Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
Launched by ASTRAZENECA · Aug 2, 2018
Trial Information
Current as of May 18, 2025
Completed
Keywords
ClinConnect Summary
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 t...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Provision of signed informed consent prior to any study specific procedures.
- • 2. Male or female patients age ≥40 years.
- • 3. 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.
- • 4. 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.
- • 5. Elevated NT-pro BNP levels.
- • 6. 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.
- Exclusion Criteria:
- • 1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
- • 2. Type 1 diabetes mellitus (T1D).
- • 3. eGFR \<25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
- • 4. Systolic blood pressure (BP) \<95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
- • 5. 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.
- • 6. 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.
- • 7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
- • 8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
- • 9. 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).
- • 10. Body mass index \>50 kg/m2.
- • Further exclusion criteria may apply
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Tucson, Arizona, United States
Rochester, Minnesota, United States
Rochester, New York, United States
Nashville, Tennessee, United States
Port Charlotte, Florida, United States
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Brasschaat, , Belgium
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
A Coruña, , Spain
Madrid, , Spain
Sevilla, , Spain
San Antonio, Texas, United States
Haskovo, , Bulgaria
Louisville, Kentucky, United States
New York, New York, United States
Leuven, , Belgium
Madrid, , Spain
Barcelona, , Spain
Burlington, Vermont, United States
Torun, , Poland
Chicago, Illinois, United States
Kansas City, Kansas, United States
Mobile, Alabama, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Anderson, Indiana, United States
Lansing, Michigan, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Lebanon, New Hampshire, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Anderson, South Carolina, United States
Tullahoma, Tennessee, United States
Corrientes, , Argentina
Aalst, , Belgium
Huy, , Belgium
Dimitrovgrad, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Hamilton, Ontario, Canada
Benesov, , Czechia
Praha 2, , Czechia
Szolnok, , Hungary
Zalaegerszeg, , Hungary
Arnhem, , Netherlands
Heerlen, , Netherlands
Rotterdam, , Netherlands
Wroclaw, , Poland
Moscow, , Russian Federation
Tucson, Arizona, United States
Ormond Beach, Florida, United States
Ocala, Florida, United States
Morgantown, West Virginia, United States
Aguascalientes, , Mexico
Boston, Massachusetts, United States
Charleston, South Carolina, United States
Kortrijk, , Belgium
Nashville, Tennessee, United States
Jackson, Mississippi, United States
Wilmington, North Carolina, United States
Great Falls, Montana, United States
Beverly Hills, California, United States
Atlanta, Georgia, United States
Culiacán, , Mexico
Kaohsiung, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Budapest, , Hungary
Kecskemét, , Hungary
Valencia, , Spain
Miami, Florida, United States
Warwick, Rhode Island, United States
Clearwater, Florida, United States
Atlanta, Georgia, United States
Gurnee, Illinois, United States
Buffalo, New York, United States
Naples, Florida, United States
Mexico, , Mexico
Saint Louis, Missouri, United States
Oklahoma City, Oklahoma, United States
Providence, Rhode Island, United States
Saint Jerome, Quebec, Canada
Beijing, , China
Shanghai, , China
Pribram, , Czechia
Taichung, , Taiwan
Stara Zagora, , Bulgaria
Bruxelles, , Belgium
Novosibirsk, , Russian Federation
Sevilla, , Spain
Laval, Quebec, Canada
Brno, , Czechia
Munster, Indiana, United States
Morganton, North Carolina, United States
Hamilton, Ontario, Canada
Kanazawa Shi, , Japan
Greensboro, North Carolina, United States
Taipei, , Taiwan
Dordrecht, , Netherlands
Amsterdam, , Netherlands
Las Vegas, Nevada, United States
Rapid City, South Dakota, United States
Caba, , Argentina
San Miguel De Tucuman, , Argentina
Campinas, , Brazil
Cambridge, Ontario, Canada
Montreal, Quebec, Canada
Wuhan, , China
Yinchuan, , China
Szekszárd, , Hungary
Szentes, , Hungary
Meppel, , Netherlands
Płock, , Poland
Kaohsiung, , Taiwan
Hammond, Louisiana, United States
Jackson, Tennessee, United States
Oshawa, Ontario, Canada
Craiova, , Romania
Hamilton, Ontario, Canada
Leiderdorp, , Netherlands
Praha 2, , Czechia
Milwaukee, Wisconsin, United States
Changchun, , China
Chengdu, , China
Dalian, , China
Xi'an, , China
Madison, Wisconsin, United States
Fuzhou, , China
Nishinomiya Shi, , Japan
Flint, Michigan, United States
Doylestown, Pennsylvania, United States
Miskolc, , Hungary
Los Angeles, California, United States
Stamford, Connecticut, United States
Mar Del Plata, , Argentina
Ramos Mejía, , Argentina
San Nicolás, , Argentina
Santa Fe, , Argentina
Belo Horizonte, , Brazil
Campina Grande Do Sul, , Brazil
Kozloduy, , Bulgaria
Brampton, Ontario, Canada
Terrebonne, Quebec, Canada
Jinan, , China
Nanchang, , China
Monterey, , Mexico
Veracruz, , Mexico
Katowice, , Poland
Lublin, , Poland
Wierzchosławice, , Poland
Chelyabinsk, , Russian Federation
Tver, , Russian Federation
Hanoi, , Vietnam
Mount Clemens, Michigan, United States
Bridgewater, New Jersey, United States
Falls Church, Virginia, United States
Leesburg, Virginia, United States
Rosario, , Argentina
Winnipeg, Manitoba, Canada
Trois Rivieres, Quebec, Canada
Haerbin, , China
Nanjing, , China
Ostrava Dubina, , Czechia
Asahi Shi, , Japan
Beppu Shi, , Japan
Hamada Shi, , Japan
Kishiwada Shi, , Japan
Miura Gun, , Japan
Sapporo Shi, , Japan
Monclova, , Mexico
Białystok, , Poland
Gdynia, , Poland
Iasi, , Romania
Novosibirsk, , Russian Federation
Perm, , Russian Federation
Saint Petersburg, , Russian Federation
Hospitalet De Llobregat(barcel, , Spain
Ho Chi Minh, , Vietnam
Charlotte, North Carolina, United States
Brandys Nad Labem, , Czechia
Brno, , Czechia
Uden, , Netherlands
Veldhoven, , Netherlands
Wroclaw, , Poland
Saint Petersburg, , Russian Federation
Bay City, Michigan, United States
Monroe, Louisiana, United States
Saint Augustine, Florida, United States
Pardubice, , Czechia
Győr, , Hungary
Kure Shi, , Japan
Kyoto Shi, , Japan
Loma Linda, California, United States
Fairhope, Alabama, United States
Sheffield, Alabama, United States
Curitiba, , Brazil
Votuporanga, , Brazil
Pazardzhik, , Bulgaria
Waterloo, Ontario, Canada
Cangzhou, , China
Pingxiang, , China
Louny, , Czechia
Adachi Ku, , Japan
Chuo Ku, , Japan
Fujisawa Shi, , Japan
Funabashi Shi, , Japan
Hachioji Shi, , Japan
Iwakuni Shi, , Japan
Koga Shi, , Japan
Takamatsu Shi, , Japan
Ureshino Shi, , Japan
Monterrey, , Mexico
Querétaro, , Mexico
Callao, , Peru
Lima, , Peru
Bochnia, , Poland
Chojnice, , Poland
Gdańsk, , Poland
Jasło, , Poland
Opole, , Poland
Rzeszów, , Poland
Ryazan, , Russian Federation
Dammam, , Saudi Arabia
Jeddah, , Saudi Arabia
Riyadh, , Saudi Arabia
Santiago(a Coruña), , Spain
Hsinchu, , Taiwan
Taichung, , Taiwan
Guangzhou, , China
Budapest, , Hungary
Lanzhou, , China
Nakagami Gun, , Japan
Tsuchiura Shi, , Japan
Gdańsk, , Poland
Taipei City, , Taiwan
Ueda Shi, , Japan
Santo Andre, , Brazil
Shenyang, , China
Perm, , Russian Federation
Bellavista, , Peru
łódź, , Poland
Chancay, , Peru
Taoyuan City, , Taiwan
Matsumoto Shi, , Japan
Iizuka Shi, , Japan
Saga Shi, , Japan
Oita Shi, , Japan
Sherman, Texas, United States
Miami, Florida, United States
Burlington, Ontario, Canada
Koga Shi, , Japan
Toride Shi, , Japan
Brasov, , Romania
Montreal, Quebec, Canada
Humble, Texas, United States
Ciudad Autonoma De Buenos Aire, , Argentina
Cordoba, , Argentina
Córdoba, , Argentina
Newmarket, Ontario, Canada
North York, Ontario, Canada
Port Perry, Ontario, Canada
Scarborough, Ontario, Canada
York, Ontario, Canada
Baotou, , China
Chifeng, , China
Azumino Shi, , Japan
Hamamatsu Shi, , Japan
Mito Shi, , Japan
Sagamihara Shi, , Japan
Suita Shi, , Japan
Den Haag, , Netherlands
Oława, , Poland
Ho Chi Minh, , Vietnam
Kobe Shi, , Japan
Tsu Shi, , Japan
Mazatlán, , Mexico
Chorrillos, , Peru
Kasugai Shi, , Japan
México, , Mexico
Shinagawa Ku, , Japan
Oklahoma City, Oklahoma, United States
Daqing, , China
Urb. El Chipe, , Peru
Little Rock, Arkansas, United States
Altoona, Pennsylvania, United States
Sapporo Shi, , Japan
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Tg Mures, , Romania
Mobile, Alabama, United States
Humble, Texas, United States
Toronto, , Canada
Moscow, , Russian Federation
Taipei City, , Taiwan
Houma, Louisiana, United States
Beaumont, Texas, United States
Buenos Aires, , Argentina
Catamarca, , Argentina
Blumenau, , Brazil
Sao Paulo, , Brazil
Toronto, Ontario, Canada
Tianjin, , China
Jaromer, , Czechia
Kladno, , Czechia
Nachod, , Czechia
Higashiohmi Shi, , Japan
Ichinomiya Shi, , Japan
Kawasaki Shi, , Japan
Kuki Shi, , Japan
Takasago Shi, , Japan
Utsunomiya Shi, , Japan
Guadalajara, , Mexico
Tijuana, , Mexico
Groningen, , Netherlands
San Isidro, , Peru
Saint Petersburg, , Russian Federation
Sanlúcar De Barrameda (Cádiz), , Spain
Villamartín (Cádiz), , Spain
Sapporo Shi, , Japan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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