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vicadrostat / Heart Failure / empagliflozin · Phase 3 Trial
ClinicalTrials.gov · August 6, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial registration comparing vicadrostat combined with empagliflozin against placebo combined with empagliflozin in adults with chronic heart failure and reduced ejection fraction (LVEF <40%). The study is actively recruiting and no efficacy or safety results have been posted to the registry; the primary outcome will be time to first event of cardiovascular death, hospitalization for heart failure, or urgent heart failure visit over up to 43 months of follow-up.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Heart Failure; age from 18 Years. Intervention: vicadrostat/empagliflozin treatment group. Compared with: Placebo to vicadrostat/empagliflozin treatment group — Placebo Comparator. n = 4,200. 588 sites across 29 countries.
This is a Phase 3 randomized controlled trial registration comparing vicadrostat combined with empagliflozin against placebo combined with empagliflozin in adults with chronic heart failure and reduced ejection fraction (LVEF <40%). The study is actively recruiting and no efficacy or safety results have been posted to the registry; the primary outcome will be time to first event of cardiovascular death, hospitalization for heart failure, or urgent heart failure visit over up to 43 months of follow-up.
Results are not yet reported in this registry record; no efficacy or safety data are available for clinical decision-making.
The source did not state who this applies to in practice.
This is a Phase 3 trial registration with no results posted; the study is actively recruiting and outcome data are not yet available, making it an ongoing investigation rather than evidence of efficacy.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06935370). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 4200 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DRUG: vicadrostat; DRUG: empagliflozin; DRUG: Placebo. Primary outcome measures: Time to first event of Cardiovascular (CV) death, or Hospitalisation for heart failure (HHF), or Urgent heart failure (HF) visit , up to 43 months. Brief summary: 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.
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