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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

StatusRecruiting
PhasePhase 3
Started2025-05-20
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
minor
Study Status, Contacts/Locations v32
Trial sites reduced: 588 → 585 locations
2026-08-20
minor
Study Status, Contacts/Locations v31
Study sites588→589
2026-08-05
minor
Study Status, Contacts/Locations v30
Trial sites reduced: 632 → 588 locations
2026-07-08
minor
Study Status, Contacts/Locations v29
Trial sites reduced: 635 → 632 locations
2026-06-23
minor
Study Status, Contacts/Locations v28
Study sites635 entries, revised
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
2026-06-09
minor
Study Status, Contacts/Locations v27
Study sites635 entries, revised
ZugloiKardio EgeszsegugyiInnova SzolgalatKft.
2026-05-31
minor
Study Status, Contacts/Locations v26
Trial sites reduced: 639 → 635 locations
2026-05-12
minor
Study Status, Contacts/Locations v25
Study sites638→639
2026-04-28
minor
Study Status, Contacts/Locations v24
Study sites638 entries, revised
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
2026-04-14
minor
Study Status, Contacts/Locations v23
Study sites638 entries, revised
Chang-HuaChanghua Christian Hospital
2026-04-01
minor
Study Status, Contacts/Locations v22
Trial sites reduced: 641 → 638 locations
2026-03-17
minor
Study Status, Study Description, Outcome Measures, Contacts/Locations v21
Study sites644→641
Secondary endpoints13 entries, revised
Key secondary endpoint: Time to first event of cardiovascular death or hospitalisation for heart failureHHF Key secondary endpoint: Occurrences of hospitalisation for heart failureHHF (first and recurrent) Time to first hospitalisation for heart failureHHF
2026-03-04
minor
Study Status, Contacts/Locations v20
Study sites637→644
2026-02-17
minor
Study Status, Contacts/Locations, IPDSharing, References v19
Study sites636→637
2026-02-04
minor
Study Status, Contacts/Locations v18
Study sites634→636
2026-01-20
minor
Study Status, Contacts/Locations v17
Study sites634 entries, revised
Hospital Universitario Virgen de la Victoria Hospital Clinico Universitario Dede Valencia Hospital Universitari i Politècnic La Fe Hospital Virgen de las Montañas, Villamartin
2026-01-08
minor
Study Status, Contacts/Locations v16
Study sites622→634
2025-12-19
minor
Study Status, Contacts/Locations v15
Study sites621→622
2025-12-11
minor
Study Status, Contacts/Locations v14
Study sites620→621
2025-11-25
minor
Study Status, Contacts/Locations v13
Study sites613→620
2025-11-11
minor
Study Status, Contacts/Locations v12
Study sitesdetails revised at 9 of 613 sites
2025-10-29
minor
Study Status, Contacts/Locations v11
Study sites612→613
2025-10-15
minor
Study Status, Study Description, Contacts/Locations v10
Study sites607→612
2025-10-06
minor
Study Status, Contacts/Locations v9
Start date2025-06-17→2025-05-20
Study sites607 entries, revised
Sanatorio Parque S.A. AZO.L.Vrouw Sint-Blasiusvan Troost Ziekenhuis Oost-Limburg CHU - Campus Sint-Jan La Louvière - UNIV CHUde Tivoli Liège - HOSP CHR de la Citadelle UniversidadeNucleo Federalde Pesquisa Clinica do Rio Grande do Sul (NPCRS) Sygehus SonderJylland/Sønderjylland SonderborgÅbenrå Hospital Universitario La Paz
2025-09-19
minor
Study Status, Arms and Interventions, Contacts/Locations v8
InterventionsEmpagliflozin (Drug), Placebo matching vicadrostat (Drug), Vicadrostat (Drug)→Placebo (Drug), empagliflozin (Drug), vicadrostat (Drug)
Study sitesdetails revised at 1 of 607 sites
2025-09-17
minor
Study Status, Contacts/Locations v7
Study sites602→607
2025-09-02
minor
Study Status, Contacts/Locations v6
Study sites598→602
2025-08-21
minor
Study Status, Contacts/Locations v5
Start date2025-05-20→2025-06-17
Study sites575→598
2025-07-25
minor
Study Status, Contacts/Locations v4
Study sites562→575
2025-06-10
minor
Study Status, Contacts/Locations v3
Study sites518→562
2025-06-03
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Completion date2029-02-12→2029-02-22
Start dateestimated 2025-06-07→confirmed 2025-05-20
Study sites348→518
2025-04-30
minor
Study Status, Contacts/Locations v1
Study sites283→348
2025-04-17
minor
Original filing
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Trial Details
NCT Number NCT06935370
Lead Sponsor Boehringer Ingelheim
Conditions Heart Failure
Enrollment 4,200 participants
Start Date 2025-05-20
Primary Completion 2029-02-04 (estimated)
Study Completion 2029-02-22 (estimated)
Updated on ClinicalTrials.gov 2026-10-01