A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
Launched by BOEHRINGER INGELHEIM · Apr 17, 2025
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a medication called vicadrostat, when combined with another medication called empagliflozin, can help people with heart failure. Heart failure occurs when the heart has difficulty pumping blood effectively, and this trial specifically focuses on adults whose heart function is weakened (measured by a left ventricular ejection fraction of less than 40%). To participate, individuals must be at least 18 years old and have been diagnosed with chronic heart failure for at least three months.
Participants in the trial will be randomly assigned to two groups: one group will receive the combination of vicadrostat and empagliflozin, while the other group will receive a placebo (a pill that looks like the medication but contains no active ingredients) along with empagliflozin. The study will last between one and about 3.5 years, during which participants will take the medications daily and continue their regular heart failure treatments. They will attend regular check-ups, answer questions about their health, and be monitored for any side effects or changes in their heart condition. This research aims to see if the new treatment can improve heart failure symptoms and overall health.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- • 2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- • 3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the protocol.
- • 4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \< 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).
- • 5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory
- • 6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local/international guidelines and judgement of the investigator.
- • Additional inclusion criteria apply.
- Exclusion criteria:
- • 1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.
- • 2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.
- 3. Receiving the following treatments:
- • A direct renin inhibitor (e.g. aliskiren) at Visit 2
- • More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2
- • Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- • Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
- * In case of acute decompensated HF:
- • i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation
- • i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
- • 4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)
- • 5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
- • 6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
- • 7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2
- • 8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Bridgeport, Connecticut, United States
Sudbury, Ontario, Canada
Madrid, , Spain
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Norfolk, Virginia, United States
Jacksonville, Florida, United States
Bristol, , United Kingdom
Jacksonville, Florida, United States
Madrid, , Spain
Gainesville, Florida, United States
New York, New York, United States
Rozzano, , Italy
Hannover, , Germany
Valencia, , Spain
London, , United Kingdom
Halifax, , United Kingdom
Valencia, , Spain
Montgomery, Alabama, United States
Munster, Indiana, United States
Houston, Texas, United States
Eindhoven, , Netherlands
Valencia, , Spain
Kansas City, Missouri, United States
Barcelona, , Spain
Madrid, , Spain
Hvidovre, , Denmark
Malaga, , Spain
Erfurt, , Germany
Taipei, , Taiwan
Jinan, , China
Ypsilanti, Michigan, United States
Kaohsiung, , Taiwan
Longview, Texas, United States
Springfield, Illinois, United States
Raleigh, North Carolina, United States
Groningen, , Netherlands
Brandon, Florida, United States
Jacksonville, Florida, United States
Seoul, , Korea, Republic Of
Porto Alegre, , Brazil
Tomball, Texas, United States
Monterrey, , Mexico
Busan, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Pavia, , Italy
Riyadh, , Saudi Arabia
Dendermonde, , Belgium
Brno, , Czechia
Beijing, , China
Miami, Florida, United States
Budapest, , Hungary
Miskolc, , Hungary
Braila, , Romania
Holbæk, , Denmark
Jena, , Germany
Regensburg, , Germany
Hammond, Louisiana, United States
Incheon, , Korea, Republic Of
Liège, , Belgium
Wellington, Florida, United States
Taipei, , Taiwan
Worms, , Germany
Seoul, , Korea, Republic Of
Jacksonville, Florida, United States
Gent, , Belgium
Roma, , Italy
Seongnam, , Korea, Republic Of
Barcelona, , Spain
Shenyang, , China
Changchun, , China
Takasaki Shi, , Japan
Porto Alegre, , Brazil
Guangzhou, , China
Nieuwegein, , Netherlands
Wuhan, , China
Busan, , Korea, Republic Of
Changsha, , China
Kiel, , Germany
Statesville, North Carolina, United States
Mosonmagyarovar, , Hungary
Seoul, , Korea, Republic Of
Pancevo, , Serbia
Nis, , Serbia
Seoul, , Korea, Republic Of
Columbus, Georgia, United States
Brasov, , Romania
Napoli, , Italy
Barcelona, , Spain
Arlington Heights, Illinois, United States
West Des Moines, Iowa, United States
Bay City, Michigan, United States
Manalapan, New Jersey, United States
Ramos Mejía, , Argentina
Campina Grande Do Sul, , Brazil
Viña Del Mar, , Chile
Beijing, , China
Nanjing, , China
Shijiazhuang, , China
Wuhan, , China
Aguascalientes, , Mexico
Culiacan, , Mexico
Pisa, , Italy
'S Hertogenbosch, , Netherlands
Nanchang, , China
Dallas, Texas, United States
Genk, , Belgium
Sofia, , Bulgaria
Herlev, , Denmark
Wermsdorf, , Germany
Bucharest, , Romania
Rosario, , Argentina
Beltsville, Maryland, United States
Bridgewater, New Jersey, United States
Slagelse, , Denmark
Zhenjiang, , China
Bardejov, , Slovakia
Jackson, Mississippi, United States
Bahia Blanca, , Argentina
La Plata, , Argentina
Quilmes, , Argentina
Rosario, , Argentina
San Nicolas, , Argentina
Santa Fe, , Argentina
Santiago, , Chile
Guangzhou, , China
Marianske Lazne, , Czechia
Slany, , Czechia
Seoul, , Korea, Republic Of
Tijuana, , Mexico
Bucuresti, , Romania
Villamartin, , Spain
Bergamo, , Italy
Istanbul, , Turkey
Izmir, , Turkey
Taipei City, , Taiwan
Surat, , India
Pilar, , Argentina
Cambridge, Ontario, Canada
Peterborough, Ontario, Canada
Shanghai, , China
Copenhagen Nv, , Denmark
Adana, , Turkey
Richmond, Indiana, United States
Belgrade, , Serbia
Maastricht, , Netherlands
Niska Banja, , Serbia
Elkhart, Indiana, United States
Talcahuano, , Chile
Praha 4, , Czechia
Bad Friedrichshall, , Germany
Bonn, , Germany
Langen, , Germany
Ishikawa, Kanazawa, , Japan
Kanagawa, Fujisawa, , Japan
Kaohsiung, , Taiwan
Saint Louis, Missouri, United States
Cordoba, , Argentina
Kortrijk, , Belgium
Manizales, , Colombia
México, , Mexico
Rosario, , Argentina
Hanoi, , Vietnam
São José Do Rio Preto, , Brazil
Quilmes, , Argentina
La Louvière, , Belgium
Palmetto Bay, Florida, United States
Santiago De Compostela, , Spain
Bergamo, , Italy
Busan, , Korea, Republic Of
Gdynia, , Poland
Wroclaw, , Poland
Ho Chi Minh, , Vietnam
Gaziantep, , Turkey
Mersin, , Turkey
Talca, , Chile
Valencia, , Spain
Seoul, , Korea, Republic Of
Meguro Ku, , Japan
Barcelona, , Spain
Roskilde, , Denmark
Bekescsaba, , Hungary
Banska Bystrica, , Slovakia
Barranquilla, , Colombia
Covina, California, United States
Indianapolis, Indiana, United States
Manassas, Virginia, United States
Ciudad Autonoma Buenos Aires, , Argentina
Cordoba, , Argentina
Salta, , Argentina
San Martin, , Argentina
San Miguel De Tucuman, , Argentina
Villa Luro, , Argentina
Brasília, , Brazil
Brasília, , Brazil
Campinas, , Brazil
Goiânia, , Brazil
Marília, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Vitória, , Brazil
Changsha, , China
Fuzhou, , China
Lanzhou, , China
Tianjin, , China
Brno, , Czechia
Praha 5, , Czechia
Trutnov, , Czechia
Uherske Hradiste, , Czechia
Bangalore, , India
Fukuoka, Chikushino, , Japan
Saitama, Saitama, , Japan
Guadalajara, , Mexico
Bielsko Biala, , Poland
Piaseczno, , Poland
Siedlce, , Poland
Timisoara, , Romania
Ciudad Autonoma Buenos Aires, , Argentina
Oshawa, Ontario, Canada
Praha 10, , Czechia
Copenhagen S, , Denmark
Miskolc, , Hungary
Sofia, , Bulgaria
Erzurum, , Turkey
Fujisawa Shi, , Japan
Haikou, , China
Zwolle, , Netherlands
Shanghai, , China
Sao Paulo, , Brazil
Bydgoszcz, , Poland
Pavia, , Italy
Passo Fundo, , Brazil
Changchun, , China
Patna, , India
Mckinney, Texas, United States
Northridge, California, United States
Winter Park, Florida, United States
Pingxiang, , China
Wilmington, North Carolina, United States
Kumamoto Shi, , Japan
Amsterdam, , Netherlands
Mobile, Alabama, United States
Budapest, , Hungary
Rapid City, South Dakota, United States
Chennai, , India
Belgrade, , Serbia
Bogota, , Colombia
Tachikawa Shi, , Japan
Toyota Shi, , Japan
Dalian, , China
Mckinney, Texas, United States
Daytona Beach, Florida, United States
Amarillo, Texas, United States
Nanning, , China
Istanbul, , Turkey
Chongqing, , China
Saint Augustine, Florida, United States
Skórzewo, , Poland
Louny, , Czechia
Cordoba, , Argentina
Cordoba, , Argentina
Targu Mures, , Romania
Timisoara, , Romania
Kragujevac, , Serbia
Zajecar, , Serbia
Sofia, , Bulgaria
Queretaro, , Mexico
Jena, , Germany
Santa Marta, , Colombia
Ho Chi Minh City, , Vietnam
Chengdu, , China
Port Charlotte, Florida, United States
Rio De Janeiro, , Brazil
Taichung, , Taiwan
Ome Shi, , Japan
Xinxiang, , China
Bydgoszcz, , Poland
Budapest, , Hungary
Budapest, , Hungary
Chichester, , United Kingdom
Warszawa, , Poland
Kure, , Japan
Veliko Tarnovo, , Bulgaria
Kumamoto Shi, , Japan
Dallas, Texas, United States
Cali, , Colombia
Porto Alegre, , Brazil
Luoyang, , China
Culiacan, , Mexico
Zalaegerszeg, , Hungary
Lucenec, , Slovakia
Luoyang, , China
Rzeszow, , Poland
Cluj Napoca, , Romania
Himeji Shi, , Japan
Osaka Shi, , Japan
Sofia, , Bulgaria
Suita Shi, , Japan
Osaka Shi, , Japan
San Miguel De Tucuman, , Argentina
Kolkata, , India
Kutahya, , Turkey
Kardzhali, , Bulgaria
Budapest, , Hungary
Aurangabad, , India
Matsuyama Shi, , Japan
Monterrey, , Mexico
Hanoi, , Vietnam
Taiyuan, , China
Linfen, , China
Kraków, , Poland
Sofia, , Bulgaria
Caxias Do Sul, , Brazil
Szekszard, , Hungary
Waco, Texas, United States
Ningbo, , China
Kyustendil, , Bulgaria
Yueyang, , China
Santiago, , Chile
Amagasaki Shi, , Japan
Xuancheng, , China
Dammam, , Saudi Arabia
Olomouc, , Czechia
Johns Creek, Georgia, United States
Natal, , Brazil
Lublin, , Poland
Foshan, , China
Warsaw, , Poland
Hiratsuka Shi, , Japan
Baltimore, Maryland, United States
Lake Forest, California, United States
Sofia, , Bulgaria
Kosice, , Slovakia
Pleven, , Bulgaria
Jiangmen, , China
Belo Horizonte, , Brazil
Campo Largo, , Brazil
Sofia, , Bulgaria
Nanjing, , China
Vishakhapatnam, , India
Ciudad Autonoma Buenos Aires, , Argentina
Rio De Janeiro, , Brazil
Pembroke Pines, Florida, United States
Wonju Si, Gangwon State, , Korea, Republic Of
Oradea, , Romania
Tianjin, , China
Gabrovo, , Bulgaria
Staszow, , Poland
Chenzhou, , China
Riyadh, , Saudi Arabia
Merrillville, Indiana, United States
Surat, , India
Mar Del Plata, , Argentina
Libertyville, Illinois, United States
Park Ridge, Illinois, United States
Wichita, Kansas, United States
Amarillo, Texas, United States
Shenyang, , China
Hamilton, Ontario, Canada
Lodz, , Poland
Lublin, , Poland
Wesley Chapel, Florida, United States
Mito Shi, , Japan
Kobe Shi, , Japan
Ankara, , Turkey
Hamada Shi, , Japan
Praha, , Czechia
Pleven, , Bulgaria
Sarnia, Ontario, Canada
St. Jean Sur Richelieu, , Canada
Brandys Nad Labem, , Czechia
Budapest, , Hungary
Kamakura Shi, , Japan
Kraków, , Poland
Armenia, , Colombia
Ciudad Autonoma Buenos Aires, , Argentina
Hallandale Beach, Florida, United States
Shreveport, Louisiana, United States
Exeter, , United Kingdom
Banska Bystrica, , Slovakia
Trois Rivieres, Quebec, Canada
Pitesti, , Romania
Ho Chi Minh, , Vietnam
Chicago, Illinois, United States
Nashik, , India
Budapest, , Hungary
Foggia, , Italy
Guiyang, , China
Ningbo, , China
Bardejov, , Slovakia
Kosice, , Slovakia
Ciudad Autonoma Buenos Aires, , Argentina
Coronel Suarez, , Argentina
Córdoba, , Argentina
Curitiba, , Brazil
Porto Alegre, , Brazil
Santo Andre, , Brazil
Santo Andre, , Brazil
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Temuco, , Chile
Changchun, , China
Changde City, , China
Deyang, , China
Guangzhou, , China
Harbin, , China
Nanchang, , China
Nanyang, , China
Panjin, , China
Shanghai, , China
Shenzhen, , China
Xi An, , China
Yinchuan, , China
Yuncheng, , China
Zhangjiakoou, , China
Cartagena, , Colombia
Brandýs Nad Labem, , Czechia
Chrudim, , Czechia
Praha 1, , Czechia
Neuwied, , Germany
Pecs, , Hungary
Bikaner, , India
Chennai, , India
Gurgaon, , India
Iwakuni Shi, , Japan
Kanonji Shi, , Japan
Kishiwada Shi, , Japan
Matsuyama Shi, , Japan
Miura Gun, , Japan
Nakano Shi, , Japan
Tomakomai Shi, , Japan
Irapuato, , Mexico
Mazatlan, , Mexico
Legnica, , Poland
Skierniewice, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Zarow, , Poland
Balotesti, , Romania
Cluj Napoca, , Romania
Targu Mures, , Romania
Smederevo, , Serbia
Ho Chi Minh, , Vietnam
Roma, , Italy
Mississauga, Ontario, Canada
Wermsdorf, , Germany
Bahia Blanca, , Argentina
Caba, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Rosario, , Argentina
Rosario, , Argentina
Salta, , Argentina
San Miguel De Tucuman, , Argentina
San Miguel De Tucuman, , Argentina
Santa Fe, , Argentina
Santa Fe, , Argentina
Gilly, , Belgium
Belo Horizonte, , Brazil
Brasília, , Brazil
Campinas, , Brazil
Campinas, , Brazil
Goiania, , Brazil
Minas Gerais, , Brazil
Ribeirão Preto, , Brazil
Rio De Janeiro, , Brazil
Salvador, , Brazil
São José Do Rio Preto, , Brazil
São José Dos Campos, , Brazil
Uberlandia, , Brazil
Kitchener, Ontario, Canada
Oakville, Ontario, Canada
St. Catharines, Ontario, Canada
Brossard, Quebec, Canada
Guangzhou, , China
Zhengzhou, , China
Barranquilla, , Colombia
Bogota, , Colombia
Bogota, , Colombia
Aabenraa, , Denmark
Bamberg, , Germany
Bonn, , Germany
Coburg, , Germany
Lüneburg, , Germany
Papenburg, , Germany
Torreon, , Mexico
Bydgoszcz, , Poland
Gdansk, , Poland
Krakow, , Poland
Plock, , Poland
Sremska Kamenica, , Serbia
Bratislava, , Slovakia
Bratislava, , Slovakia
Bratislava, , Slovakia
Brezno, , Slovakia
Kosice, , Slovakia
Kosice, , Slovakia
Lucenec, , Slovakia
Martin, , Slovakia
Nitra, , Slovakia
Nove Zamky, , Slovakia
Sanlucar De Barrameda, , Spain
Torrejón De Ardoz, , Spain
Taipei, , Taiwan
Litovel, , Czechia
New Delhi, , India
Sendai Shi, , Japan
Linfen, , China
México, , Mexico
Marion, Ohio, United States
Greenville, South Carolina, United States
Fort Worth, Texas, United States
Chongqing, , China
Bilovec, , Czechia
Jaromer, , Czechia
Al Ahsa, , Saudi Arabia
Kosice, , Slovakia
Kosice, , Slovakia
Martin, , Slovakia
Kanagawa, Miura Gun, , Japan
Matsumoto Shi, , Japan
Suita Shi, , Japan
Tokushima Shi, , Japan
Thousand Oaks, California, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Farmington Hills, Michigan, United States
Omaha, Nebraska, United States
New York, New York, United States
Lenoir, North Carolina, United States
Beaumont, Texas, United States
Irving, Texas, United States
Richmond, Texas, United States
Burgas, , Bulgaria
Dimitrovgrad, , Bulgaria
Pernik, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Asahi Shi, , Japan
Chikushino Shi, , Japan
Hachioji Shi, , Japan
Hamamatsu Shi, , Japan
Kasugai Shi, , Japan
Matsudo Shi, , Japan
Miyagi, Sendai, , Japan
Nagasaki, , Japan
Okayama, Okayama, , Japan
Omura Shi, , Japan
Sapporo Shi, , Japan
Tanabe Shi, , Japan
Ueda Shi, , Japan
Yokohama Shi, , Japan
Warszawa, , Poland
Brasov, , Romania
Craiova, , Romania
Eskisehir, , Turkey
Malatya, , Turkey
Uskudar / Istanbul, , Turkey
Ha Noi, , Vietnam
Ho Chi Minh City, , Vietnam
Ho Chi Minh, , Vietnam
Ho Chi Minh, , Vietnam
Manizales, , Colombia
San Miguel De Tucuman, , Argentina
Yambol, , Bulgaria
Cambridge, Ontario, Canada
Changsha, , China
Nanyang, , China
Tai'an, , China
Taiyuan, , China
Wallerfing, , Germany
Kochi, , India
Nashik, , India
Hitachinaka Shi, , Japan
Kasama Shi, , Japan
Kawaguchi Shi, , Japan
Nagasaki, Nagasaki, , Japan
Nagoya Shi, , Japan
Sakai Shi, , Japan
Shimonoseki Shi, , Japan
Baia Mare, , Romania
Suceava, , Romania
Targu Mures, , Romania
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported