EASi-HF Reduced – A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) < 40%

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519525-38-00

Acronym

1378-0018

Enrollment

1539

Registered

2025-07-18

Start date

2025-08-22

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Brief summary

The composite primary endpoint addressing the primary objective is as follows: Time to first event of • Cardiovascular (CV) death; or • Hospitalisation for heart failure (HHF); or • Urgent heart failure (HF) visit

Detailed description

Time to first event of cardiovascular death or hospitalisation for heart failure, Occurrences of hospitalisation for heart failure (first and recurrent), Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 32

Interventions

DRUGEMPAGLIFLOZIN

DRUGBI 690517

DRUGPlacebo matching vicadrostat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The composite primary endpoint addressing the primary objective is as follows: Time to first event of • Cardiovascular (CV) death; or • Hospitalisation for heart failure (HHF); or • Urgent heart failure (HF) visit	—

Secondary

Measure	Time frame
Time to first event of cardiovascular death or hospitalisation for heart failure, Occurrences of hospitalisation for heart failure (first and recurrent), Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 32	—

Countries

Belgium, Bulgaria, Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026