Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Launched by ASTRAZENECA · Mar 6, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the effects of a combination treatment called balcinrenone and dapagliflozin for patients who have heart failure and kidney problems. The goal is to see how well this treatment can help reduce serious heart-related issues and improve overall health in people who have recently experienced heart failure symptoms. The study is open to adults aged 18 and older who have a documented diagnosis of heart failure and have had a recent heart-related event, like being hospitalized or needing urgent care.
To participate, individuals must meet certain criteria, such as having specific heart function measurements and not currently taking certain medications. Participants will receive either the new combination treatment or dapagliflozin alone, along with their usual heart failure care. The trial is currently recruiting participants, and those who join will be monitored closely to assess the treatment's effectiveness and safety. This study is important because it may provide new insights into better managing heart failure, especially in patients with kidney difficulties.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years
- • Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
- • Having had a recent HF event within 6 months (hospitalization or urgent visit)
- • Have a LVEF value from an assessment within the last 12 months
- • Managed with SoC therapy for HF and renal impairment according to local guidelines
- • NT-proBNP must be \>300 pg/mL (\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
- • Not taking an MRA
- • An eGFR ≥ 20 to \< 60 mL/min/1.73 m2
- • Serum/plasma potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L
- Exclusion Criteria:
- • Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
- • Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or planned to undergo any of these operations
- • History of hypertrophic obstructive cardiomyopathy
- • Complex congenital heart disease or severe uncorrected primary valvular disease
- • Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- • Systolic BP \< 100 mmHg, or symptomatic hypotension within the past 24 hours
- • Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
- • Type 1 diabetes mellitus
- • Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
- • Hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT \>3 × ULN; or TBL \> 2 × ULN at time of screening
- • Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
- • Treatment with strong or moderate CYP3A4 inhibitor or inducer
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
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Montpellier Cedex, , France
Jacksonville, Florida, United States
Shreveport, Louisiana, United States
Memphis, Tennessee, United States
Fort Lauderdale, Florida, United States
Antofagasta, , Chile
Székesfehérvár, , Hungary
Pune, , India
Nitra, , Slovakia
A Coruña, , Spain
Aurora, Colorado, United States
Tacoma, Washington, United States
Little Rock, Arkansas, United States
Wheat Ridge, Colorado, United States
San Antonio, Texas, United States
Birmingham, Alabama, United States
Encinitas, California, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Gainesville, Florida, United States
Charlotte, North Carolina, United States
Caen, , France
Paris, , France
New Orleans, Louisiana, United States
Plovdiv, , Bulgaria
Barcelona, , Spain
Graz, , Austria
Salzburg, , Austria
Wien, , Austria
Greenfield Park, Quebec, Canada
Helsinki, , Finland
Tampere, , Finland
Strasbourg, , France
Toulouse, , France
Regensburg, , Germany
Bari, , Italy
Huntsville, Alabama, United States
Chicago, Illinois, United States
Orange, California, United States
Alexandria, Louisiana, United States
Gdańsk, , Poland
Los Angeles, California, United States
Miami, Florida, United States
Safety Harbor, Florida, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Columbia, Missouri, United States
Lincoln, Nebraska, United States
New York, New York, United States
Hershey, Pennsylvania, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Jackson, Tennessee, United States
Tullahoma, Tennessee, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Haskovo, , Bulgaria
Pleven, , Bulgaria
London, Ontario, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Praha 2, , Czechia
Hamburg, , Germany
Heidelberg, , Germany
Mainz, , Germany
Witten, , Germany
Pavia, , Italy
Amsterdam, , Netherlands
Arnhem, , Netherlands
Zabrze, , Poland
Bucuresti, , Romania
Presov, , Slovakia
Stockholm, , Sweden
Uppsala, , Sweden
Barnet, , United Kingdom
Ann Arbor, Michigan, United States
San Diego, California, United States
Pensacola, Florida, United States
Novara, , Italy
Aguascalientes, , Mexico
Boston, Massachusetts, United States
Banska Bystrica, , Slovakia
Nashville, Tennessee, United States
Jackson, Mississippi, United States
Manhasset, New York, United States
Karlstad, , Sweden
Jyväskylä, , Finland
Le Coudray, , France
Freiburg, , Germany
Kaiserslautern, , Germany
Münster, , Germany
Wermsdorf, , Germany
Athens, , Greece
Thessaloniki, , Greece
Firenze, , Italy
Leeuwarden, , Netherlands
Middlesborough, , United Kingdom
La Roche Sur Yon Cedex 9, , France
Gyula, , Hungary
Linz, , Austria
Troy, Michigan, United States
Pinehurst, North Carolina, United States
Wilmington, North Carolina, United States
Beverly Hills, California, United States
Dijon, , France
Frankfurt, , Germany
Tel Aviv, , Israel
Atlanta, Georgia, United States
Miami Lakes, Florida, United States
Culiacán, , Mexico
Kansas City, Missouri, United States
Concord, , Australia
Torreon, , Mexico
Johannesburg, , South Africa
Chiang Mai, , Thailand
Budapest, , Hungary
Kecskemét, , Hungary
Valencia, , Spain
Bucaramanga, , Colombia
Rostock, , Germany
Nahariya, , Israel
Madrid, , Spain
Uzhhorod, , Ukraine
Stony Brook, New York, United States
Clearwater, Florida, United States
Seattle, Washington, United States
Amarillo, Texas, United States
Buffalo, New York, United States
Newport News, Virginia, United States
Geelong, , Australia
Leipzig, , Germany
Ashkelon, , Israel
Sevilla, , Spain
Warszawa, , Poland
Muncie, Indiana, United States
North Las Vegas, Nevada, United States
Staten Island, New York, United States
Oklahoma City, Oklahoma, United States
Providence, Rhode Island, United States
El Paso, Texas, United States
Tyler, Texas, United States
Beijing, , China
Shanghai, , China
Cebu City, , Philippines
Manila, , Philippines
Quezon City, , Philippines
Rzeszow, , Poland
Bloemfontein, , South Africa
Taichung, , Taiwan
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Rennes Cedex 9, , France
Mexico, , Mexico
Chihuahua, , Mexico
Bucharest, , Romania
Waterloo, Iowa, United States
Rimavska Sobota, , Slovakia
Iasi, , Romania
Zlin, , Czechia
Kosice, , Slovakia
Munster, Indiana, United States
Sao Paulo, , Brazil
Vancouver, British Columbia, Canada
Nantes Cedex 1, , France
Majadahonda, , Spain
Palm Beach Gardens, Florida, United States
Cona, , Italy
Bratislava, , Slovakia
Phoenix, Arizona, United States
Fukuoka Shi, , Japan
Seoul, , Korea, Republic Of
Newport Beach, California, United States
Redding, California, United States
Thousand Oaks, California, United States
Elkhart, Indiana, United States
Greensboro, North Carolina, United States
Abington, Pennsylvania, United States
Mansfield, Texas, United States
Iloilo City, , Philippines
Bangkok, , Thailand
Lincoln, Nebraska, United States
Sydney, Nova Scotia, Canada
Strasbourg Cedex, , France
Portsmouth, , United Kingdom
Turku, , Finland
Rapid City, South Dakota, United States
San Miguel De Tucuman, , Argentina
Clayton, , Australia
Curitiba, , Brazil
Sliven, , Bulgaria
New Westminster, British Columbia, Canada
Cambridge, Ontario, Canada
Nanjing, , China
Xian, , China
Bogotá, , Colombia
Svitavy, , Czechia
Bad Nauheim, , Germany
Balatonfüred, , Hungary
Busan, , Korea, Republic Of
Kota Samarahan, , Malaysia
Sungai Buloh, , Malaysia
Guadalajara, , Mexico
Hardenberg, , Netherlands
Kosice, , Slovakia
Centurion, , South Africa
Durban, , South Africa
Parktown, , South Africa
Somerset West, , South Africa
Soweto, , South Africa
Changhua, , Taiwan
Kaohsiung, , Taiwan
Sheffield, , United Kingdom
Salt Lake City, Utah, United States
Poitiers, , France
San Francisco, California, United States
Caen Cedex 9, , France
Langen, , Germany
Creteil, , France
Izmir, , Turkey
New Windsor, New York, United States
Ypsilanti, Michigan, United States
Camp Hill, Pennsylvania, United States
Jackson, Tennessee, United States
Houston, Texas, United States
Oshawa, Ontario, Canada
Slany, , Czechia
Reims, , France
Rockville, Maryland, United States
Chengdu, , China
Wuhan, , China
Veracruz, , Mexico
Chicoutimi, Quebec, Canada
Somerset, New Jersey, United States
Airdrie, , United Kingdom
Osaka Shi, , Japan
Seongnam Si, , Korea, Republic Of
Martin, , Slovakia
West Hills, California, United States
Flint, Michigan, United States
Leverkusen, , Germany
Gwangju, , Korea, Republic Of
London, , United Kingdom
Brasov, , Romania
Montpellier, , France
Rouen, , France
Bergamo, , Italy
Toruń, , Poland
Limoges, , France
Covina, California, United States
Alexander City, Alabama, United States
Springfield, Ohio, United States
Houston, Texas, United States
Odessa, Texas, United States
Cordoba, , Argentina
Santa Fe, , Argentina
Botevgrad, , Bulgaria
Dupnitsa, , Bulgaria
Kozloduy, , Bulgaria
Montréal, Quebec, Canada
Jinan, , China
Kasuga Shi, , Japan
Uji Shi, , Japan
Busan, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Culiacan, , Mexico
Monterey, , Mexico
Xalapa, , Mexico
Groningen, , Netherlands
Pasig City, , Philippines
Chrzanów, , Poland
Lublin, , Poland
Worcester, , South Africa
Pathumthani, , Thailand
Kyiv, , Ukraine
Vinnytsia, , Ukraine
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Tucker, Georgia, United States
Falls Church, Virginia, United States
Mar Del Plata, , Argentina
Winnipeg, Manitoba, Canada
Nanjing, , China
Dresden, , Germany
Catania, , Italy
San Giovanni Rotondo, , Italy
Beppu Shi, , Japan
Kishiwada Shi, , Japan
Bucheon Si, , Korea, Republic Of
Tijuana, , Mexico
Taguig City, , Philippines
Gdynia, , Poland
Ostrów Mazowiecka, , Poland
Tarnów, , Poland
Stockholm, , Sweden
Bursa, , Turkey
Istanbul, , Turkey
Ivano Frankivsk, , Ukraine
Ho Chi Minh, , Vietnam
Wakefield, , United Kingdom
Santa Ana, California, United States
Hazel Crest, Illinois, United States
Córdoba, , Argentina
Peterborough, Ontario, Canada
Goes, , Netherlands
Olsztyn, , Poland
Nove Zamky, , Slovakia
Jönköping, , Sweden
Kocaeli, , Turkey
Sivas, , Turkey
London, , United Kingdom
Chermside, , Australia
Nanjing, , China
Saint Augustine, Florida, United States
Coburg, , Germany
Tours Cedex 9, , France
Yangzhou, , China
Taoyuan, , Taiwan
Beer Sheva, , Israel
Exeter, , United Kingdom
North Chicago, Illinois, United States
Maumee, Ohio, United States
Cypress, Texas, United States
Fairhope, Alabama, United States
Bradenton, Florida, United States
Saint Stefan/Stainz, , Austria
São Paulo, , Brazil
Waterloo, Ontario, Canada
St Jean Sur Richelieu, Quebec, Canada
Pingxiang, , China
Armenia, , Colombia
Barranquilla, , Colombia
Ceska Lipa, , Czechia
Louny, , Czechia
Montauban, , France
Papenburg, , Germany
Pécs, , Hungary
New Delhi, , India
Fukui Shi, , Japan
Iwakuni Shi, , Japan
Kawanishi Shi, , Japan
Sanyoonoda Shi, , Japan
Daegu, , Korea, Republic Of
Wonju Si, , Korea, Republic Of
Morelia, , Mexico
Querétaro, , Mexico
Emmen, , Netherlands
Bielsko Biała, , Poland
Rzeszów, , Poland
Tychy, , Poland
Dammam, , Saudi Arabia
Uppsala, , Sweden
New Taipei City, , Taiwan
Hat Yai, , Thailand
Naimuang, , Thailand
Antalya, , Turkey
High Wycombe, , United Kingdom
Hochiminh, , Vietnam
Incheon, , Korea, Republic Of
La Tronche, , France
Chicago, Illinois, United States
Augusta, Maine, United States
Guangzhou, , China
Winfield, Illinois, United States
Catanzaro, , Italy
Budapest, , Hungary
Fujisawa Shi, , Japan
Toshima Ku, , Japan
Nagoya Shi, , Japan
Blacktown, , Australia
Changchun, , China
Guangzhou, , China
Hohhot, , China
Lanzhou, , China
Békéscsaba, , Hungary
Brescia, , Italy
Hakusan Shi, , Japan
Tsuchiura Shi, , Japan
Dresden, , Germany
Frankston, , Australia
Bunkyo Ku, , Japan
Taipei City, , Taiwan
Kasugai Shi, , Japan
Ueda Shi, , Japan
Chertsey, , United Kingdom
Changsha, , China
Hai Phong, , Vietnam
Mckinney, Texas, United States
Florencio Varela, , Argentina
Bogotá, , Colombia
Khon Kaen, , Thailand
Can Tho, , Vietnam
Yilan, , Taiwan
Ha Noi, , Vietnam
San Francisco, California, United States
Cali, , Colombia
Hyderabad, , India
Vijayawada, , India
Daejeon, , Korea, Republic Of
Uijeongbu Si, , Korea, Republic Of
Bellavista, , Peru
New Taipei, , Taiwan
Taipei, , Taiwan
Hue, , Vietnam
Haifa, , Israel
Maebashi Shi, , Japan
Barranquilla, , Colombia
Mexico City, , Mexico
Los Angeles, California, United States
Panorama, , South Africa
Ternopil, , Ukraine
Pearland, Texas, United States
Parow, , South Africa
Anyang Si, , Korea, Republic Of
Lugo, , Spain
Chapel Hill, North Carolina, United States
Richmond, Indiana, United States
Kfar Saba, , Israel
Fukuoka Shi, , Japan
Matsumoto Shi, , Japan
Toulon, , France
Yokohama Shi, , Japan
Nanchang, , China
Bogota, , Colombia
Temuco, , Chile
Uwajima Shi, , Japan
Bronx, New York, United States
Lancaster, South Carolina, United States
Sherman, Texas, United States
Cairns, , Australia
Baotou, , China
Linhai, , China
Porto Alegre, , Brazil
Tiberias, , Israel
Hangzhou, , China
Kure Shi, , Japan
Las Pinas City, , Philippines
Harefield, , United Kingdom
Mönchengladbach, , Germany
St. Pölten, , Austria
Davao City, , Philippines
Orosháza, , Hungary
West Monroe, Louisiana, United States
North Vancouver, British Columbia, Canada
Valenciennes, , France
Kazimierza Wielka, , Poland
Sunderland, , United Kingdom
Cluj Napoca, , Romania
Xuzhou, , China
Hengyang, , China
Shenzhen, , China
Esperanza, , Argentina
Campinas, , Brazil
Newmarket, Ontario, Canada
North York, Ontario, Canada
Oakville, Ontario, Canada
Chifeng, , China
Belagavi, , India
Karamsad, , India
Kitakyusyu Shi, , Japan
Mito Shi, , Japan
Sagamihara Shi, , Japan
Kraków, , Poland
Clydebank, , United Kingdom
Kobe Shi, , Japan
Mazatlán, , Mexico
Marikina, , Philippines
Kent, , United Kingdom
Changsha, , China
Jining, , China
Eskisehir, , Turkey
México, , Mexico
Fall River, Massachusetts, United States
Allen, Texas, United States
Kanazawa Shi, , Japan
Ar Riyāḑ, , Saudi Arabia
Rio De Janeiro, , Brazil
Remscheid, , Germany
Caba, , Argentina
Blumenau, , Brazil
Toronto, Ontario, Canada
Jaromer, , Czechia
Tijuana, , Mexico
Riyadh, , Saudi Arabia
Ciudad De Buenos Aires, , Argentina
Glenview, Illinois, United States
Adana, , Turkey
San Luis Potosí, , Mexico
Lund, , Sweden
Canberra, , Australia
Beziers, , France
Manipal, , India
Goiania, , Brazil
Knoxville, Tennessee, United States
Saitama Shi, , Japan
Altamonte Springs, Florida, United States
Afula, , Israel
Jeddah, , Saudi Arabia
Göteborg, , Sweden
Ankara, , Turkey
Buenos Aires, , Argentina
Urumqi, , China
Be'er Ya'akov, , Israel
Yangsan Si, , Korea, Republic Of
Coimbatore, , India
Biała Podlaska, , Poland
Västerås, , Sweden
Cambridge, , United Kingdom
Lincoln, , United Kingdom
Hagen, , Germany
Kawaguchi, , Japan
Brezno, , Slovakia
Hódmezővásárhely, , Hungary
Oita Shi, , Japan
Piura, , Peru
Murdoch, , Australia
Plzen Bory, , Czechia
Milan, , Italy
Cape Town, , South Africa
Aracaju, , Brazil
Kuantan, , Malaysia
Hengyang, , China
Poznań, , Poland
Bydgoszcz, , Poland
Brasilia, , Brazil
Trois Rivières, Quebec, Canada
Broumov, , Czechia
Kütahya, , Turkey
Sanya, , China
Ajmer, , India
Rosario, , Argentina
Saint Paul, Minnesota, United States
Angeles City, , Philippines
Cuauhtémoc, , Mexico
Roxas City, , Philippines
Shenyang, , China
Elsterwerda, , Germany
Harbin, , China
Ahmedabad, , India
West San Juan City, , Philippines
Yung Kang City, , Taiwan
Toyota City, , Japan
Kajang, , Malaysia
Kanpur, , India
Valdivia, , Chile
Xi'an, , China
Hochiminh City, , Vietnam
Dinar, , Turkey
Jung Gu, , Korea, Republic Of
Jerusalem, , Israel
Kuala Terengganu, , Malaysia
Kolkata, , India
łódź, , Poland
Petah Tikva, , Israel
Braunau Am Inn, , Austria
Mysuru, , India
Acquaviva Delle Fonti, , Italy
Svidník, , Slovakia
Campina Grande Do Sul, , Brazil
Linhai, , China
Da Nang, , Vietnam
Liaocheng, , China
Bronx, New York, United States
Dearborn, Michigan, United States
Rionegro, , Colombia
Hammond, Indiana, United States
Manadaluyong City, , Philippines
Völklingen, , Germany
Myjava, , Slovakia
Vista, California, United States
Katy, Texas, United States
Victoria, , Chile
Medellin, , Colombia
Metepec, , Mexico
Lima, , Peru
Ladson, South Carolina, United States
Wichita, Kansas, United States
Heze, , China
Horsham, Pennsylvania, United States
Memphis, Tennessee, United States
Corrientes, , Argentina
Ganadero Baigorria, , Argentina
Santiago, , Chile
Cali, , Colombia
Brno, , Czechia
Plzen, , Czechia
Prerov, , Czechia
Ustí Nad Labem, , Czechia
Bron, , France
Orleans, , France
Bechhofen, , Germany
Bernau Bei Berlin, , Germany
Chemnitz, , Germany
Köln, , Germany
Dragana, , Greece
Heraklio, , Greece
Cortona, , Italy
Fukutsu Shi, , Japan
Himeji, , Japan
Moriyama Shi, , Japan
Sakai Shi, , Japan
Sakata City, , Japan
Kota Kinabalu, , Malaysia
Kuala Lumpur, , Malaysia
Mabalacat, , Philippines
Białystok, , Poland
Kędzierzyn Koźle, , Poland
Piekary śląskie, , Poland
Szczecin, , Poland
Targu Mures, , Romania
Timisoara, , Romania
Timișoara, , Romania
Považská Bystrica, , Slovakia
Prešov, , Slovakia
Alingsås, , Sweden
Helsingborg, , Sweden
Merkez, , Turkey
Mugla, , Turkey
Hastings, , United Kingdom
King's Lynn, , United Kingdom
Nanchong, , China
Xianyang, , China
Sao Jose Dos Campos, , Brazil
Teresina, , Brazil
Uberlândia, , Brazil
Punta Arenas, , Chile
Holon, , Israel
Kanonji Shi, , Japan
Kochi Shi, , Japan
Saitama Shi, , Japan
Yanagawa Shi, , Japan
Mexico, , Mexico
Molndal, , Sweden
Bangalore, , India
Delhi, , India
Hyderabad, , India
Nagpur, , India
Makati, , Philippines
Pretoria, , South Africa
Sevilla, , Spain
Piedecuesta, , Colombia
Chernivtsі, , Ukraine
ústí Nad Labem, , Czechia
Jönköping, , Sweden
Vasteras, , Sweden
Jonkoping, , Sweden
Quzhou, , China
Wrocław, , Poland
Zhytomyr, , Ukraine
Katowice, , Poland
Warszawa, , Poland
Taichung City, , Taiwan
Hamilton, Ontario, Canada
Zhangjiakou, , China
Buenos Aires, , Argentina
Svitavy, , Czechia
Poznań, , Poland
Iasi, , Romania
Satu Mare, , Romania
Olsztyn, , Poland
North Tamworth, , Australia
Saint Charles Borromee, Quebec, Canada
Gwangmyeong Si, , Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported