju, Sergipe, 49055-530
Hospital Felício Rocho
Belo Horizonte, São Paulo, 30110-130
MK Consultoria Médico Científica Ltda/Angiocor Blumenau
Blumenau, Santa Catarina, 89020-430
Hospital do Coração do Brasil
Brasília, Federal District, 70390-700
Campinas Clinical Research Institute (IPECC) | Campinas, Brazil
Campinas, São Paulo, 13060-080
Fundação Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, 95070-560
Quanta Diagnostico Por Imagem | Research and Innovation Department
Curitiba, Paraná, 80045-170
Hospital das Clinicas da Universidade Federal de Goias | Centro de Pesquisa em Cardiologia
Goiânia, Goiás, 74605-020
Instituto do Coração de Marilia | Marilia, Brasil
Marília, São Paulo, 17515-000
Eurolatino Pesquisas Medicas | Uberlandia, MG
Minas Gerais, 38400-368
Sociedade Hospitalar Angelina Caron | Departamento de Ensino e Pesquisa
Paraná, Paraná, 83430-000
Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research Center
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90850-170
FZ Pesquisa e Servicos em Cardiologia | Porto Alegre, Brazil
Porto Alegre, Rio Grande do Sul, 91350-280
Centro Avançado de Pesquisa para Diagnóstico - CAPED
Ribeirão Preto, São Paulo, 14026-020
Santa Casa de Misericórdia da Bahia
Salvador, Estado de Bahia, 50040-410
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
São Paulo, São Paulo, 13034-685
IMC - Instituto de Moléstias Cardiovasculares Tatui
Tatuí, São Paulo, 18270-170
Santa Casa de Misericórdia de Votuporanga
Votuporanga, São Paulo, 15500-003
Colombia19 sites
Cardiomet Cequin Sas
Armenia, Quindío Department, 630004
Clínica de la Costa SAS
Baranquilla, Atlántico, 080020
Corazón IPS S.A.S.
Barranquilla, Atlántico, 080020
IPS Centro Cientifico Asistencial S.A.S
Barranquilla, Atlántico, 080020
Fundacio del Caribe para la Investigacio Bio-Medica (BIOS)
Barranquilla, 080001
Caja de Compensación Familiar CAFAM
Bogotá, Bogota D.C., 111061
Hospital Universitario Mayor-MÉDERI
Bogotá, Bogota D.C., 111411
Fundación Cardioinfantil
Bogotá, 110131
Hospital Universitario de San Ignacio
Bogotá, 110231
Hospital Universitario Clínica San Rafael
Bogotá, 110621
Instituto del Corazón de Bucaramanga
Bucaramanga, Santander Department, 680002
Clínica Imbanaco S.A.S
Cali, Valle del Cauca Department, 760042
Mediservis del Tolima IPS S.A.S
Ibague, Tolima Department, 730008
Hospital Alma Mater de Antioquia
Medellín, Antioquia, 050010
Hospital General de Medellin
Medellín, Antioquia, 050015
Rodrigo Botero S.A.S
Medellín, Antioquia, 050021
Hospital San Vicente Fundación
Medellín, 050010
Clinica Cardio VID
Medellín, 050034
Sociedad Médica Rionegro SOMER S.A.
Rionegro, Antioquia, 054040
Slovakia19 sites
Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
Banská Bystrica, 974 01
ALIAN s.r.o.
Bardejov, 085 01
Nemocnica svateho Michala, a.s.
Bratislava, 81108
Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto
Bratislava, 813 69
Narodny ustav srdcovych a cievnych chorob, a.s
Bratislava, 833 48
Centrum interv. neuroradiologie a endovaskularnej liecby
Bratislava, 84103
Kardiosanus | Bratislava, Slovakia
Bratislava, 84107
Nemocnica s poliklinikou Brezno, n.o.
Brezno, 977 01
Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho
Dolný Kubín, 026 14
JG-COR s.r.o.
Košice, 040 01
Medical Group Kosice s.r.o. | Kosice, Slovakia
Košice, 04001
KARDIO-ANGIO s.r.o.
Levice, 93401
KardioMed s.r.o.
Lučenec, 984 01
MEDI M&M, s.r.o.
Moldava nad Bodvou, 045 01
Kardiocentrum Nitra | Cardiology Clinic - Outpatient Department
Nitra, 949 01
KARDIOMED NZ s.r.o.
Nové Zámky, 940 01
MEDISPOL s.r.o.
Prešov, 08001
COR, s.r.o
Šahy, 936 01
Medivasa s.r.o.
Žilina, 1001
Hungary18 sites
Cardiomobile Egeszsegugyi Szolgaltato Kft.
Balatonfüred, 8230
Budai Irgalmasrendi Korhaz
Budapest, 1023
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1024
University of Semmelweis/ Semmelweis Egyetem
Budapest, 1083
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
Budapest, 1134
Budapesti Uzsoki Utcai Kórház
Budapest, 1145
Bugat Pal Korhaz
Gyöngyös, 3200
Pharma4Trial Kft.
Gyöngyös, 3200
Csongrad-Csanad Varmegyei Egeszsegugyi Ellato Kozpont Hodmezovasarhelyi Tagintezmeny
Hódmezővásárhely, 6800
Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526
Nagykanizsai Kanizsai Dorottya Korhaz
Nagykanizsa, 8800
Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
Nyíregyháza, 4400
Coromed Smo Kft
Pécs, 7623
Da Vinci Maganklinika
Pécs, 7635
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, 6720
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat
Székesfehérvár, 8000
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100
Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz
Szentes, 6600
Poland15 sites
KLIMED Marek Klimkiewicz
Bialystok, 15-704
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej
Gdynia, 81-519
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
Grodzisk Mazowiecki, 05 825
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice, 40-156
Unicardia Specjalistyczne Centrum Leczenia Ch.Serca i Naczyn
Krakow, 31-271
IMEDICA Centrum Medyczne
Lublin, 20-068
NZOZ "Twoja Przychodnia" Sp. z o.o.
Lublin, 20-857
Zechowicz Medeusz-Plus Lekarska Spolka Partnerska
Olsztyn, 10-010
Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
Oświęcim, 32-600
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 61-848
Szpital Specjalistyczny SPZOZ
Puławy, 24-100
NZOZ Pro-Cordis Sopockie Centrum Badan Kardiologicznych
Sopot, 81-717
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-500
Gessek Jacek Prywatny Gabinet Lekarski
Torun, 87-100
Romania15 sites
Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
Baia Mare, 430031
Emergency County Hospital, Braila
Brăila, 810318
S.C Thera Card S.R.L
Brasov, 500102
Emergency Institute for Cardiovascular Diseases
Bucharest, 22322
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 50098
Spitalul Clinic de Urgenta "Sf. Pantelimon"
Bucharest, TBC
Spitalul Clinic Judetean De Urgenta Craiova
Craiova Dolj, 200642
Sf. Ap. Andrei Emergency Clinical County Hospital Galati
Galati, 800578
S.C. CARDIOMED S.R.L. Iasi
Iași, 700732
S.C. Sal Med SRL
Piteşti, TBC
CMI. Dr. Podoleanu Cristian
Târgu Mureş, Mureș County, TBC
S.C. Cardio Med S.R.L.
Târgu Mureş, 540124
Spitalul Clinic Municipal de Urgenta "Timisoara"
Timișoara, Timiș County, 300040
Municipal Clinical Emergency Hospital of Timisoara
Timișoara, Timiș County, 300254
Institutul De Boli Cardiovasculare Timisoara
Timișoara, 300310
Israel14 sites
Assuta Ashdod Public Hospital (R.A)
Ashdod, 7747629
Barzilai Ashkelon University Medical Center | Cardiology Department
Ashkelon, 7830604
Rambam Health Corporation
Haifa, 3109601
Bnai Zion Medical Center | Cardiology Department
Haifa, 3339419
Lady Davis Carmel Medical Center
Haifa, 3436212
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001
Meir Medical Center
Kfar Saba, 4428164
Health Corporation of Galilee Medical Center
Nahariya, 2210001
Chaim Sheba Medical Center
Ramat Gan, 5262000
Kaplan Medical Center
Rehovot, 7610001
Health Corporation of the Ziv Medical Center (R.A.)
Safed, 1311001
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
Poria Medical Center | Cardiovascular Department
Tiberias, 1528001
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, 7030000
United Kingdom14 sites
Wansbeck General Hospital
Ashington, Northumberland, NE63 9JJ
North Hampshire Hospital
Basingstoke, Hampshire, RG24 9NA
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR
Royal Bournemouth General Hospital
Bournemouth, Dorset, BH7 7DW
University Hospitals Sussex NHS Foundation Trust | St Richard's Hospital - Cardiology services
Chichester, West Sussex, PO19 6SE
Hull University Teaching Hospitals NHS Trust | Castle Hill Hospital - Cardiology
Cottingham, HU16 5JQ
Dudley Group NHS Foundation Trust ¦Russells Hall Hopsital - Oncology
Dudley, West Midlands, DY1 2HQ
Queen Elizabeth University Hospital
Glasgow, Glasgow City, G51 4TF
NHS Greater Glasgow and Clyde | Glasgow Royal Infirmary |Glasgow Research Facility - Cardiology
Glasgow, G31 2ER
University Hospitals Leicester
Leicester, Leicestershire, LE3 9QP
Manchester Royal Infirmary
Manchester, M13 9WL
Poole Hospital NHS Trust
Poole, Dorset, BH15 2JB
Lister Hospital
Stevenage, Hertfordshire, SG1 4AB
Great Western Hospital
Swindon, SN3 6BB
Netherlands13 sites
Ziekenhuis Groep Twente
Almelo, 7609 PP
Deventer Ziekenhuis
Deventer, 7416 SE
Slingeland Ziekenhuis
Doetinchem, 7009 BL
Ziekenhuis Gelderse Vallei
Ede, 6716 RP
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Ziekenhuis St. Jansdal
Harderwijk, 3844 DG
Tergooiziekenhuizen-Blaricum
Hilversum, 1212 VG
Maastricht UMC
Maastricht, 6229 HX
Isala Meppel
Meppel, 7943 KA
Antonius Ziekenhuis Sneek
Sneek, 8601 ZR
ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)
Tilburg, 5042 AD
Maxima Medisch Centrum, locatie Veldhoven
Veldhoven, 5504 DB
Turkey (Türkiye)13 sites
Afyonkarahisar Saglik Bilimleri Universitesi
Afyonkarahisar, 3218
Saglik Bilimleri Universitesi Antalya EA Hastanesi
Antalya, 7100
Trakya Univ. Tip Fak.
Edirne, 22030
Eskisehir Osmangazi Universitesi Tip Fakultesi
Eskişehir, 26480
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, 34098
Istanbul Universitesi Kardiyoloji Enstitusu
Istanbul, 34304
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
Istanbul, TBC
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35340
Erciyes Universitesi Tip Fakultesi
Kayseri, 38039
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
Konya, 42080
Kutahya Saglik Bilimleri Uni. Evliya Celebi Egitim ve Arasti
Kütahya, 43040
Mersin Universitesi Tip Fakultesi
Mersin, 33079
Greece12 sites
University General Hospital of Alexandroupoli
Alexandroupoli, 68100
General Hosp of Athens "Korgialenio-Benakeio" RCH
Ampelokipi - Athens, 11526
HIPPOKRATION General Hospital of Athens
Athens, 115 27
G. GENNIMATAS General State Hospital of Athens
Athens, 11527
ALEXANDRA General Hospital of Athens
Athens, 11528
University General Hospital of Athens "ATTIKON"
Chaïdári, 12462
University General Hospital of Heraklion - Department of Paediatrics
Heraklion, 711 10
KAT General Hospital of Athens
Kifissia, Attica, 14561
University General Hospital of Larissa
Larissa, 41110
Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
Nea Ionia, 14233
University General Hospital of Patras
Pátrai, 26504
Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit'
Thessaloniki, 54642
Portugal12 sites
Hospital Prof. Dr. Fernando Fonseca
Amadora, 2720-276
BlueClinical | Centro Hospitalar Baixo Vouga - Unidade Aveiro - Gabinete de Ensaios Clinicos
Aveiro, 3810-501
Unidade Local de Saúde de Coimbra, E.P.E. - Cardiology Department - Research Unit
Coimbra, 3004-561
Centro Hospitalar Universitario Cova de Beira | Clinical Research Department
Covilha, Castelo Branco District, 6200-251
ULSG - Unidade Local de Saude da Guarda
Guarda, 6300-659
Hospital da Senhora da Oliveira | Clinical Research Department
Guimaraes, Braga, Braga District, 4835-044
Centro Hospitalar de Leiria | Santo Andre Hospital - Research Center
Leiria, 2410-197
Unidade Local De Saúde De Lisboa Ocidental E.P.E.
Lisbon, 1449-005
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
Lisbon, 1500-650
Hospital Pedro Hispano | Clinical Research Center
Matosinhos Municipality, Porto District, 4464-513
Centro Hospitalar Universitario do Porto
Porto, 4099-001
Luz Saude | Hospital da Luz Setubal - Clinical Research Department
Setúbal, Setúbal District, 2900-722
Australia10 sites
The Wesley Hospital
Auchenflower, Queensland, 4066
Flinders Medical Centre
Bedford Park, South Australia, 5042
Advara HeartCare Ringwood
Bundoora, Victoria, 3083
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
The Prince Charles Hospital
Chermside, Queensland, 4032
Gosford Hospital
Gosford, New South Wales, 2250
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Advara HeartCare Leabrook
Leabrook, South Australia, 5068
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Gold Coast University Hospital
Southport, Queensland, 4215
South Korea10 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggido, 14068
Dong-A University Hospital
Busan, 49201
Pusan National University Hospital
Busan, 49241
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Chung Nam National University Hospital
Daejeon, 35015
Chonnam National University Hospital
Gwangju, 501-757
Bundang Cha Hospital
Seongnam-si, Gyeonggido, 13496
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080
Yonsei University Wonju Christian Hospital
Wŏnju, Gang''weondo, 26426
Austria9 sites
Krankenhaus St. Josef Braunau | Innere Medizin I
Braunau am Inn, Upper Austria, 5280
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, 6807
Medizinische Universität Graz
Graz, Styria, 8036
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, 9020
Uniklinikum Salzburg - Landeskrankenhaus
Salzburg, 5020
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, 3100
Universitätsklinikum AKH Wien
Vienna, 1090
Imed19-privat
Vienna, 1190
Klinik Floridsdorf - Krankenhaus Nord
Vienna, 1210
Denmark9 sites
Aarhus Universitetshospital - Børn og Unge
Århus N, 8200
Sydvestjysk Sygehus Esbjerg | Kardiologisk Forskningsenhed
Esbjerg, 6700
Capital Region | Gentofte Hospital - Cardiology Research
Hellerup, 2900
Capital Region | Herlev Hospital - Heart Disease Department
Herlev, 2730
Region Midtjylland | Regionshospitalet Godstrup - Clinic for Heart Research
Herning, 7400
Region Sjælland | Holbaek Sygehus - Cardiology department
Holbæk, 4300
Hvidovre Hospital - Hjertesygdomme
Hvidovre, 2650
Regionshospitalet Randers - Medicinsk afdeling
Randers, 8930
Odense University Hospital | Svendborg Hospital - Cardiovascular Research Unit
Svendborg, 5700
Mexico9 sites
Hospital General de Acapulco
Acapulco de Juárez, Guerrero, 39910
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230
Hospital de Jesús
Alcaldía Cuauhtemoc, Mexico City, 6090
Fundación de Atencion e Investigacion Medica Lindavista SC
Alcaldia Gustavo A. Madero, Mexico City, 7300
Centro de Investigacion y Atencion Integral Durango S.C.
Durango, 34080
Consultorio de Medicina Especializada del Sector Privado
Guadalajara, Jalisco, 44657
Centro de Estudios Clinicos de Queretaro S. C. (CECLIQ)
Querétaro City, Querétaro, 76000
Centro de Investigación Médica Dr. Alberto Bazzoni SA de CV
Torreón, Coahuila, 27000
Hospital Ángeles de Xalapa
Xalapa, Veracruz, 91193
Taiwan8 sites
Changhua Christian Hospital
Changhua, 50006
Mackay Memorial Hospital - Hsinchu Branch
Hsinchu, 300
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807377
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 100
Taipei Medical University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital at Linkou
Taoyuan, 33305
Germany7 sites
Städt. Kliniken Bielefeld gGmbH
Bielefeld, North Rhine-Westphalia, 33604
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, 20246
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625
Sana-Klinikum Remscheid GmbH
Remscheid, North Rhine-Westphalia, 42859
Herzklinik Ulm GbR
Ulm, Baden-Wurttemberg, 89077
Forschungszentrum Ruhr | KliFoCenter GmbH
Witten, North Rhine-Westphalia, 58455
Klinikum der Universität Würzburg
Würzburg, Bavaria, 97080
Latvia7 sites
Daugavpils Regional Hospital
Daugavpils, LV-5417
Jelgava Outpatient Clinic
Jelgava, LV-3001
Liepaja Regional Hospital
Liepāja, LV-3414
1st Riga Clinical Hospital
Riga, LV-1001
P. Stradins Clinical University Hospital
Riga, LV-1002
GK Neiroklinika
Riga, LV-1024
Gita Rancane - cardiology private practice
Ventspils, LV-3601
Lithuania7 sites
UAB "Klinikiniai sprendimai" Alytus
Alytus, LT-63200
LUHS Kauno Hospital (Laisves ave.)
Kaunas, LT-44320
LUHS Kauno Hospital (Josvainiu str.)
Kaunas, LT-47144
Saules family medicine center
Kaunas, LT-49449
Klaipedos Jurininku Ligonine
Klaipėda, LT-92288
Siauliai Republican hospital
Šiauliai, 76231
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661
Malaysia7 sites
Gleneagles Penang Medical Center
George Town, 10050
Institute Jantung Negara
Kuala Lumpur, 50400
University Malaya Medical Centre
Kuala Lumpur, 59100
Hospital Sultan Idris Shah Serdang (Hospital Serdang)
Kuala Selangor, 43000
Hospital Raja Permaisuri Bainun
Perak, 30450
Hospital Pulau Pinang
Pulau Pinang, 10450
Sarawak Heart Centre
Sarawak, 94300
New Zealand7 sites
University of Auckland
Auckland, 1023
Christchurch Heart Institute
Christchurch, 8140
Dunedin Hospital
Dunedin, 9016
P3 Research Ltd Tauranga
Hawkes Bay, 4130
Hutt Hospital
Lower Hutt, 5010
Nelson Hospital
Nelson, 7042
P3 Research
Tauranga, 3110
India5 sites
KEM hospital
Berlin, Maharashtra, 10365
The Madras Medical Mission (MMM)
Chennai, Tamil Nadu, 600037
Max Super Speciality Hospital, Saket
New Delhi, National Capital Territory of Delhi, 110017
Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, 110029
Deenanath Mangeshkar Hospital
Pune, Maharashtra, 411004
Hong Kong4 sites
Prince of Wales Hospital
Hong Kong, N.T, MISSING
Princess Margaret Hospital
Hong Kong, MISSING
Queen Mary Hospital
Hong Kong, MISSING
Queen Elizabeth Hospital Hong Kong
Hong Kong
Finland3 sites
HUS Jorvin sairaala
Espoo, 2740
Tampereen yliopistollinen sairaala
Tampere, 33520
Turun yliopistollinen keskussairaala
Turku, 20520
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity and Mortality in Participants With Heart Failure (NYHA II-IV) and Left Ventricular Ejection Fraction ≥ 40% (LVEF ≥ 40%)
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
- Conditions
- Heart Failure
- Being tested
- Finerenone (BAY94-8862), Placebo
- Keywords
- Heart Failure with Preserved Ejection Fraction,, Mineralocorticoid receptor antagonist (MRA)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY94-8862)Drug
For participants with an eGFR ≤60 mL/min/1.73 m^2: Starting dose is 10 mg OD and maximum dose 20 mg OD.
For participants with an eGFR >60 mL/min/1.73 m^2: Starting dose is 20 mg OD and maximum dose 40 mg OD. Finerenone is administered orally as immediate release tablets.
PlaceboOther
Placebo tablets matching BAY94-8862 are administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1_BAY94-8862 | Experimental | Adult patients receive BAY94-8862 Receives: Drug: Finerenone (BAY94-8862) |
| Arm 2_Placebo | Placebo comparator | Adult patients receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events
Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.
Measured: From randomization up until the end of study, with an average study duration of 32 months
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events
Number of participants with composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.
Measured: From randomization up until the end of study, with an average study duration of 32 months
Secondary outcomes (6)
Occurrence of Total (First and Recurrent) Heart Failure Events
Number of total (first and recurrent) heart failure events.
Measured: From randomization up until the end of study, with an average study duration of 32 months
Occurrence of Total (First and Recurrent) Heart Failure Events
Number of participants with total (first and recurrent) heart failure events.
Measured: From randomization up until the end of study, with an average study duration of 32 months
Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) is ranged from 0 to 100. A higher score (closer to 100) reflects fewer symptoms, indicating better heart failure symptom status.
For the change from baseline the combined and averaged result across the entire time frame is reported.
Measured: From baseline to Month 6, 9 and 12
Proportion of Participants Who Showed Improvement in NHYA Class
The New York Heart Association (NYHA) Functional Classification is a simple scale that classifies patients with heart failure based on the severity of their symptoms and how those symptoms affect their physical activity, which ranges from Class I to Class IV, a lower class number is indicative of a better condition. A patient was considered as having improved in NYHA class, if the NYHA class at Month 12 is at least one category improved compared to the baseline visit.
Measured: from baseline to Month 12
First Occurrence of Renal Composite Events
Number of participants with renal composite events encompassing the components sustained decrease in eGFR ≥50% relative to baseline over at least 4 weeks, sustained eGFR decline to <15 mL/min/1.73 m2 over at least 4 weeks, initiation of chronic dialysis and renal transplantation.
Measured: From randomization up to end of study visit, with an average study duration of 32 months
Occurence of All-cause Mortality (Full Analysis Set)
Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.
Measured: From randomization until end of study, with an average of 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start14 Sep 2020
- Primary completion15 May 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435626
- Sponsor's protocol ID
- 20103
- Other IDs
- 2020-000306-29
- Acronym
- FINEARTS-HF
- Status last verified
- Aug 2025
- First submitted
- 15 Jun 2020
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Bhatt AS, Chatur S, Claggett BL, Lay-Flurrie J, Viswanathan P, Vardeny O, Kosiborod MN, Sharma K, Solomon SD, Vaduganathan M. Gamified Behavioral Science Intervention to Enhance Trial Enrollment: An Embedded Study Within the FINEARTS-HF Trial. JACC Heart Fail. 2024 Nov;12(11):1939-1941. doi: 10.1016/j.jchf.2024.05.002. Epub 2024 May 11. No abstract available.
PubMed 38944793Jhund PS, Talebi A, Henderson AD, Claggett BL, Vaduganathan M, Desai AS, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Solomon SD, McMurray JJV. Mineralocorticoid receptor antagonists in heart failure: an individual patient level meta-analysis. Lancet. 2024 Sep 21;404(10458):1119-1131. doi: 10.1016/S0140-6736(24)01733-1. Epub 2024 Sep 1.
PubMed 39232490Kondo T, Henderson AD, Docherty KF, Jhund PS, Vaduganathan M, Solomon SD, McMurray JJV. Why Have We Not Been Able to Demonstrate Reduced Mortality in Patients With HFmrEF/HFpEF? J Am Coll Cardiol. 2024 Nov 26;84(22):2233-2240. doi: 10.1016/j.jacc.2024.08.033. Epub 2024 Sep 1.
PubMed 39217560Ostrominski JW, Aggarwal R, Claggett BL, Kulac IJ, Desai AS, Jhund PS, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Lay-Flurrie J, Viswanathan P, McMurray JJV, Solomon SD, Vaduganathan M. Generalizability of the Spectrum of Kidney Risk in the FINEARTS-HF Trial to U.S. Adults With Heart Failure. J Card Fail. 2024 Sep;30(9):1170-1174. doi: 10.1016/j.cardfail.2024.04.015. Epub 2024 May 11. No abstract available.
PubMed 38740173Ostrominski JW, Claggett BL, Miao ZM, Mc Causland FR, Anand IS, Desai AS, Jhund PS, Lam CSP, Pfeffer MA, Pitt B, Zannad F, Zile MR, Bomfim Wirtz A, Lay-Flurrie J, Viswanathan P, McMurray JJV, Solomon SD, Vaduganathan M. Cardiovascular-Kidney-Metabolic Overlap in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Trial-Level Analysis. J Am Coll Cardiol. 2024 Jul 9;84(2):223-228. doi: 10.1016/j.jacc.2024.05.005. Epub 2024 May 12. No abstract available.
PubMed 38744407Solomon SD, McMurray JJV, Vaduganathan M, Claggett B, Jhund PS, Desai AS, Henderson AD, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Abidin IZ, Alcocer-Gamba MA, Atherton JJ, Bauersachs J, Chang-Sheng M, Chiang CE, Chioncel O, Chopra V, Comin-Colet J, Filippatos G, Fonseca C, Gajos G, Goland S, Goncalvesova E, Kang S, Katova T, Kosiborod MN, Latkovskis G, Lee AP, Linssen GCM, Llamas-Esperon G, Mareev V, Martinez FA, Melenovsky V, Merkely B, Nodari S, Petrie MC, Saldarriaga CI, Saraiva JFK, Sato N, Schou M, Sharma K, Troughton R, Udell JA, Ukkonen H, Vardeny O, Verma S, von Lewinski D, Voronkov L, Yilmaz MB, Zieroth S, Lay-Flurrie J, van Gameren I, Amarante F, Kolkhof P, Viswanathan P; FINEARTS-HF Committees and Investigators. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024 Oct 24;391(16):1475-1485. doi: 10.1056/NEJMoa2407107. Epub 2024 Sep 1.
PubMed 39225278Solomon SD, Ostrominski JW, Vaduganathan M, Claggett B, Jhund PS, Desai AS, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Abidin IZ, Alcocer-Gamba MA, Atherton JJ, Bauersachs J, Ma CS, Chiang CE, Chioncel O, Chopra V, Comin-Colet J, Filippatos G, Fonseca C, Gajos G, Goland S, Goncalvesova E, Kang SM, Katova T, Kosiborod MN, Latkovskis G, Lee AP, Linssen GCM, Llamas-Esperon G, Mareev V, Martinez FA, Melenovsky V, Merkely B, Nodari S, Petrie MC, Saldarriaga CI, Saraiva JFK, Sato N, Schou M, Sharma K, Troughton R, Udell JA, Ukkonen H, Vardeny O, Verma S, von Lewinski D, Voronkov LG, Yilmaz MB, Zieroth S, Lay-Flurrie J, van Gameren I, Amarante F, Viswanathan P, McMurray JJV. Baseline characteristics of patients with heart failure with mildly reduced or preserved ejection fraction: The FINEARTS-HF trial. Eur J Heart Fail. 2024 Jun;26(6):1334-1346. doi: 10.1002/ejhf.3266. Epub 2024 May 11.
PubMed 38733212Vaduganathan M, Claggett BL, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Desai AS, Jhund PS, Viswanathan P, Bomfim Wirtz A, Schloemer P, Lay-Flurrie J, McMurray JJV, Solomon SD. Finerenone in patients with heart failure with mildly reduced or preserved ejection fraction: Rationale and design of the FINEARTS-HF trial. Eur J Heart Fail. 2024 Jun;26(6):1324-1333. doi: 10.1002/ejhf.3253. Epub 2024 May 14.
PubMed 38742248Vaduganathan M, Filippatos G, Claggett BL, Desai AS, Jhund PS, Henderson A, Brinker M, Kolkhof P, Schloemer P, Lay-Flurrie J, Viswanathan P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD. Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes. Nat Med. 2024 Dec;30(12):3758-3764. doi: 10.1038/s41591-024-03264-4. Epub 2024 Sep 1.
PubMed 39218030Vaduganathan M, Neuen BL, McCausland F, Jhund PS, Docherty KF, McMurray JJV, Solomon SD. Why Has it Been Challenging to Modify Kidney Disease Progression in Patients With Heart Failure? J Am Coll Cardiol. 2024 Nov 26;84(22):2241-2245. doi: 10.1016/j.jacc.2024.08.034. Epub 2024 Sep 1. No abstract available.
PubMed 39217561Lu H, Claggett BL, Ostrominski JW, Pfeffer MA, Pitt B, Jhund PS, McMurray JJV, Solomon SD, Desai AS, Vaduganathan M. Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials. Eur J Heart Fail. 2026 Aug 30:xuag245. doi: 10.1093/ejhf/xuag245. Online ahead of print.
PubMed 42669134Chimura M, Pellicori P, Docherty K, Claggett BL, Campbell RT, Desai AS, Packer M, Jhund PS, Petrie MC, Rouleau JL, Teerlink JR, Vaduganathan M, van Veldhuisen DJ, Zannad F, Zile MR, Solomon SD, McMurray JJV. Low-Normal Hemoglobin Concentrations and Clinical Outcomes in Heart Failure. J Am Coll Cardiol. 2026 Aug 28:S0735-1097(26)07437-1. doi: 10.1016/j.jacc.2026.08.013. Online ahead of print.
PubMed 42663359Ono R, Docherty KF, Henderson AD, Claggett BL, Desai AS, Lam CSP, Senni M, Shah SJ, Schou M, Voors AA, Amarante F, Lay-Flurrie J, Glasauer A, Zannad F, Vaduganathan M, Jhund PS, Solomon SD, McMurray JJV. HFpEF-ABA Score and Finerenone in Patients With Heart Failure and Mildly Reduced or Preserved Ejection Fraction: Insights From the FINEARTS-HF Trial. JACC Heart Fail. 2026 Aug 27:103297. doi: 10.1016/j.jchf.2026.103297. Online ahead of print.
PubMed 42663335Boettger P, Sedighi J, Sohns C, Bauersachs J, Assmus B, Sossalla S. Cost-effectiveness of finerenone in heart failure with mildly reduced or preserved ejection fraction - Insights from FINEARTS-HF. Eur J Heart Fail. 2026 May 24:xuag167. doi: 10.1093/ejhf/xuag167. Online ahead of print.
PubMed 42178507Bains M, Butt JH, Ostrominski JW, Pabon Porras MA, Humphreys-Davies L. Treatment with finerenone in people with heart failure and mildly reduced or preserved ejection fraction: a plain language review. Future Cardiol. 2026 Apr;22(4):323-351. doi: 10.1080/14796678.2026.2650667. Epub 2026 Apr 28.
PubMed 42047456
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity and Mortality in Participants With Heart Failure (NYHA II-IV) and Left Ventricular Ejection Fraction ≥ 40% (LVEF ≥ 40%)
- ClinicalTrials.gov ID
- NCT04435626
- Acronym / sponsor ID
- FINEARTS-HF / 20103
- Conditions
- Heart Failure
- Keywords
- Heart Failure with Preserved Ejection Fraction,, Mineralocorticoid receptor antagonist (MRA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,016 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1_BAY94-8862 | Experimental | Drug: Finerenone (BAY94-8862)Adult patients receive BAY94-8862 |
| Arm 2_Placebo | Placebo comparator | Other: PlaceboAdult patients receive placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant (male or female) must be aged 40 years and older.
- Diagnosis of heart failure with New York Heart Association(NYHA) class II-IV, ambulatory or hospitalized primarily for heart failure.
- On diuretic treatment for at least 30 days prior to randomization.
- Documented left ventricular ejection fraction (LVEF) of ≥40% measured by any modality within the last 12 months.
- Structural heart abnormalities based on any local imaging measurement within the last 12 months, defined by at least one of the following findings: left atrial diameter (LAD) ≥3.8cm, left atrial area (LAA) ≥20cm2, left atrial volume index (LAVI) >30 mL/m2, left ventricular mass index (LVMI) ≥115 g/m2 (♂)/ 95 g/m2 (♀), septal thickness or posterior wall thickness ≥1.1 cm
Key exclusion criteria (10 listed)
- Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m² at either screening or randomization visit.
- Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.
- Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to randomization
- Myocardial infarction or any event which could have reduced the ejection fraction within 90 days prior to randomization
- Coronary artery bypass graft surgery in the 90 days prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone (BAY94-8862)For participants with an eGFR ≤60 mL/min/1.73 m^2: Starting dose is 10 mg OD and maximum dose 20 mg OD. For participants with an eGFR >60 mL/min/1.73 m^2: Starting dose is 20 mg OD and maximum dose 40 mg OD. Finerenone is administered orally as immediate release tablets. | Drug | Arm 1_BAY94-8862 |
| PlaceboPlacebo tablets matching BAY94-8862 are administered orally. | Other | Arm 2_Placebo |
Primary outcome
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events
Time frame: From randomization up until the end of study, with an average study duration of 32 months
Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events
Time frame: From randomization up until the end of study, with an average study duration of 32 months
Number of participants with composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.
6 secondary outcomes
Occurrence of Total (First and Recurrent) Heart Failure Events
Time frame: From randomization up until the end of study, with an average study duration of 32 months
Occurrence of Total (First and Recurrent) Heart Failure Events
Time frame: From randomization up until the end of study, with an average study duration of 32 months
Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: From baseline to Month 6, 9 and 12
Proportion of Participants Who Showed Improvement in NHYA Class
Time frame: from baseline to Month 12
First Occurrence of Renal Composite Events
Time frame: From randomization up to end of study visit, with an average study duration of 32 months
Occurence of All-cause Mortality (Full Analysis Set)
Time frame: From randomization until end of study, with an average of 32 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38944793Bhatt AS, Chatur S, Claggett BL, Lay-Flurrie J, Viswanathan P, Vardeny O, Kosiborod MN, Sharma K, Solomon SD, Vaduganathan M. Gamified Behavioral Science Intervention to Enhance Trial Enrollment: An Embedded Study Within the FINEARTS-HF Trial. JACC Heart Fail. 2024 Nov;12(11):1939-1941. doi: 10.1016/j.jchf.2024.05.002. Epub 2024 May 11. No abstract available.
- Results publication: PubMed 39232490Jhund PS, Talebi A, Henderson AD, Claggett BL, Vaduganathan M, Desai AS, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Solomon SD, McMurray JJV. Mineralocorticoid receptor antagonists in heart failure: an individual patient level meta-analysis. Lancet. 2024 Sep 21;404(10458):1119-1131. doi: 10.1016/S0140-6736(24)01733-1. Epub 2024 Sep 1.
- Results publication: PubMed 39217560Kondo T, Henderson AD, Docherty KF, Jhund PS, Vaduganathan M, Solomon SD, McMurray JJV. Why Have We Not Been Able to Demonstrate Reduced Mortality in Patients With HFmrEF/HFpEF? J Am Coll Cardiol. 2024 Nov 26;84(22):2233-2240. doi: 10.1016/j.jacc.2024.08.033. Epub 2024 Sep 1.
- Results publication: PubMed 38740173Ostrominski JW, Aggarwal R, Claggett BL, Kulac IJ, Desai AS, Jhund PS, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Lay-Flurrie J, Viswanathan P, McMurray JJV, Solomon SD, Vaduganathan M. Generalizability of the Spectrum of Kidney Risk in the FINEARTS-HF Trial to U.S. Adults With Heart Failure. J Card Fail. 2024 Sep;30(9):1170-1174. doi: 10.1016/j.cardfail.2024.04.015. Epub 2024 May 11. No abstract available.
- Results publication: PubMed 38744407Ostrominski JW, Claggett BL, Miao ZM, Mc Causland FR, Anand IS, Desai AS, Jhund PS, Lam CSP, Pfeffer MA, Pitt B, Zannad F, Zile MR, Bomfim Wirtz A, Lay-Flurrie J, Viswanathan P, McMurray JJV, Solomon SD, Vaduganathan M. Cardiovascular-Kidney-Metabolic Overlap in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Trial-Level Analysis. J Am Coll Cardiol. 2024 Jul 9;84(2):223-228. doi: 10.1016/j.jacc.2024.05.005. Epub 2024 May 12. No abstract available.
- Results publication: PubMed 39225278Solomon SD, McMurray JJV, Vaduganathan M, Claggett B, Jhund PS, Desai AS, Henderson AD, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Abidin IZ, Alcocer-Gamba MA, Atherton JJ, Bauersachs J, Chang-Sheng M, Chiang CE, Chioncel O, Chopra V, Comin-Colet J, Filippatos G, Fonseca C, Gajos G, Goland S, Goncalvesova E, Kang S, Katova T, Kosiborod MN, Latkovskis G, Lee AP, Linssen GCM, Llamas-Esperon G, Mareev V, Martinez FA, Melenovsky V, Merkely B, Nodari S, Petrie MC, Saldarriaga CI, Saraiva JFK, Sato N, Schou M, Sharma K, Troughton R, Udell JA, Ukkonen H, Vardeny O, Verma S, von Lewinski D, Voronkov L, Yilmaz MB, Zieroth S, Lay-Flurrie J, van Gameren I, Amarante F, Kolkhof P, Viswanathan P; FINEARTS-HF Committees and Investigators. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024 Oct 24;391(16):1475-1485. doi: 10.1056/NEJMoa2407107. Epub 2024 Sep 1.
- Results publication: PubMed 38733212Solomon SD, Ostrominski JW, Vaduganathan M, Claggett B, Jhund PS, Desai AS, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Abidin IZ, Alcocer-Gamba MA, Atherton JJ, Bauersachs J, Ma CS, Chiang CE, Chioncel O, Chopra V, Comin-Colet J, Filippatos G, Fonseca C, Gajos G, Goland S, Goncalvesova E, Kang SM, Katova T, Kosiborod MN, Latkovskis G, Lee AP, Linssen GCM, Llamas-Esperon G, Mareev V, Martinez FA, Melenovsky V, Merkely B, Nodari S, Petrie MC, Saldarriaga CI, Saraiva JFK, Sato N, Schou M, Sharma K, Troughton R, Udell JA, Ukkonen H, Vardeny O, Verma S, von Lewinski D, Voronkov LG, Yilmaz MB, Zieroth S, Lay-Flurrie J, van Gameren I, Amarante F, Viswanathan P, McMurray JJV. Baseline characteristics of patients with heart failure with mildly reduced or preserved ejection fraction: The FINEARTS-HF trial. Eur J Heart Fail. 2024 Jun;26(6):1334-1346. doi: 10.1002/ejhf.3266. Epub 2024 May 11.
- Results publication: PubMed 38742248Vaduganathan M, Claggett BL, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Desai AS, Jhund PS, Viswanathan P, Bomfim Wirtz A, Schloemer P, Lay-Flurrie J, McMurray JJV, Solomon SD. Finerenone in patients with heart failure with mildly reduced or preserved ejection fraction: Rationale and design of the FINEARTS-HF trial. Eur J Heart Fail. 2024 Jun;26(6):1324-1333. doi: 10.1002/ejhf.3253. Epub 2024 May 14.
- Results publication: PubMed 39218030Vaduganathan M, Filippatos G, Claggett BL, Desai AS, Jhund PS, Henderson A, Brinker M, Kolkhof P, Schloemer P, Lay-Flurrie J, Viswanathan P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD. Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes. Nat Med. 2024 Dec;30(12):3758-3764. doi: 10.1038/s41591-024-03264-4. Epub 2024 Sep 1.
- Results publication: PubMed 39217561Vaduganathan M, Neuen BL, McCausland F, Jhund PS, Docherty KF, McMurray JJV, Solomon SD. Why Has it Been Challenging to Modify Kidney Disease Progression in Patients With Heart Failure? J Am Coll Cardiol. 2024 Nov 26;84(22):2241-2245. doi: 10.1016/j.jacc.2024.08.034. Epub 2024 Sep 1. No abstract available.
- Derived from this study: PubMed 42669134Lu H, Claggett BL, Ostrominski JW, Pfeffer MA, Pitt B, Jhund PS, McMurray JJV, Solomon SD, Desai AS, Vaduganathan M. Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials. Eur J Heart Fail. 2026 Aug 30:xuag245. doi: 10.1093/ejhf/xuag245. Online ahead of print.
- Derived from this study: PubMed 42663359Chimura M, Pellicori P, Docherty K, Claggett BL, Campbell RT, Desai AS, Packer M, Jhund PS, Petrie MC, Rouleau JL, Teerlink JR, Vaduganathan M, van Veldhuisen DJ, Zannad F, Zile MR, Solomon SD, McMurray JJV. Low-Normal Hemoglobin Concentrations and Clinical Outcomes in Heart Failure. J Am Coll Cardiol. 2026 Aug 28:S0735-1097(26)07437-1. doi: 10.1016/j.jacc.2026.08.013. Online ahead of print.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
661 sites in 37 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Finerenone (BAY94-8862) in people with Heart Failure, run by Bayer at 661 sites in 37 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 661 sites in United States, Japan, China, Russia, Czechia and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events (time frame: From randomization up until the end of study, with an average study duration of 32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04435626, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.