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A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

StatusRecruiting
PhasePhase 3
Started2024-06-17
View on ClinicalTrials.gov ↗

Amendment history

The 48 most recent of 53 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-10-02
Trial sites expanded: 653 → 664 locations
2026-09-23
Enrollment increased: 6000 → 6712 participants
2026-08-20
Study Status, Contacts/Locations v52
Study sites652 entries, revised
Clinica Coronel SuárezSuarez Instituto de Investigaciones ClínicasClinicas de Quilmes Centro de Investigaciones ClínicasClinicas del Litoral Guizhou Provincial People's Hospital Jining No.1 peoplePeople's hospitalHospital
2026-08-05
Study Status, Contacts/Locations v51
Study sites652 entries, revised
TexasHospital HealthMaternidade Researche andPronto EducationSocorro InstituteSanta Lucia Lausmed Kft. Outpatient Unit of Internal Medicine
2026-07-08
Study Status, Contacts/Locations v50
Study sites652 entries, revised
CEPIC - Centro Paulista de Investigacao Clinica e Servicos
Show 45 earlier versions
2026-06-12
Study Status, Contacts/Locations v49
Study sites651→652
2026-05-31
Study Status, Contacts/Locations v48
Study sites653→651
2026-05-12
Study Status, Contacts/Locations v47
Study sites653 entries, revised
HospitalCentro MaeGaucho Integrado de DeusOncologia, Hematologia, Ensino e Pesquisa Sociedade Simples Royal Devon and Exeter Hospital, Wonford
2026-04-28
Study Status, Contacts/Locations v46
Study sites653 entries, revised
University of Utah HospitalHealth Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
2026-04-14
Study Status, Contacts/Locations v45
Study sites652→653
2026-04-01
Study Status, Contacts/Locations v44
Study sites652 entries, revised
Hospital Universitari Vall D d'Hebron Royal Devon and Exeter Hospital, Wonford York and Scarborough Teaching Hospitals NHS Foundation Trust York Hospital
2026-03-17
Study Status, Contacts/Locations v43
Study sites646→652
2026-03-04
Study Status, Contacts/Locations v42
Study sites637→646
2026-02-17
Study Status, Contacts/Locations v41
Study sites632→637
2026-02-04
Study Status, Contacts/Locations, IPDSharing, References v40
Study sites632 entries, revised
West China Hospital of, Sichuan University
2026-01-20
Study Status, Contacts/Locations v39
Study sites630→632
2026-01-07
Study Status, Contacts/Locations v38
Study sites608→630
2025-12-19
Study Status, Contacts/Locations v37
Study sites588→608
2025-12-11
Study Status, Contacts/Locations v36
Study sites583→588
2025-11-25
Study Status, Contacts/Locations v35
Study sites578→583
2025-11-11
Study Status, Contacts/Locations v34
Study sites576→578
2025-10-29
Study Status, Contacts/Locations v33
Study sites576 entries, revised
ClinicaSanatorio PrivadaPrivado Colombo-Duarte FundacionQuiros De Clinica Colombo SA UMHAT "Sv. Georgi", EAD ObudaObudai HealthEgeszegugyi CenterCentrum Kft. Hospital ClínicoClinico deUniversitario De Valencia Chang Gung Memorial Hospital, Linkou
2025-10-15
Study Status, Study Description, Arms and Interventions, Contacts/Locations v32
InterventionsPlacebo (Drug), empagliflozin (Drug), vicadrostat (Drug)→empagliflozin (Drug), placebo (Drug), vicadrostat (Drug)
Study sites576 entries, revised
AZ Sint-Lucas - Campus Sint Lucas Kortrijk - HOSP AZ Groeninge Kennedylaan National MultiprofileMultidisciplinary Transport Hospital, SofiaTsar Boris III Alexandrovska University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD MHATUMHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, SofiaEAD
2025-10-06
Study Status, Contacts/Locations v31
Study sites576 entries, revised
Ziekenhuis Oost-Limburg - Campus Sint-Jan Pusan National Univ.University HospHospital Hospital Universitario La Paz Chang Gung Memorial Hospital( Linkou)
2025-09-19
Study Status, Arms and Interventions v30
InterventionsEmpagliflozin (Drug), Placebo (Drug), vicadrostat (Drug)→Placebo (Drug), empagliflozin (Drug), vicadrostat (Drug)
2025-09-17
Study Status, Contacts/Locations v29
Study sites575→576
2025-09-02
Study Status, Contacts/Locations v28
Study sitesdetails revised at 8 of 575 sites
2025-08-21
Study Status, Contacts/Locations v27
Study sites592→575
2025-07-25
Study Status, Contacts/Locations v26
Study sites592 entries, revised
FarVivantes EasternNetzwerk Memorialfür HospitalGesundheit GmbH
2025-07-08
Study Status, Contacts/Locations v25
Study sites592 entries, revised
Motol University Hospital Motol
2025-06-26
Study Status, Contacts/Locations v24
Study sites590→592
2025-06-10
Study Status, Contacts/Locations v23
Primary completion date2027-11-15→2028-05-22
Completion date2027-11-15→2028-05-22
Study sites589→590
2025-05-27
Study Status, Contacts/Locations v22
Study sitesdetails revised at 79 of 589 sites
2025-04-30
Study Status, Contacts/Locations v21
Study sites588→589
2025-04-22
Study Status, Contacts/Locations v20
Study sites448→588
2025-04-01
Study Status, Contacts/Locations v19
Study sites441→448
2025-03-21
Study Status, Contacts/Locations v18
Study sites440→441
2025-03-05
Study Status, Contacts/Locations v17
Study sites491→440
2025-02-19
Study Status, Contacts/Locations v16
Study sites21→491
2025-02-07
Study Status, Eligibility, Contacts/Locations v15
Study sites18→21
Eligibility criteria-456 characters
[...] er (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI), or twoused simultaneously at Visit 2 In case of acute decompensated HF [...] treatment during the study Further exclusion criteria apply. Serum potassium >5.2 mmol/L measured by the central laboratory at Visit 1 (Note: one reassessment of serum potassium is allowed during screening) Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m² (Chronic Kidney Disease Epidemiology Collaboration (CK [...]
2025-01-22
Study Status, Outcome Measures v14
Secondary endpointsdetails revised at 1 of 13 entries
2025-01-20
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v13
Study sites17→18
InterventionsBI 690517 (Drug), Empagliflozin (Drug), Placebo (Drug)→Empagliflozin (Drug), Placebo (Drug), vicadrostat (Drug)
Eligibility criteria+1,191 characters
[...] e measured after study consent has been obtained and before randomisation at Visit 2 Presence of structural heart abnormality (confirmed [...] cipants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL ParticipantsUrine mustalbumin-to-creatinine beratio treated(UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1 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 (according to theand judgment o [...] [...]
Secondary endpoints9 to 13 entries
Key secondary endpoint: Time to first event of CV death, HHF or urgent heart failure visitHHF Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or onset of sustained reduction of ≥4050% estimatedeGFR glomerularfrom filtration rate (eGFR)baseline** or onset of sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m²m2 (composite renal endpoint) Absolute change from baseline in KCCQ-OSS at Week 32 Absolute change from baseline in KCCQ-OSS at Week 52 Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP ≥ [...]
Primary endpoints1 entry, revised
Time to first event of Cardiovascular (CV) death, or Hospitalisationhospitalisation for heart failure (HHF) or urgent heart failure (HF) visit
Study title+2 characters
A Study to Test Whether BI 690517Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
2024-12-16
Study Status, Contacts/Locations v12
Study sites15→17
2024-11-28
Study Status, Contacts/Locations v11
Start date2024-05-31→2024-06-17
Study sites112→15
2024-10-30
Study Status, Contacts/Locations v10
Study sites66→112
2024-10-15
Study Status, Contacts/Locations v9
Study sites55→66
2024-10-04
Study Status, Arms and Interventions, Contacts/Locations v8
Study sites52→55
2024-10-01
Study Status, Contacts/Locations v7
Study sites43→52
2024-09-03
Study Status, Contacts/Locations v6
Study sites40→43
2024-08-21
Study Status, Contacts/Locations v5
Study sites21→40
This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.
Trial Details
NCT Number NCT06424288
Lead Sponsor Boehringer Ingelheim
Conditions Heart Failure
Enrollment 6,712 participants
Start Date 2024-06-17
Primary Completion 2028-05-22 (estimated)
Study Completion 2028-05-22 (estimated)
Updated on ClinicalTrials.gov 2026-10-01