A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Launched by BOEHRINGER INGELHEIM · May 21, 2024
Trial Information
Current as of March 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for heart failure. Specifically, it aims to find out if a medication called BI 690517, when taken together with empagliflozin, can help improve symptoms in adults aged 18 and older who have heart failure. To join the study, participants should have a specific type of heart failure, known as reduced ejection fraction, with at least 40% heart function. They will be randomly assigned to one of two groups: one group will receive the combination of BI 690517 and empagliflozin, while the other group will receive a placebo (a dummy pill) along with empagliflozin.
Participants can stay in the study as long as the treatment is helping them and they can handle it. Throughout the trial, they will have regular check-ups with their doctors to monitor their health and any side effects. The study does not have a set end date; it will continue until enough information is gathered to determine if the treatment is effective. If you or someone you know has heart failure and meets the eligibility criteria, it might be an opportunity to contribute to important research while receiving care.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
- • 2. Signed and dated written informed consent in accordance with 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 International Conference on Harmonisation (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 participant information
- • 4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2
- • 5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
- 6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:
- • 1. in participants with body mass index (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
- • 2. in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
- • 3. in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
- 7. At least one of the following:
- • Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
- • Documented hospitalisation for HF within 6 months prior to Visit 1
- • Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1
- • in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
- • for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
- • Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1
- • 8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply.
- Exclusion criteria:
- • 1. Treatment with an mineralocorticoid receptor antagonist (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 MRA should not be interrupted with the intention of enrolment into the study
- • 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
- * 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 (Visit 2)
- • 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)
- • Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
- • Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- • 4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, 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, coronary artery bypass graft surgery/CABG)
- • 5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) 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 genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2
- • 8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
- • 9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study 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)
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Peterborough, Ontario, Canada
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Varna, , Bulgaria
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Elkhart, Indiana, United States
Gent, , Belgium
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Bad Friedrichshall, , Germany
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Kaohsiung, , Taiwan
Berlin, , Germany
Saint Louis, Missouri, United States
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Kortrijk, , Belgium
Armenia, , Colombia
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Poznan, , Poland
Szolnok, , Hungary
Hanoi, , Vietnam
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Santiago De Compostela, , Spain
Barnet, , United Kingdom
Jacksonville, Florida, United States
Wroclaw, , Poland
Gaziantep, , Turkey
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Hazel Crest, Illinois, United States
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Sofia, , Bulgaria
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Yueyang, , China
Xuancheng, , China
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Yambol, , Bulgaria
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Nanjing, , China
Chengdu, , China
Vishakhapatnam, , India
Ciudad Autonoma Buenos Aires, , Argentina
Rio De Janeiro, , Brazil
Wonju Si, Gangwon State, , Korea, Republic Of
Riyadh, , Saudi Arabia
Staszow, , Poland
Chenzhou, , China
Okinawa, Urasoe, , Japan
Merrillville, Indiana, United States
Ocala, Florida, United States
Port Charlotte, Florida, United States
Marion, Ohio, United States
Jackson, Tennessee, United States
Mobile, Alabama, United States
Libertyville, Illinois, United States
Park Ridge, Illinois, United States
Wichita, Kansas, United States
Dearborn, Michigan, United States
Lincoln, Nebraska, United States
Amarillo, Texas, United States
Valencia, California, United States
Lublin, , Poland
Wesley Chapel, Florida, United States
Jefferson City, Tennessee, United States
Mito Shi, , Japan
Edmonton, , Canada
Kobe Shi, , Japan
Ankara, , Turkey
Lansing, Michigan, United States
Hamada Shi, , Japan
Madison, Wisconsin, United States
Pleven, , Bulgaria
Pleven, , Bulgaria
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Stoney Creek, Ontario, Canada
St. Jean Sur Richelieu, , Canada
Brandys Nad Labem, , Czechia
Prague 10, , Czechia
Smirice, , Czechia
Berlin, , Germany
Budapest, , Hungary
Azumino Shi, , Japan
Higashiibaraki Gun, , Japan
Kamakura Shi, , Japan
Kanagawa, Yokohama, , Japan
Okayama Shi, , Japan
Saitama Shi, , Japan
Gdynia, , Poland
Kraków, , Poland
Iasi, , Romania
Jacksonville, Florida, United States
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Bossier City, Louisiana, United States
Shreveport, Louisiana, United States
New York, New York, United States
Exeter, , United Kingdom
Brno, , Czechia
Chula Vista, California, United States
Somerset, New Jersey, United States
Butler, Pennsylvania, United States
Pitesti, , Romania
Elazıg, , Turkey
Osaka, Osaka, , Japan
Chicago, Illinois, United States
Foggia, , Italy
Ciudad Autonoma Buenos Aires, , Argentina
Guiyang, , China
Alexandria, Louisiana, United States
Buenos Aire, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Bs As, , Argentina
Ciudad Autónoma De Bs As, , Argentina
Coronel Suarez, , Argentina
Córdoba, , Argentina
Frankston, Victoria, Australia
Gilly, , Belgium
Brasilia, , Brazil
Campinas, , Brazil
Curitiba, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Santo Andre, , Brazil
Santo Andre, , Brazil
Sao Jose Rio Preto, , Brazil
São Paulo, , Brazil
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
London, Ontario, Canada
St Catharines, Ontario, Canada
Trois Rivières, Quebec, Canada
Kitchener, , Canada
Montreal, , Canada
Montreal, , Canada
Montreal, , Canada
Oakville, , Canada
Sudbury, , Canada
Santiago, , Chile
Temuco, , Chile
Changchun, , China
Changde City, , China
Daqing City, , China
Deyang, , China
Guangzhou, , China
Guangzhou, , China
Guangzhou, , China
Hangzhou, , China
Harbin, , China
Huainan, , China
Jining, , China
Nanchang City, , China
Nanchang, , China
Nanyang, , China
Panjin, , China
Shanghai, , China
Shenzhen, , China
Wuhan, , China
Xi An, , China
Xuzhou, , China
Yinchuan, , China
Yuncheng, , China
Zhangjiakoou, , China
Barranquilla, , Colombia
Cartagena, , Colombia
Zipaquirá, , Colombia
Brandýs Nad Labem, , Czechia
Chrudim, , Czechia
Havlickuv Brod, , Czechia
Praha 1, , Czechia
Praha 4 Krc, , Czechia
Praha 4, , Czechia
Zlin, , Czechia
Kamp Lintfort, , Germany
Neuwied, , Germany
Stuhr, , Germany
Wallerfing, , Germany
Gyula, , Hungary
Pecs, , Hungary
Szeged, , Hungary
Bengaluru, , India
Bikaner, , India
Chennai, , India
Chennai, , India
Gurgaon, , India
Hokkaido, Tomakomai, , Japan
Iwakuni Shi, , Japan
Kanonji Shi, , Japan
Kishiwada Shi, , Japan
Kitaazumi Gun, , Japan
Matsuyama Shi, , Japan
Miura Gun, , Japan
Nakano Shi, , Japan
Osaka, Osaka, , Japan
Osaka, Osaka, , Japan
Saitama Shi, , Japan
Tomakomai Shi, , Japan
Aguascalientes, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Irapuato, , Mexico
Mazatlan, , Mexico
S Hertogenbosch, , Netherlands
Bialystok, , Poland
Katowice, , Poland
Legnica, , Poland
Ruda Slaska, , Poland
Skierniewice, , Poland
Warsaw, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Zamosc, , Poland
Zarow, , Poland
Balotesti, , Romania
Brasov, , Romania
Cluj Napoca, , Romania
Targu Mures, , Romania
Timisoara, , Romania
Smederevo, , Serbia
Golnik, , Slovenia
Jesenice, , Slovenia
Ljubljana, , Slovenia
Trbovlje, , Slovenia
Bloemfontein, , South Africa
Centurion, , South Africa
Sanlúcar De Barrameda, , Spain
Villamartin, Cardiz, , Spain
Adana, , Turkey
Eskisehir, , Turkey
Malatya, , Turkey
Pendik/ Istanbul, , Turkey
Trabzon, , Turkey
Ho Chi Minh, , Vietnam
Largo, Florida, United States
Libertyville, Illinois, United States
Lincoln, Nebraska, United States
London, Ontario, Canada
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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