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Heart FailurePhase 3NCT03448406

This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.

A Phase 3 study testing Empagliflozin in people with Heart Failure, run by Boehringer Ingelheim at 108 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic heart failure (CHF) with preserved ejection fraction (LVEF > 40%). Secondary objectives are to assess Patient-Reported Outcome (PRO) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
315 participants
Where
108 sitesin 11 countries
Study dates
20 Mar 2018to 9 Oct 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Of full age of consent (according to local legislation, usually ≥ 18 years) at screening.
  • Male or female patients. Women of child bearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
  • Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial
  • Six minute walk test (6MWT) distance ≤350 m at screening and at baseline.
  • Patients with CHF diagnosed for at least 3 months before Visit 1, and currently in NYHA class II-IV
  • Chronic heart failure (CHF) with preserved Ejection fraction (EF) defined as left ventricle ejection fraction(LVEF) > 40 % as per echocardiography at Visit 1 per local reading and no prior measurement of LVEF ≤ 40% under stable conditions.
Show all 12Show fewer
  • Elevated N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/ml for patients without atrial fibrillation (AF), OR > 600 pg/ml for patients with AF, as analysed at the Central laboratory at Visit 1
  • Patients must have at least one of the following evidence of heart failure (HF):
  • Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1, OR
  • Documented Hospitalization for Heart Failure (HHF) within 12 months prior to Visit 1
  • Consistent with prevailing CV guidelines, if oral diuretics are prescribed to control symptoms, patients must be on an appropriate and stable dose of oral diuretics for at least 2 weeks prior to Visit 1 to control symptoms.
  • Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).

Who cannot join

  • Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or transient ischemic attack in past 90 days prior to Visit 1
  • Acute decompensated HF (exacerbation of CHF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
  • Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0168)
  • Type 1 Diabetes Mellitus (T1DM)
  • Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
  • Symptomatic hypotension or a systolic blood pressure (SBP) < 100 mmHg at Visit 1 or 2
Show all 24Show fewer
  • SBP ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2
  • Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 1 (Screening)
  • Unstable angina pectoris in past 30 days prior to Visit 1
  • Largest distance walked in 6 minutes (6MWTD) at baseline <100m.
  • Any presence of condition that precludes exercise testing such as:
  • claudication,
  • uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
  • significant musculoskeletal disease,
  • primary pulmonary hypertension,
  • severe obesity (body mass index ≥40.0 kg/m2),
  • orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
  • amputation with artificial limb without stable prosthesis function for the past 3 months
  • Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWT
  • Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
  • ICD implantation within 1 month prior to Visit 1 or planned during the course of the trial
  • Implanted cardiac resynchronisation therapy (CRT)
  • Treatment with i.v. iron therapy or erythropoietin (EPO) within 3 months prior to screening.
  • Further exclusion criteria applies

Trial locations and contacts

108 sites in 11 countries.

108 sites in 11 countries

United States43 sites

  • Albany Stratton VA Medical Center Albany, NY

    Albany, New York, 12208

  • Northwest Heart Clinical Research, LLC

    Arlington Heights, Illinois, 60005

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • DiscoveResearch, Inc.

    Beaumont, Texas, 77701

  • St Luke's Clinic - Idaho Cardiology Associates

    Boise, Idaho, 83712

  • Grace Research, LLC

    Bossier City, Louisiana, 71111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Columbia Heart Clinic

    Columbia, South Carolina, 29203

  • Western Connecticut Health Network

    Danbury, Connecticut, 06810

  • John D. Dingell VA Medical Center

    Detroit, Michigan, 48201

  • Med Research One

    Florissant, Missouri, 63031

  • Mary Washington Hospital Research Department

    Fredericksburg, Virginia, 22401

  • Clinical Investigation Specialists, Inc

    Gurnee, Illinois, 60031

  • Chicago Medical Research

    Hazel Crest, Illinois, 60429

  • Angiocardiac Care of Texas

    Houston, Texas, 77025

  • California Heart Specialists

    Huntington Beach, California, 92648

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38301

  • The DOCS

    Las Vegas, Nevada, 89113

  • Rama Research LLC

    Marion, Ohio, 43302

  • Infinite Clinical Research

    Miami, Florida, 33133

  • Advance Medical Research Center

    Miami, Florida, 33135

  • Bio1 Clinical Research

    Miami Beach, Florida, 33140

  • Mobile Heart Specialists, PC

    Mobile, Alabama, 36608

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • York Clinical Research, LLC

    Norfolk, Virginia, 23510

  • Pharmacology Research, LLC

    North Miami Beach, Florida, 33169

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211

  • Palm Beach Gardens Research Center, LLC

    Palm Beach Gardens, Florida, 33410

  • UNC REX Healthcare

    Raleigh, North Carolina, 27607

  • Black Hills Cardiovascular Research

    Rapid City, South Dakota, 57701

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina, 27804

  • East Coast Institute for Research, LLC

    Saint Augustine, Florida, 32086

  • The Center for Clinical Trials, Inc.

    Saraland, Alabama, 36571

  • Grace Research, LLC

    Shreveport, Louisiana, 71107

  • Cox Medical Center South

    Springfield, Missouri, 65807

  • Manshadi Heart Institute, Inc

    Stockton, California, 95204

  • Acacia Medical Research Institute,LLC

    Sugar Land, Texas, 77478

  • University of California Los Angeles

    Torrance, California, 90502

  • Georgia Arrhythmia Consultants and Research Institute

    Warner Robins, Georgia, 31093

  • Clinical Trials of America LA, LLC

    West Monroe, Louisiana, 71291

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Cozy Research LLC

    Zephyrhills, Florida, 33541

Other trials in United States

Germany13 sites

  • CIMS Studienzentrum Bamberg GmbH

    Bamberg, 96049

  • Klinische Forschung Berlin GbR

    Berlin, 10787

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Universitätsklinikum Köln (AöR)

    Cologne, 50937

  • Cardiologicum Dresden und Pirna

    Dresden, 01277

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt, 60596

  • Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Magdeburg AöR

    Magdeburg, 39120

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Poland9 sites

  • INTERCORE Medical Center

    Bydgoszcz, 85-605

  • 10.Military Clin.Hospital&Polyclinic

    Bydgoszcz, 85681

  • Leszek Bryniarski Specialized Medical Cabinet

    Krakow, 30-082

  • Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz

    Lodz, 91-425

  • Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard

    Lodz, 92-213

  • Provincial Specialist M. Kopernik Hospital

    Lodz, 93-513

  • Independent Public Healthcare, Dept. of Cardiology, Pulawy

    Puławy, 24100

  • Central Hospital of Medical Academy, Warsaw

    Warsaw, 02-097

  • 4. Military Clinical Hospital with Polyclinic SP ZOZ

    Wroclaw, 50 981

Other trials in Poland

Spain8 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital San Rafael

    Granada, 18001

  • Hospital de la Inmaculada Concepción

    Granada, 18004

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital La Princesa

    Madrid, 28006

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

Italy7 sites

  • Centro Cardiologico Monzino-IRCCS

    Milan, 20138

  • Asst Santi Paolo E Carlo

    Milan, 20142

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ospedale Regina Montis Regalis

    Mondovì (CN), 12084

  • Università Federico II

    Naples, 80131

  • Università degli studi di Palermo

    Palermo, 90133

  • IRCCS San Raffaele

    Roma, 00163

Other trials in Italy

Portugal7 sites

  • CHLO, EPE - Hospital de Santa Cruz

    Carnaxide, 2795

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3041-801

  • Centro Hosp. de Leiria-Pombal

    Leiria, 2410-197

  • CHLC, EPE - Hospital de Santa Marta

    Lisbon, 1169-024

  • CHLO, EPE - Hospital S. Francisco Xavier

    Lisbon, 1449-005

  • CHULN, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

  • Centro Hospitalar Universitário São João,EPE

    Porto, 4200-319

Other trials in Portugal

Greece6 sites

  • General Hospital of Athens Konstantopoulio-Agia Olga

    Athens, 14233

  • General Hospital of Athens "G. Gennimatas"

    Athens, 15669

  • General Hospital of Chalkida

    Chalcis, 34100

  • University General Hospital of Heraklion

    Herakleion, Crete, 71110

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45500

  • University Hospital of Thessaloniki AHEPA

    Thessaloniki, 54636

Other trials in Greece

Canada4 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • KMH Cardiology Centres Inc.

    Mississauga, Ontario, L5K 2L3

  • Toronto Heart Centre

    Toronto, Ontario, M4P 1E4

  • Sameh Fikry Medicine Professional Corporation

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Norway4 sites

  • Sykehuset Østfold Kalnes

    Grålum, N-1714

  • Oslo Universitetssykehus HF, Rikshospitalet

    Oslo, N-0372

  • Helse Stavanger, Stavanger Universitetssykehus

    Stavanger, N-4011

  • St. Olavs Hospital, Universitetssykehuset i Trondheim

    Trondheim, N-7030

Other trials in Norway

Sweden4 sites

  • Sahlgrenska US, Göteborg

    Gothenburg, 413 45

  • Sahlgrenska Universitetssjukhuset, Östra

    Gothenburg, 416 85

  • Skånes universitetssjukhus, Lund

    Lund, 221 85

  • Akardo Med Site

    Stockholm, 11446

Other trials in Sweden

Australia3 sites

  • University of the Sunshine Coast

    Birtinya, Queensland, 4575

  • Peninsular Health CV Research Unit

    Frankston, Victoria, 3199

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

Other trials in Australia

About this study

Official title: A Phase III Randomised, Double-blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure With Preserved Ejection Fraction (HFpEF) (EMPERIAL - Preserved)

The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic heart failure (CHF) with preserved ejection fraction (LVEF > 40%).

Secondary objectives are to assess Patient-Reported Outcome (PRO)

Conditions
Heart Failure
Being tested
Empagliflozin, Placebo
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Also called JARDIANCE, JARDIANZ, GIBTULIO

    Film-coated tablet

  • PlaceboDrug

    Film-coated tablet

Study groups in NCT03448406
Study groupRoleWhat they receive
EmpagliflozinExperimentalNot described
Receives: Drug: Empagliflozin
PlaceboActive comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 12 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes in Standardised Conditions (6MWTD)

    Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions (6MWTD). If repeated 6-minutes walk test (6MWT) measurements were available for the same day, the longest distance was used for analysis. Change from baseline was defined as the distance walked in 6 minutes at Week 12 minus the baseline value.

    Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 12 but did not perform the 6MWT, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above.

    Measured: At baseline and at Week 12

Secondary outcomes (9)

  1. Change From Baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS)

    Change from baseline in KCCQ-TSS was defined as the endpoint value at week 12 minus the last available measurement before start of treatment with randomised study medication. The KCCQ is 23 item self-administered questionnaire and comprises 7 domains: physical limitation, symptom frequency, symptom burden, symptom stability, social limitation, self-efficacy and quality of life. Additionally 3 summary scores exist: TSS, clinical summary score, and overall summary score. The scores of the KCCQ domains and summary scores range from 0 to 100, with higher score indicating better outcome. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.

    Measured: At baseline and at Week 12

  2. Change From Baseline to Week 12 in Chronic Heart Failure Questionnaire Self- Administered Standardized Format (CHQ-SAS) Dyspnea Score

    Change from baseline in CHQ-SAS was defined as the endpoint value at week 12 minus the last available endpoint value before start of treatment with randomised study medication. The CHQ-SAS evaluates 3 domains: dyspnoea, fatigue, and emotional function. Scores of the domains range from 1 to 7, with higher score indicating better quality of life. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.

    Measured: At baseline and at Week 12

  3. Change From Baseline to Week 6 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes

    Change from baseline to week 6 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at Week 6 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication.

    If a participant was present at the visit at Week 6 but did not perform the 6-Minuted Walking Test, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 6, an imputed value was used.

    Measured: At baseline and at Week 6

  4. Change From Baseline in Clinical Congestion Score at Week 12

    Change from baseline to week 12 in Clinical Congestion score is defined as the score-value at week 12 minus the score-value at baseline. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. The Clinical Congestion Score (summary score) is based on 3 items: orthopnoea, jugular venous distention (JVD) and oedema. Each item was assessed through a 4-measure questionnaire, which was further converted to a standardised 4-point scale ranging from 0 to 3, with 0 indicating no or fewer symptoms and 3 indicating continous or more symptoms. If at least 2 of the 3 items are not missing, the summary score is calculated as: (average over items JVD, orthopnea and oedema actually answered)*3. The summary score ranges from 0 to 9, with lower value indicating better health, and higher value indicating worse health. Mean is adjusted mean.

    Measured: At baseline and at Week 12

  5. Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12

    Change from baseline to week 12 in PGI-S of Heart Failure Symptoms. The Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the Patient to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.

    Measured: At baseline and at Week 12

  6. Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12

    Change from baseline to week 12 in Patient Global Impression of Severity (PGI-S) of dyspnoea. The PGI-S of Dyspnoea is a 1-item questionnaire designed to assess the participant´s impression of symptom severity, specifically dyspnoea. The PGI-S item asks the participant to choose one response that best describes how his/her dyspnoea is now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.

    Measured: At baseline and at Week 12

  7. Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12

    The Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of change in heart failure symptoms, specifically: shortness of breath, fatigue, and swelling. The PGI-C asks the patient to choose one Response that best describes the overall change (if any) in his/her heart failure symptoms, specifically: shortness of breath, fatigue, and swelling since he/she started taking the study medication on a 7- category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).

    Measured: Week 12

  8. Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12

    The PGI-C in Dyspnoea is a 1-item questionnaire designed to assess the patient's Impression of change in dyspnoea. The PGI-C asks the patient to choose one response that best describes the change (if any) in his/her shortness of breath when performing usual activities since he/she started taking the study medication on a 7-category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).

    Measured: Week 12

  9. Relative Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NTproBNP) at Week 12

    Relative change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NTproBNP). Relative change from baseline is expressed as ratio of week 12 to baseline. Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. Mean is adjusted mean.

    Measured: Within 3 weeks prior to treatment start and at Week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start20 Mar 2018
  3. Primary completion4 Oct 2019
  4. Study completion9 Oct 2019

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448406
Sponsor's protocol ID
1245-0167
Other IDs
2017-004072-59, 2017
Status last verified
Nov 2020
First submitted
22 Feb 2018
Last updated
8 Dec 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Anker SD, Ponikowski P, Wanner C, Pfarr E, Hauske S, Peil B, Salsali A, Ritter I, Koitka-Weber A, Brueckmann M, Lindenfeld J, Abraham WT; EMPERIAL Investigators and National Coordinators. Kidney Function After Initiation and Discontinuation of Empagliflozin in Patients With Heart Failure With and Without Type 2 Diabetes: Insights From the EMPERIAL Trials. Circulation. 2021 Oct 12;144(15):1265-1267. doi: 10.1161/CIRCULATIONAHA.121.054669. Epub 2021 Aug 16. No abstract available.

    PubMed 34397263

  • Abraham WT, Ponikowski P, Brueckmann M, Zeller C, Macesic H, Peil B, Brun M, Ustyugova A, Jamal W, Salsali A, Lindenfeld J, Anker SD; EMPERIAL Investigators and National Coordinators. Rationale and design of the EMPERIAL-Preserved and EMPERIAL-Reduced trials of empagliflozin in patients with chronic heart failure. Eur J Heart Fail. 2019 Jul;21(7):932-942. doi: 10.1002/ejhf.1486. Epub 2019 Jun 19.

    PubMed 31218819

  • Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.

    PubMed 31081589

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin in people with Heart Failure, run by Boehringer Ingelheim at 108 sites in 11 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 12 inclusion and 24 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Germany, Poland, Spain, Italy and 6 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. 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 8 Dec 2020). 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?

Change From Baseline to Week 12 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes in Standardised Conditions (6MWTD) (time frame: At baseline and at Week 12). 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 NCT03448406, which also lists 3 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 8 Dec 2020.

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