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 May 19, 2025
Not yet 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
Sudbury, Ontario, Canada
Madrid, , Spain
Kansas City, Missouri, United States
Bristol, , United Kingdom
Madrid, , Spain
Rozzano, , Italy
Hannover, , Germany
Valencia, , Spain
London, , United Kingdom
Halifax, , United Kingdom
Valencia, , Spain
Munster, Indiana, United States
Eindhoven, , Netherlands
Valencia, , Spain
Barcelona, , Spain
Madrid, , Spain
Hvidovre, , Denmark
Malaga, , Spain
Erfurt, , Germany
Taipei, , Taiwan
Jinan, , China
Kaohsiung, , Taiwan
Groningen, , Netherlands
Jacksonville, Florida, United States
Seoul, , Korea, Republic Of
Porto Alegre, , Brazil
Monterrey, , Mexico
Busan, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Pavia, , Italy
Riyadh, , Saudi Arabia
Dendermonde, , Belgium
Brno, , Czechia
Beijing, , China
Budapest, , Hungary
Miskolc, , Hungary
Holbæk, , Denmark
Jena, , Germany
Regensburg, , Germany
Incheon, , Korea, Republic Of
Liège, , Belgium
Wellington, Florida, United States
Taipei, , Taiwan
Worms, , Germany
Seoul, , Korea, Republic Of
Gent, , Belgium
Roma, , Italy
Seongnam, , Korea, Republic Of
Barcelona, , Spain
Changchun, , China
Porto Alegre, , Brazil
Guangzhou, , China
Nieuwegein, , Netherlands
Busan, , Korea, Republic Of
Kiel, , Germany
Mosonmagyarovar, , Hungary
Seoul, , Korea, Republic Of
Pancevo, , Serbia
Nis, , Serbia
Seoul, , Korea, Republic Of
Columbus, Georgia, United States
Napoli, , Italy
Barcelona, , Spain
Manalapan, New Jersey, United States
Ramos Mejía, , Argentina
Campina Grande Do Sul, , Brazil
Wuhan, , China
Aguascalientes, , Mexico
Culiacan, , Mexico
Pisa, , Italy
'S Hertogenbosch, , Netherlands
Dallas, Texas, United States
Genk, , Belgium
Herlev, , Denmark
Wermsdorf, , Germany
Rosario, , Argentina
Bridgewater, New Jersey, United States
Slagelse, , Denmark
Zhenjiang, , China
Bardejov, , Slovakia
Bahia Blanca, , Argentina
La Plata, , Argentina
Quilmes, , Argentina
Rosario, , Argentina
San Nicolas, , Argentina
Santa Fe, , Argentina
Guangzhou, , China
Marianske Lazne, , Czechia
Slany, , Czechia
Seoul, , Korea, Republic Of
Tijuana, , Mexico
Villamartin, , Spain
Bergamo, , Italy
Taipei City, , Taiwan
Pilar, , Argentina
Cambridge, Ontario, Canada
Peterborough, Ontario, Canada
Shanghai, , China
Copenhagen Nv, , Denmark
Belgrade, , Serbia
Maastricht, , Netherlands
Niska Banja, , Serbia
Praha 4, , Czechia
Bad Friedrichshall, , Germany
Bonn, , Germany
Langen, , Germany
Kaohsiung, , Taiwan
Cordoba, , Argentina
Kortrijk, , Belgium
Manizales, , Colombia
México, , Mexico
Rosario, , Argentina
São José Do Rio Preto, , Brazil
Quilmes, , Argentina
La Louvière, , Belgium
Santiago De Compostela, , Spain
Bergamo, , Italy
Busan, , Korea, Republic Of
Gdynia, , Poland
Wroclaw, , Poland
Valencia, , Spain
Seoul, , Korea, Republic Of
Barcelona, , Spain
Roskilde, , Denmark
Bekescsaba, , Hungary
Banska Bystrica, , Slovakia
Barranquilla, , Colombia
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
Lanzhou, , China
Brno, , Czechia
Praha 5, , Czechia
Trutnov, , Czechia
Uherske Hradiste, , Czechia
Guadalajara, , Mexico
Bielsko Biala, , Poland
Piaseczno, , Poland
Siedlce, , Poland
Ciudad Autonoma Buenos Aires, , Argentina
Oshawa, Ontario, Canada
Praha 10, , Czechia
Copenhagen S, , Denmark
Miskolc, , Hungary
Zwolle, , Netherlands
Shanghai, , China
Sao Paulo, , Brazil
Bydgoszcz, , Poland
Pavia, , Italy
Passo Fundo, , Brazil
Changchun, , China
Mckinney, Texas, United States
Winter Park, Florida, United States
Amsterdam, , Netherlands
Mobile, Alabama, United States
Budapest, , Hungary
Rapid City, South Dakota, United States
Chennai, , India
Belgrade, , Serbia
Bogota, , Colombia
Dalian, , China
Mckinney, Texas, United States
Daytona Beach, Florida, United States
Amarillo, Texas, United States
Nanning, , China
Skórzewo, , Poland
Louny, , Czechia
Cordoba, , Argentina
Cordoba, , Argentina
Kragujevac, , Serbia
Zajecar, , Serbia
Queretaro, , Mexico
Jena, , Germany
Santa Marta, , Colombia
Chengdu, , China
Port Charlotte, Florida, United States
Rio De Janeiro, , Brazil
Taichung, , Taiwan
Bydgoszcz, , Poland
Budapest, , Hungary
Budapest, , Hungary
Chichester, , United Kingdom
Warszawa, , Poland
Dallas, Texas, United States
Cali, , Colombia
Porto Alegre, , Brazil
Luoyang, , China
Culiacan, , Mexico
Zalaegerszeg, , Hungary
Lucenec, , Slovakia
Rzeszow, , Poland
San Miguel De Tucuman, , Argentina
Kolkata, , India
Budapest, , Hungary
Monterrey, , Mexico
Kraków, , Poland
Caxias Do Sul, , Brazil
Szekszard, , Hungary
Xuancheng, , China
Dammam, , Saudi Arabia
Olomouc, , Czechia
Johns Creek, Georgia, United States
Natal, , Brazil
Lublin, , Poland
Foshan, , China
Warsaw, , Poland
Lake Forest, California, United States
Kosice, , Slovakia
Jiangmen, , China
Belo Horizonte, , Brazil
Campo Largo, , Brazil
Nanjing, , China
Vishakhapatnam, , India
Ciudad Autonoma Buenos Aires, , Argentina
Rio De Janeiro, , Brazil
Wonju Si, Gangwon State, , Korea, Republic Of
Staszow, , Poland
Chenzhou, , China
Riyadh, , Saudi Arabia
Merrillville, Indiana, United States
Mar Del Plata, , Argentina
Amarillo, Texas, United States
Shenyang, , China
Hamilton, Ontario, Canada
Lodz, , Poland
Lublin, , Poland
Wesley Chapel, Florida, United States
Praha, , Czechia
Sarnia, Ontario, Canada
St. Jean Sur Richelieu, , Canada
Brandys Nad Labem, , Czechia
Budapest, , Hungary
Kraków, , Poland
Armenia, , Colombia
Ciudad Autonoma Buenos Aires, , Argentina
Hallandale Beach, Florida, United States
Exeter, , United Kingdom
Banska Bystrica, , Slovakia
Trois Rivieres, Quebec, Canada
Budapest, , Hungary
Foggia, , Italy
Guiyang, , 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
Changde City, , China
Deyang, , China
Guangzhou, , China
Nanchang, , China
Nanyang, , China
Panjin, , China
Shanghai, , China
Shenzhen, , 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
Irapuato, , Mexico
Mazatlan, , Mexico
Legnica, , Poland
Skierniewice, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Zarow, , Poland
Smederevo, , Serbia
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
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
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported