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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 comparing vicadrostat plus empagliflozin versus placebo plus empagliflozin in heart failure, currently recruiting. No results have been posted to this registry record; the study remains in active enrollment with a primary outcome of time to cardiovascular death, heart failure hospitalization, or urgent heart failure visit over up to 42 months.
Phase 3, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Heart Failure; age from 18 Years. Intervention: vicadrostat/empagliflozin. Compared with: placebo/empagliflozin — Placebo Comparator. n = 6,000. 652 sites across 30 countries.
This is a Phase 3 randomized controlled trial comparing vicadrostat plus empagliflozin versus placebo plus empagliflozin in heart failure, currently recruiting. No results have been posted to this registry record; the study remains in active enrollment with a primary outcome of time to cardiovascular death, heart failure hospitalization, or urgent heart failure visit over up to 42 months.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results are not yet available. Clinicians should monitor the registry or literature for completion of this trial before considering vicadrostat plus empagliflozin combinations for heart failure management.
This is a Phase 3 trial registration with no results posted; the study is actively recruiting and has not yet generated outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Results are not yet available. Clinicians should monitor the registry or literature for completion of this trial before considering vicadrostat plus empagliflozin combinations for heart failure management.
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 (NCT06424288). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 6000 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DRUG: vicadrostat; DRUG: empagliflozin; DRUG: placebo. Primary outcome measures: Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit , up to 42 months. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.