Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) Clinical Trial
— DAPA-HFOfficial title:
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction
| Verified date | August 2020 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction
| Status | Completed |
| Enrollment | 4744 |
| Est. completion date | July 17, 2019 |
| Est. primary completion date | July 17, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility |
Inclusion Criteria: - Provision of signed informed consent prior to any study specific procedures - Male or female, aged =18 years - Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months - LVEF=40% - Elevated NT-proBNP levels - Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines - eGFR =30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1) Exclusion Criteria: - Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor - Type 1 diabetes mellitus - Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2 - Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment - MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment - Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization - Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device - Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization - HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease - Symptomatic bradycardia or second or third degree heart block without a pacemaker - Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Ciudad Autonoma Buenos Aires | |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aire | |
| Argentina | Research Site | Ciudad de Buenos Aires | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Corrientes | |
| Argentina | Research Site | Esperanza | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Quilmes | |
| Argentina | Research Site | Quilmes | |
| Argentina | Research Site | Ramos Mejía | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | San Luis | |
| Argentina | Research Site | San Martin | |
| Argentina | Research Site | San Miguel de Tucuman | |
| Argentina | Research Site | San Nicolás | |
| Argentina | Research Site | Santa Fe | |
| Argentina | Research Site | Vicente Lopez | |
| Brazil | Research Site | Belo Horizonte | |
| Brazil | Research Site | Belo Horizonte | |
| Brazil | Research Site | Brasilia | |
| Brazil | Research Site | Brasillia | |
| Brazil | Research Site | Campina Grande do Sul | |
| Brazil | Research Site | Campinas | |
| Brazil | Research Site | Curitiba | |
| Brazil | Research Site | Goiânia | |
| Brazil | Research Site | Marilia | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Rio de Janeiro | |
| Brazil | Research Site | São José do Rio Preto | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | Uberlandia | |
| Brazil | Research Site | Votuporanga | |
| Bulgaria | Research Site | Blagoevgrad | |
| Bulgaria | Research Site | Dimitrovgrad | |
| Bulgaria | Research Site | Haskovo | |
| Bulgaria | Research Site | Kyustendil | |
| Bulgaria | Research Site | Lom | |
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Canada | Research Site | Abbotsford | British Columbia |
| Canada | Research Site | Brampton | Ontario |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Cambridge | Ontario |
| Canada | Research Site | Cambridge | Ontario |
| Canada | Research Site | Greenfield Park | Quebec |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Moncton | New Brunswick |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | New Westminster | British Columbia |
| Canada | Research Site | Newmarket | Ontario |
| Canada | Research Site | North Vancouver | British Columbia |
| Canada | Research Site | North York | Ontario |
| Canada | Research Site | Oakville | Ontario |
| Canada | Research Site | Oshawa | Ontario |
| Canada | Research Site | Peterborough | Ontario |
| Canada | Research Site | Port Perry | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Rimouski | Quebec |
| Canada | Research Site | Saint John | New Brunswick |
| Canada | Research Site | Saint-Jerome | Quebec |
| Canada | Research Site | Scarborough | Ontario |
| Canada | Research Site | Scarborough | Ontario |
| Canada | Research Site | Terrebonne | Quebec |
| Canada | Research Site | Waterloo | Ontario |
| Canada | Research Site | York | Ontario |
| China | Research Site | Baotou | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Bengbu | |
| China | Research Site | Changchun | |
| China | Research Site | Changsha | |
| China | Research Site | Chifeng | |
| China | Research Site | Dalian | |
| China | Research Site | Guangzhou | |
| China | Research Site | Haerbin | |
| China | Research Site | Lanzhou | |
| China | Research Site | Nanchang | |
| China | Research Site | Nanjing | |
| China | Research Site | Nanjing | |
| China | Research Site | Ningbo | |
| China | Research Site | Pingxiang | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shenyang | |
| China | Research Site | Shenzhen | |
| China | Research Site | Tianjin | |
| China | Research Site | Wuhan | |
| China | Research Site | Wuhan | |
| China | Research Site | Xuzhou | |
| China | Research Site | Xuzhou | |
| China | Research Site | Yinchuan | |
| China | Research Site | Zhuhai | |
| Czechia | Research Site | Benesov | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Kolin | |
| Czechia | Research Site | Louny | |
| Czechia | Research Site | Ostrava-Dubina | |
| Czechia | Research Site | Plzen | |
| Czechia | Research Site | Praha | |
| Czechia | Research Site | Praha 2 | |
| Czechia | Research Site | Praha 4 | |
| Czechia | Research Site | Praha 5 | |
| Czechia | Research Site | Trebic | |
| Denmark | Research Site | Hellerup | |
| Denmark | Research Site | Herlev | |
| Denmark | Research Site | Hvidovre | |
| Denmark | Research Site | København Ø | |
| Denmark | Research Site | Odense C | |
| Denmark | Research Site | Svendborg | |
| Germany | Research Site | Bad Oeynhausen | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Homburg | |
| Germany | Research Site | Kassel | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Papenburg | |
| Germany | Research Site | Stuttgart | |
| Germany | Research Site | Wermsdorf | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Kecskemét | |
| Hungary | Research Site | Mosonmagyaróvár | |
| Hungary | Research Site | Székesfehérvár | |
| Hungary | Research Site | Szentes | |
| Hungary | Research Site | Zalaegerszeg | |
| India | Research Site | Ahmedabad | |
| India | Research Site | Aurangabad | |
| India | Research Site | Bangalore | |
| India | Research Site | Belagavi | |
| India | Research Site | Ernakulam | |
| India | Research Site | Gurgaon | |
| India | Research Site | Kanpur | |
| India | Research Site | Karamsad | |
| India | Research Site | Kolkata | |
| India | Research Site | Maharashtra | |
| India | Research Site | Nadiad | |
| India | Research Site | Nagpur | |
| India | Research Site | Nagpur | |
| India | Research Site | New Delhi | |
| India | Research Site | Pune | |
| India | Research Site | Pune | |
| Japan | Research Site | Adachi-ku | |
| Japan | Research Site | Aki-gun, | |
| Japan | Research Site | Azumino-shi | |
| Japan | Research Site | Beppu-shi | |
| Japan | Research Site | Bunkyo-ku | |
| Japan | Research Site | Chikushino-shi | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Fujisawa-shi | |
| Japan | Research Site | Fujisawa-shi | |
| Japan | Research Site | Fukuoka-shi | |
| Japan | Research Site | Hachioji-shi | |
| Japan | Research Site | Hamamatsu-shi | |
| Japan | Research Site | Himeji-shi | |
| Japan | Research Site | Hiratsuka-shi | |
| Japan | Research Site | Hitachinaka-shi | |
| Japan | Research Site | Iizuka-shi | |
| Japan | Research Site | Itabashi-ku | |
| Japan | Research Site | Iwakuni-shi | |
| Japan | Research Site | Kagoshima-shi | |
| Japan | Research Site | Kakamigahara-shi | |
| Japan | Research Site | Kasama-shi | |
| Japan | Research Site | Kishiwada-shi | |
| Japan | Research Site | Kitakyusyu-shi | |
| Japan | Research Site | Kumamoto-shi | |
| Japan | Research Site | Kure-shi | |
| Japan | Research Site | Kusatsu-shi | |
| Japan | Research Site | Kyoto-shi | |
| Japan | Research Site | Matsudo-shi | |
| Japan | Research Site | Matsudo-shi | |
| Japan | Research Site | Matsumoto-shi | |
| Japan | Research Site | Matsuyama-shi | |
| Japan | Research Site | Meguro-ku | |
| Japan | Research Site | Mito-shi | |
| Japan | Research Site | Miura-gun | |
| Japan | Research Site | Nagasaki-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Nishinomiya-shi | |
| Japan | Research Site | Okayama-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Sagamihara-shi | |
| Japan | Research Site | Sakai-shi,Kita-ku | |
| Japan | Research Site | Sakaide-shi | |
| Japan | Research Site | Sanyoonoda-shi | |
| Japan | Research Site | Sayama-shi | |
| Japan | Research Site | Sendai-shi | |
| Japan | Research Site | Sendai-shi | |
| Japan | Research Site | Shimonoseki-shi | |
| Japan | Research Site | Shinjuku-ku | |
| Japan | Research Site | Suita-shi | |
| Japan | Research Site | Suwa-shi | |
| Japan | Research Site | Tachikawa-shi | |
| Japan | Research Site | Takamatsu-shi | |
| Japan | Research Site | Takasaki-shi | |
| Japan | Research Site | Toride-shi | |
| Japan | Research Site | Tsuchiura-shi | |
| Japan | Research Site | Tsukuba-shi | |
| Japan | Research Site | Ueda-shi | |
| Japan | Research Site | Wakayama-shi | |
| Japan | Research Site | Wakayama-shi | |
| Japan | Research Site | Wako-shi | |
| Japan | Research Site | Yokohama-shi | |
| Netherlands | Research Site | Apeldoorn | |
| Netherlands | Research Site | Den Bosch | |
| Netherlands | Research Site | Den Haag | |
| Netherlands | Research Site | Gouda | |
| Netherlands | Research Site | Groningen | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Sneek | |
| Netherlands | Research Site | Veldhoven | |
| Poland | Research Site | Bochnia | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Jaslo | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Kedzierzyn Kozle | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Legnica | |
| Poland | Research Site | Lódz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Olawa | |
| Poland | Research Site | Plock | |
| Poland | Research Site | Sokólka | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Wierzchoslawice | |
| Russian Federation | Research Site | Ekaterinburg | |
| Russian Federation | Research Site | Gatchina | |
| Russian Federation | Research Site | Izhevsk | |
| Russian Federation | Research Site | Kazan | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Novosibirsk | |
| Russian Federation | Research Site | Perm | |
| Russian Federation | Research Site | Ryazan | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | St. Petersburg | |
| Russian Federation | Research Site | Tver | |
| Russian Federation | Research Site | Yekaterinburg | |
| Slovakia | Research Site | Brezno | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Lucenec | |
| Slovakia | Research Site | Martin | |
| Slovakia | Research Site | Nove Zamky | |
| Slovakia | Research Site | Presov | |
| Slovakia | Research Site | Svidnik | |
| Slovakia | Research Site | Trebisov | |
| Slovakia | Research Site | Trnava | |
| Slovakia | Research Site | Zilina | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Ostersund | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Umeå | |
| Taiwan | Research Site | Changhua City | |
| Taiwan | Research Site | Hsinchu | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Kweishan Shiang | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| United Kingdom | Research Site | Airdrie | |
| United Kingdom | Research Site | Clydebank | |
| United Kingdom | Research Site | Cottingham | |
| United Kingdom | Research Site | Dundee | |
| United Kingdom | Research Site | Edinburgh | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Inverness | |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Paisley | |
| United States | Research Site | Alexandria | Louisiana |
| United States | Research Site | Altoona | Pennsylvania |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Bakersfield | California |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Beaumont | Texas |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Bridgewater | New Jersey |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Burlington | North Carolina |
| United States | Research Site | Chalmette | Louisiana |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Cortlandt Manor | New York |
| United States | Research Site | Cumming | Georgia |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Fairhope | Alabama |
| United States | Research Site | Falls Church | Virginia |
| United States | Research Site | Farmington | Utah |
| United States | Research Site | Flint | Michigan |
| United States | Research Site | Flint | Michigan |
| United States | Research Site | Grand Island | Nebraska |
| United States | Research Site | Great Falls | Montana |
| United States | Research Site | Haverhill | Massachusetts |
| United States | Research Site | Hazel Crest | Illinois |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jerseyville | Illinois |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Kingwood | Texas |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | Lake Worth | Florida |
| United States | Research Site | Lansing | Michigan |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lincoln | Nebraska |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Naples | Florida |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Brunswick | New Jersey |
| United States | Research Site | New Smyrna Beach | Florida |
| United States | Research Site | New York | New York |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orchard Park | New York |
| United States | Research Site | Palm Springs | California |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Peoria | Illinois |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Poughkeepsie | New York |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rosedale | New York |
| United States | Research Site | Saint Augustine | Florida |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Sheffield | Alabama |
| United States | Research Site | Somerset | New Jersey |
| United States | Research Site | Stockton | California |
| United States | Research Site | Torrance | California |
| United States | Research Site | Tucker | Georgia |
| United States | Research Site | Tullahoma | Tennessee |
| United States | Research Site | Tupelo | Mississippi |
| United States | Research Site | Tyler | Texas |
| United States | Research Site | Vista | California |
| United States | Research Site | Wellington | Florida |
| United States | Research Site | Wilmington | Delaware |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Hcmc | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Argentina, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Germany, Hungary, India, Japan, Netherlands, Poland, Russian Federation, Slovakia, Sweden, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. | Primary efficacy | Up to 27.8 months. | |
| Secondary | Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. | Secondary | Up to 27.8 months. | |
| Secondary | Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death. | Secondary | Up to 27.8 months. | |
| Secondary | Change From Baseline in the KCCQ Total Symptom Score | 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. | Baseline and 8 months or death before 8 months | |
| Secondary | Subjects Included in the Composite Endpoint of =50% Sustained Decline in eGFR, ESRD or Renal Death. | Secondary | Up to 27.8 months. | |
| Secondary | Subjects Included in the Endpoint of All-cause Mortality. | Secondary | Up to 27.8 months. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01876433 -
Beta 3 Agonist Treatment in Heart Failure
|
Phase 2 |