AzTrials
AzTrials

Heart Failure With Preserved Ejection FractionPhase 3DELIVERNCT03619213

Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.

A Phase 3 study testing Dapagliflozin in people with Heart Failure With Preserved Ejection Fraction, run by AstraZeneca at 348 sites in 20 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

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control… Read more about this study

Who is it for?
Ages 40 to 130 years
What is being tested?
Dapagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,263 participants
Where
348 sitesin 20 countries
Study dates
27 Aug 2018to 27 Mar 2022
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 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed informed consent prior to any study specific procedures.
  • Male or female patients age ≥40 years.
  • Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
  • Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
  • Elevated NT-pro BNP levels.
  • Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.
  • Further details regarding inclusion criteria 4-6 may apply.

Who cannot join

  • Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
  • Type 1 diabetes mellitus (T1D).
  • eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
  • Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
  • Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
  • MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
Show all 11Show fewer
  • Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
  • Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
  • Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
  • Body mass index >50 kg/m2.
  • Further exclusion criteria may apply

Trial locations and contacts

348 sites in 20 countries.

348 sites in 20 countries

United States66 sites

  • Research Site

    Altoona, Pennsylvania, 16601

  • Research Site

    Anderson, Indiana, 46011

  • Research Site

    Atlanta, Georgia, 30303

  • Research Site

    Bay City, Michigan, 48708

  • Research Site

    Beaumont, Texas, 77701

  • Research Site

    Beverly Hills, California, 90211

  • Research Site

    Boston, Massachusetts, 02114

  • Research Site

    Boston, Massachusetts, 02115

  • Research Site

    Bridgewater, New Jersey, 08807

  • Research Site

    Buffalo, New York, 14215

  • Research Site

    Burlington, Vermont, 05401

  • Research Site

    Charleston, South Carolina, 29425

  • Research Site

    Charlotte, North Carolina, 28277

  • Research Site

    Chicago, Illinois, 60612

  • Research Site

    Chicago, Illinois, 60637

  • Research Site

    Clearwater, Florida, 33756

  • Research Site

    Doylestown, Pennsylvania, 18901

  • Research Site

    Fairhope, Alabama, 36532

  • Research Site

    Falls Church, Virginia, 22042

  • Research Site

    Flint, Michigan, 48504

  • Research Site

    Flint, Michigan, 48532

  • Research Site

    Great Falls, Montana, 59405

  • Research Site

    Greensboro, North Carolina, 27405

  • Research Site

    Gurnee, Illinois, 60031

  • Research Site

    Hammond, Louisiana, 70403

  • Research Site

    Houma, Louisiana, 70360

  • Research Site

    Humble, Texas, 77338

  • Research Site

    Jackson, Tennessee, 38301

  • Research Site

    Kansas City, Missouri, 64111

  • Research Site

    Kansas City, Missouri, 64128

  • Research Site

    Las Vegas, Nevada, 89106

  • Research Site

    Lebanon, New Hampshire, 03756

  • Research Site

    Leesburg, Virginia, 20176

  • Research Site

    Little Rock, Arkansas, 72204

  • Research Site

    Loma Linda, California, 92357

  • Research Site

    Los Angeles, California, 90073

  • Research Site

    Louisville, Kentucky, 40202

  • Research Site

    Madison, Wisconsin, 53705

  • Research Site

    Miami, Florida, 33155

  • Research Site

    Milwaukee, Wisconsin, 53295

  • Research Site

    Minneapolis, Minnesota, 55417

  • Research Site

    Mobile, Alabama, 36608

  • Research Site

    Monroe, Louisiana, 71201

  • Research Site

    Morgantown, West Virginia, 26506

  • Research Site

    Munster, Indiana, 46321

  • Research Site

    Naples, Florida, 34102

  • Research Site

    Nashville, Tennessee, 37212

  • Research Site

    New York, New York, 10001

  • Research Site

    New York, New York, 10021

  • Research Site

    New York, New York, 10029

  • Research Site

    Ocala, Florida, 34471

  • Research Site

    Oklahoma City, Oklahoma, 73134

  • Research Site

    Ormond Beach, Florida, 32174

  • Research Site

    Port Charlotte, Florida, 33952

  • Research Site

    Providence, Rhode Island, 02908

  • Research Site

    Rapid City, South Dakota, 57701

  • Research Site

    Rochester, Minnesota, 55905

  • Research Site

    Saint Augustine, Florida, 32086

  • Research Site

    Saint Paul, Minnesota, 55102

  • Research Site

    Sheffield, Alabama, 35660

  • Research Site

    Sherman, Texas, 75092

  • Research Site

    St Louis, Missouri, 63136

  • Research Site

    Stamford, Connecticut, 06905

  • Research Site

    Tucson, Arizona, 85724

  • Research Site

    Tullahoma, Tennessee, 37388

  • Research Site

    Wilmington, North Carolina, 28401

Other trials in United States

Japan43 sites

  • Research Site

    Adachi-ku, 123-0845

  • Research Site

    Asahi-shi, 289-2511

  • Research Site

    Azumino-shi, 399-8292

  • Research Site

    Beppu-shi, 874-0011

  • Research Site

    Chūōku, 103-0027

  • Research Site

    Fujisawa-shi, 251-0041

  • Research Site

    Fujisawa-shi, 251-8550

  • Research Site

    Funabashi-shi, 274-0065

  • Research Site

    Hachioji-shi, 192-0918

  • Research Site

    Hamada-shi, 697-8511

  • Research Site

    Hamamatsu, 430-0929

  • Research Site

    Higashiohmi-shi, 527-8505

  • Research Site

    Ichinomiya-shi, 494-0001

  • Research Site

    Iizuka-shi, 820-8505

  • Research Site

    Iwakuni-shi, 740-8510

  • Research Site

    Kanazawa, 920-8650

  • Research Site

    Kasugai-shi, 487-0016

  • Research Site

    Kawasaki-shi, 210-0852

  • Research Site

    Kishiwada-shi, 596-8522

  • Research Site

    Kobe, 654-0155

  • Research Site

    Koga-shi, 306-0041

  • Research Site

    Kuki-shi, 346-0021

  • Research Site

    Kure-shi, 737-0023

  • Research Site

    Kyoto, 612-8555

  • Research Site

    Matsumoto-shi, 390-8621

  • Research Site

    Mito, 311-4198

  • Research Site

    Miura-gun, 240-0116

  • Research Site

    Nakagami-gun, 901-2393

  • Research Site

    Nishinomiya-shi, 663-8501

  • Research Site

    Ōita, 870-0855

  • Research Site

    Saga, 840-8571

  • Research Site

    Sagamihara-shi, 252-5188

  • Research Site

    Sapporo, 063-0005

  • Research Site

    Shinagawa-ku, 140-8522

  • Research Site

    Suita-shi, 564-8565

  • Research Site

    Takamatsu, 760-0018

  • Research Site

    Takasago-shi, 676-0812

  • Research Site

    Toride-shi, 302-0022

  • Research Site

    Tsu, 514-1101

  • Research Site

    Tsuchiura-shi, 300-0028

  • Research Site

    Ueda-shi, 386-8610

  • Research Site

    Ureshino-shi, 843-0393

  • Research Site

    Utsunomiya, 320-8580

Other trials in Japan

China35 sites

  • Research Site

    Baotou, 014010

  • Research Site

    Beijing, 100029

  • Research Site

    Beijing, 100049

  • Research Site

    Beijing, 100853

  • Research Site

    Cangzhou, 061001

  • Research Site

    Changchun, 130021

  • Research Site

    Changchun, 130033

  • Research Site

    Chengdu, 610041

  • Research Site

    Chifeng, 024000

  • Research Site

    Dalian, 116011

  • Research Site

    Daqing, 163000

  • Research Site

    Fuzhou, 350025

  • Research Site

    Fuzhou, 350031

  • Research Site

    Guangzhou, 510100

  • Research Site

    Guangzhou, 510120

  • Research Site

    Haerbin, 150001

  • Research Site

    Jinan, 250013

  • Research Site

    Lanzhou, 730030

  • Research Site

    Nanchang, 330006

  • Research Site

    Nanjing, 2100008

  • Research Site

    Nanjing, 210009

  • Research Site

    Nanjing, 210011

  • Research Site

    Pingxiang, 337055

  • Research Site

    Shanghai, 200025

  • Research Site

    Shanghai, 200062

  • Research Site

    Shanghai, 200090

  • Research Site

    Shenyang, 110015

  • Research Site

    Tianjin, 300000

  • Research Site

    Tianjin, 300142

  • Research Site

    Tianjin, 300211

  • Research Site

    Tianjin, 300457

  • Research Site

    Wuhan, 430000

  • Research Site

    Wuhan, 430033

  • Research Site

    Xi'an, 710061

  • Research Site

    Yinchuan, 750004

Other trials in China

Canada22 sites

  • Research Site

    Brampton, Ontario, L6W 2X7

  • Research Site

    Brampton, Ontario, L6Z 4N5

  • Research Site

    Burlington, Ontario, L7M 4Y1

  • Research Site

    Cambridge, Ontario, N1R 6V6

  • Research Site

    Hamilton, Ontario, L8L 2X2

  • Research Site

    Laval, Quebec, H7M 3L9

  • Research Site

    Montreal, Quebec, H1T 1C8

  • Research Site

    Newmarket, Ontario, L3Y 2P6

  • Research Site

    North York, Ontario, M6B 3H7

  • Research Site

    Oshawa, Ontario, L1J 2K1

  • Research Site

    Port Perry, Ontario, L9L 1L1

  • Research Site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Research Site

    Scarborough Village, Ontario, M1B 4Z8

  • Research Site

    Terrebonne, Quebec, J6V 2H2

  • Research Site

    Toronto, Ontario, M3N 1N1

  • Research Site

    Toronto, Ontario, M5B 1W8

  • Research Site

    Toronto, Ontario, M6G 1M2

  • Research Site

    Toronto, Ontario, M6N 1B5

  • Research Site

    Trois-Rivières, Quebec, G8Z 3R9

  • Research Site

    Waterloo, Ontario, N2T 0C1

  • Research Site

    Winnipeg, Manitoba, R2H 2A6

  • Research Site

    York, Ontario, M9N 1W4

Other trials in Canada

Argentina19 sites

  • Research Site

    Buenos Aires, C1426ABP

  • Research Site

    CABA, 1426

  • Research Site

    CABA, C1119ACN

  • Research Site

    CABA, C1120AAC

  • Research Site

    CABA, C1425AGC

  • Research Site

    Catamarca, K4700

  • Research Site

    Ciudad Autonoma de Buenos Aire, C1407GTN

  • Research Site

    Córdoba, 5003

  • Research Site

    Córdoba, X5000AAW

  • Research Site

    Córdoba, X5003DCP

  • Research Site

    Córdoba, X5004BAL

  • Research Site

    Córdoba, X5006CBI

  • Research Site

    Corrientes, W3400AMZ

  • Research Site

    Mar del Plata, 7600

  • Research Site

    Ramos Mejía, B1704ETD

  • Research Site

    Rosario, 2000

  • Research Site

    San Miguel de Tucumán, 4000

  • Research Site

    San Nicolás, B2900DMH

  • Research Site

    Santa Fe, S3000FWO

Other trials in Argentina

Poland17 sites

  • Research Site

    Bialystok, 15-111

  • Research Site

    Bochnia, 32-700

  • Research Site

    Chojnice, 89-600

  • Research Site

    Gdansk, 80-286

  • Research Site

    Gdynia, 81-157

  • Research Site

    Gdynia, 81-423

  • Research Site

    Jasło, 38-200

  • Research Site

    Katowice, 40-081

  • Research Site

    Lodz, 92-213

  • Research Site

    Lublin, 20-044

  • Research Site

    Oława, 55-200

  • Research Site

    Opole, 45-056

  • Research Site

    Płock, 09-402

  • Research Site

    Rzeszów, 35-055

  • Research Site

    Torun, 87-100

  • Research Site

    Wierzchosławice, 33-122

  • Research Site

    Wroclaw, 50-981

Other trials in Poland

Russia14 sites

  • Research Site

    Chelyabinsk, 454091

  • Research Site

    Moscow, 109263

  • Research Site

    Moscow, 111539

  • Research Site

    Moscow, 117292

  • Research Site

    Moscow, 119991

  • Research Site

    Moscow, 121552

  • Research Site

    Novosibirsk, 630055

  • Research Site

    Perm, 614056

  • Research Site

    Ryazan, 390039

  • Research Site

    Saint Petersburg, 191015

  • Research Site

    Saint Petersburg, 194354

  • Research Site

    Saint Petersburg, 198260

  • Research Site

    Saint Petersburg, 199226

  • Research Site

    Tver', 170036

Other trials in Russia

Brazil13 sites

  • Research Site

    Belo Horizonte, 30150-240

  • Research Site

    Belo Horizonte, 30210-090

  • Research Site

    Blumenau, 89020-430

  • Research Site

    Campina Grande do Sul, 83430000

  • Research Site

    Campinas, 13010-001

  • Research Site

    Campinas, 13060-080

  • Research Site

    Curitiba, 80230-130

  • Research Site

    Porto Alegre, 90020090

  • Research Site

    Porto Alegre, 90035-903

  • Research Site

    Rio de Janeiro, 20241-180

  • Research Site

    Santo André, 09080-110

  • Research Site

    São Paulo, 01141-020

  • Research Site

    Votuporanga, 15500-003

Other trials in Brazil

Bulgaria13 sites

  • Research Site

    Dimitrovgrad, 6400

  • Research Site

    Haskovo

  • Research Site

    Kozloduy, 3320

  • Research Site

    Pazardzhik, 4400

  • Research Site

    Pleven, 5800

  • Research Site

    Plovdiv, 4004

  • Research Site

    Sofia, 1309

  • Research Site

    Sofia, 1431

  • Research Site

    Sofia, 1463

  • Research Site

    Sofia, 1606

  • Research Site

    Sofia, 1700

  • Research Site

    Sofia, 1784

  • Research Site

    Stara Zagora, 6000

Other trials in Bulgaria

Mexico13 sites

  • Research Site

    Aguascalientes, 20230

  • Research Site

    Culiacán, 80200

  • Research Site

    Guadalajara, 44210

  • Research Site

    Mazatlán, 82000

  • Research Site

    México, 06700

  • Research Site

    México, 11650

  • Research Site

    Monclova, 25750

  • Research Site

    Monterrey, 64020

  • Research Site

    Monterrey, 64060

  • Research Site

    Querétaro, 76000

  • Research Site

    Tijuana, 22150

  • Research Site

    Veracruz, 91900

  • Research Site

    Veracruz, 91910

Other trials in Mexico

Peru13 sites

  • Research Site

    Bellavista, CALLAO 2

  • Research Site

    Callao, CALLAO 2

  • Research Site

    Chancay, 15131

  • Research Site

    Chorrillos, Lima 9

  • Research Site

    Lima, 14

  • Research Site

    Lima, 15088

  • Research Site

    Lima, L11

  • Research Site

    Lima, L18

  • Research Site

    Lima, LIMA 1

  • Research Site

    Lima, LIMA 31

  • Research Site

    Lima, LIMA 41

  • Research Site

    San Isidro, 15073

  • Research Site

    Urb. El Chipe, 20007

Other trials in Peru

Taiwan13 sites

  • Research Site

    Hsinchu, 300

  • Research Site

    Kaohsiung City, 80756

  • Research Site

    Kaohsiung City, 82445

  • Research Site

    Taichung, 40201

  • Research Site

    Taichung, 40705

  • Research Site

    Taichung

  • Research Site

    Tainan, 704

  • Research Site

    Taipei, 110

  • Research Site

    Taipei, 11217

  • Research Site

    Taipei, 11220

  • Research Site

    Taipei, 114

  • Research Site

    Taipei

  • Research Site

    Taoyuan City, 333

Other trials in Taiwan

Hungary12 sites

  • Research Site

    Budapest, 1122

  • Research Site

    Budapest, 1139

  • Research Site

    Budapest, 1171

  • Research Site

    Győr, 9024

  • Research Site

    Kecskemét, 6000

  • Research Site

    Miskolc, 3529

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Székesfehérvár, 8000

  • Research Site

    Szekszárd, 7100

  • Research Site

    Szentes, 6600

  • Research Site

    Szolnok, 5000

  • Research Site

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia11 sites

  • Research Site

    Benešov, 256 01

  • Research Site

    Brandýs nad Labem, 250 01

  • Research Site

    Brno, 612 00

  • Research Site

    Jaroměř, 551 01

  • Research Site

    Kladno, 272 80

  • Research Site

    Louny, 440 01

  • Research Site

    Náchod, 547 01

  • Research Site

    Ostrava-Dubina, 700 30

  • Research Site

    Pardubice, 532 03

  • Research Site

    Prague, 12808

  • Research Site

    Příbram, 261 01

Other trials in Czechia

Netherlands11 sites

  • Research Site

    Amsterdam, 1061 AE

  • Research Site

    Arnhem, 6815 AD

  • Research Site

    Dordrecht, 3318 AT

  • Research Site

    Groningen, 9700 RB

  • Research Site

    Heerlen, 6419 PC

  • Research Site

    Leiderdorp, 2353 GA

  • Research Site

    Meppel, 7943 KA

  • Research Site

    Rotterdam, 3083 AN

  • Research Site

    The Hague, 2545 AA

  • Research Site

    Uden, 5406 PT

  • Research Site

    Veldhoven, 5504 DB

Other trials in Netherlands

Spain11 sites

  • Research Site

    A Coruña, 15006

  • Research Site

    Barcelona, 08003

  • Research Site

    Hospitalet de Llobregat(Barcel, 08907

  • Research Site

    Madrid, 28040

  • Research Site

    Madrid, 28041

  • Research Site

    Sanlúcar de Barrameda (Cádiz), 11540

  • Research Site

    Santiago(A Coruña), 15706

  • Research Site

    Seville, 41071

  • Research Site

    Valencia, 46010

  • Research Site

    Valencia, 46026

  • Research Site

    Villamartín (Cádiz), 11650

Other trials in Spain

Belgium6 sites

  • Research Site

    Aalst, 9300

  • Research Site

    Brasschaat, 2930

  • Research Site

    Brussels, 1200

  • Research Site

    Huy, 4500

  • Research Site

    Kortrijk, 8500

  • Research Site

    Leuven, 3000

Other trials in Belgium

Romania6 sites

  • Research Site

    Brasov, 500365

  • Research Site

    Craiova, 200642

  • Research Site

    Iași, 700304

  • Research Site

    Iași, 700400

  • Research Site

    Iași, 700515

  • Research Site

    Tg Mures, 540143

Other trials in Romania

Saudi Arabia6 sites

  • Research Site

    Dammam, 31463

  • Research Site

    Jeddah, 21499

  • Research Site

    Jeddah, 22252

  • Research Site

    Riyadh, 11426

  • Research Site

    Riyadh, 11462

  • Research Site

    Riyadh, 11525

Other trials in Saudi Arabia

Vietnam4 sites

  • Research Site

    Hanoi, 100000

  • Research Site

    Ho Chi Minh City, 700000

  • Research Site

    Ho Chi Minh City, 70000

  • Research Site

    Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

Read the detailed description

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind study in patients with HFpEF, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death and heart failure events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for 24 hours can be randomised. It is estimated that approximately 11000 patients at approximately 400-500 sites in 20-25 countries will need to be enrolled to reach the target of approximately 6100 randomised patients.

Being tested
Dapagliflozin, Placebo

What participants receive

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

  • DapagliflozinDrug

    Also called Forxiga TM, Farxiga TM

    10 mg tablets given once daily, per oral use.

  • PlaceboDrug

    Placebo matching dapagliflozin 10 mg

Study groups in NCT03619213
Study groupRoleWhat they receive
DapagliflozinExperimentalPatients will be randomized 1:1 to either dapagliflozin or placebo.
Receives: Drug: Dapagliflozin
PlaceboPlacebo comparatorPlacebo matching dapagliflozin.
Receives: Drug: Placebo

What is being measured

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

  1. Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.

    Dual primary efficacy

    Primary endpoint analysed in all patients randomised (Full analysis set).

    The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.

    Measured: Up to 42.1 months

  2. Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation

    Dual primary efficacy

    Primary endpoint analysed in all patients randomised with LVEF < 60% at baseline.

    The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.

    Measured: Up to 42.1 months

Secondary outcomes (5)

  1. Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit)

    Secondary efficacy

    Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients.

    The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.

    Measured: Up to 42.1 months

  2. Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation

    Secondary efficacy

    Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients with LVEF < 60% at baseline

    The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.

    Measured: Up to 42.1 months

  3. Change From Baseline in the KCCQ Total Symptom Score at 8 Months

    KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

    Measured: Baseline and 8 months or death before 8 months

  4. Subjects Included in the Endpoint of Cardiovascular Death

    Secondary efficacy

    The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.

    Measured: Up to 42.1 months

  5. Subjects Included in the Endpoint of All-cause Mortality

    Secondary efficacy

    The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.

    Measured: Up to 42.1 months

Timeline

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

  1. First posted7 Aug 2018
  2. Study start27 Aug 2018
  3. Primary completion27 Mar 2022
  4. Study completion27 Mar 2022

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
Model description
International, Double-blind, Randomised, Placebo-Controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03619213
Sponsor's protocol ID
D169CC00001
Other IDs
2018-000802-46, 2018
Acronym
DELIVER
Status last verified
Jul 2023
First submitted
2 Aug 2018
Last updated
11 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

  • Lu 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 42669134

  • Myte R, Mattsson A, Poole M, Little DJ, Nystrom P, Henderson A, Claggett BL, Gasparyan SB, Solomon SD, McMurray JJV. Survival Odds to Minimize Risk Heterogeneity Bias in Heart Failure Trials: Application to Dapagliflozin. Circ Heart Fail. 2025 Dec;18(12):e013496. doi: 10.1161/CIRCHEARTFAILURE.125.013496. Epub 2025 Oct 31.

    PubMed 41170566

  • Ostrominski JW, Neuen BL, Claggett BL, Anand IS, Desai AS, Jhund PS, Lam CSP, Pfeffer MA, Pitt B, Zannad F, Zile MR, Packer M, Docherty KF, McMurray JJV, Solomon SD, Vaduganathan M. Natriuretic Peptides, Body Mass Index, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. J Am Coll Cardiol. 2025 Nov 18;86(20):1823-1839. doi: 10.1016/j.jacc.2025.08.028. Epub 2025 Aug 27.

    PubMed 40892613

  • Siqueira SRO, Pabon MA, Vaduganathan M, Claggett BL, Lam CSP, Kosiborod MN, de Boer RA, Shah SJ, Fang JC, Desai AS, Jhund PS, Inzucchi SE, Martinez F, Hernandez AF, Petersson M, McMurray JJV, Solomon SD, Vardeny O. Achieved Ejection Fraction and Effects of Dapagliflozin in Heart Failure With Improved Ejection Fraction. JACC Heart Fail. 2025 Oct;13(10):102585. doi: 10.1016/j.jchf.2025.102585. Epub 2025 Aug 19.

    PubMed 40834567

  • Inciardi RM, Lu H, Claggett BL, Desai AS, Jhund PS, Lam CSP, Kosiborod MN, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Kober L, Ponikowski P, Sabatine MS, Petersson M, Langkilde AM, McMurray JJV, Vaduganathan M, Solomon SD. Severe Heart Failure and Treatment With Dapagliflozin Across the Ejection Fraction Spectrum: DAPA-HF and DELIVER. JACC Heart Fail. 2025 Apr;13(4):618-627. doi: 10.1016/j.jchf.2024.11.023. Epub 2025 Mar 5.

    PubMed 40047763

  • Yang M, Kondo T, Talebi A, Jhund PS, Docherty KF, Claggett BL, Vaduganathan M, Bachus E, Hernandez AF, Lam CSP, Martinez FA, de Boer RA, Kosiborod MN, Desai AS, Kober L, Ponikowski P, Sabatine MS, Solomon SD, McMurray JJV. EuroQol 5-Dimension Questionnaire in Heart Failure With Reduced, Mildly Reduced, and Preserved Ejection Fraction: A Patient-Level Analysis of DAPA-HF and DELIVER. JACC Heart Fail. 2025 Feb;13(2):277-292. doi: 10.1016/j.jchf.2024.10.020.

    PubMed 39909641

  • Lu H, Kondo T, Claggett BL, Vaduganathan M, Neuen BL, Beldhuis IE, Jhund PS, Mc Causland FR, Anand IS, Pfeffer MA, Pitt B, Zannad F, Zile MR, McMurray JJV, Solomon SD, Desai AS. Systolic Blood Pressure and Pulse Pressure in Heart Failure: Pooled Participant-Level Analysis of 4 Trials. J Am Coll Cardiol. 2025 Feb 25;85(7):710-722. doi: 10.1016/j.jacc.2024.11.007. Epub 2024 Nov 15.

    PubMed 39745404

  • Kondo T, Gasparyan SB, Jhund PS, Bengtsson O, Claggett BL, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Kober L, Lam CSP, Langkilde AM, Martinez FA, Petersson M, Ponikowski P, Sabatine MS, Shah SJ, Sjostrand M, Wilderang U, Vaduganathan M, Solomon SD, McMurray JJV. Use of Win Statistics to Analyze Outcomes in the DAPA-HF and DELIVER Trials. NEJM Evid. 2023 Nov;2(11):EVIDoa2300042. doi: 10.1056/EVIDoa2300042. Epub 2023 Oct 24.

    PubMed 38320525

  • Vardeny O, Desai AS, Jhund PS, Fang JC, Claggett B, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez FA, Shah SJ, Mc Causland FR, Petrie MC, Vaduganathan M, McMurray JJV, Solomon SD. Dapagliflozin and Mode of Death in Heart Failure With Improved Ejection Fraction: A Post Hoc Analysis of the DELIVER Trial. JAMA Cardiol. 2024 Mar 1;9(3):283-289. doi: 10.1001/jamacardio.2023.5318.

    PubMed 38265835

  • Mc Causland FR, Claggett BL, Vaduganathan M, Desai A, Jhund P, Vardeny O, Fang JC, de Boer RA, Docherty KF, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Saraiva JFK, McGrath MM, Shah SJ, Verma S, Langkilde AM, Petersson M, McMurray JJV, Solomon SD. Decline in Estimated Glomerular Filtration Rate After Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Secondary Analysis of the DELIVER Randomized Clinical Trial. JAMA Cardiol. 2024 Feb 1;9(2):144-152. doi: 10.1001/jamacardio.2023.4664.

    PubMed 37952176

  • Kondo T, Butt JH, Curtain JP, Jhund PS, Docherty KF, Claggett BL, Vaduganathan M, Bachus E, Hernandez AF, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Kosiborod MN, Desai AS, Kober L, Ponikowski P, Sabatine MS, Solomon SD, McMurray JJV. Efficacy of Dapagliflozin According to Heart Rate: A Patient-Level Pooled Analysis of DAPA-HF and DELIVER. Circ Heart Fail. 2023 Dec;16(12):e010898. doi: 10.1161/CIRCHEARTFAILURE.123.010898. Epub 2023 Oct 27.

    PubMed 37886880

  • Ostrominski JW, Vaduganathan M, Selvaraj S, Claggett BL, Miao ZM, Desai AS, Jhund PS, Kosiborod MN, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Petersson M, Maria Langkilde A, McMurray JJV, Solomon SD. Dapagliflozin and Apparent Treatment-Resistant Hypertension in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: The DELIVER Trial. Circulation. 2023 Dec 12;148(24):1945-1957. doi: 10.1161/CIRCULATIONAHA.123.065254. Epub 2023 Oct 13.

    PubMed 37830208

  • Bhatt AS, Kosiborod MN, Claggett BL, Miao ZM, Vaduganathan M, Lam CSP, Hernandez AF, Martinez FA, Inzucchi SE, Shah SJ, de Boer RA, Jhund PS, Desai AS, Fang JC, Han Y, Comin-Colet J, Drozdz J, Vardeny O, Merkely B, Lindholm D, Peterson M, Langkilde AM, McMurray JJV, Solomon SD. Impact of COVID-19 in patients with heart failure with mildly reduced or preserved ejection fraction enrolled in the DELIVER trial. Eur J Heart Fail. 2023 Dec;25(12):2177-2188. doi: 10.1002/ejhf.3043. Epub 2023 Oct 9.

    PubMed 37771274

  • Peikert A, Bart BA, Vaduganathan M, Claggett BL, Kulac IJ, Kosiborod MN, Desai AS, Jhund PS, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Petersson M, Langkilde AM, McMurray JJV, Solomon SD, Vardeny O. Contemporary Use and Implications of Beta-Blockers in Patients With HFmrEF or HFpEF: The DELIVER Trial. JACC Heart Fail. 2024 Apr;12(4):631-644. doi: 10.1016/j.jchf.2023.09.007. Epub 2023 Sep 27.

    PubMed 37767674

  • Chatur S, Vaduganathan M, Claggett BL, Mc Causland FR, Desai AS, Jhund PS, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez FA, Shah SJ, Sabatine MS, Kober L, Ponikowski P, Merkely B, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Dapagliflozin in Patients With Heart Failure and Deterioration in Renal Function. J Am Coll Cardiol. 2023 Nov 7;82(19):1854-1863. doi: 10.1016/j.jacc.2023.08.026. Epub 2023 Aug 25.

    PubMed 37634707

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Heart Failure With Preserved Ejection Fraction, run by AstraZeneca at 348 sites in 20 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 7 inclusion and 11 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 348 sites in United States, Japan, China, Canada, Argentina and 15 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 11 Jul 2023). 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?

Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. (time frame: Up to 42.1 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 NCT03619213, which also lists 49 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 11 Jul 2023.

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