EASi-HF Preserved – 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 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

CTIS2023-509706-30-00

Acronym

1378-0020

Enrollment

2461

Registered

2024-09-10

Start date

2024-10-18

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 (HF)

Brief summary

The composite primary endpoint is the time to first event of CV death, HHF or urgent HF visit. CV death includes death of undetermined cause.

Detailed description

Time to first event of CV death or HHF., Occurrence of HHFs (first and recurrent)., Absolute change from baseline in KCCQ-TSS at Week 32.

Interventions

DRUGPlacebo matching BI 690517

DRUGEMPAGLIFLOZIN

DRUGBI 690517

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The composite primary endpoint is the time to first event of CV death, HHF or urgent HF visit. CV death includes death of undetermined cause.	—

Secondary

Measure	Time frame
Time to first event of CV death or HHF., Occurrence of HHFs (first and recurrent)., Absolute change from baseline in KCCQ-TSS at Week 32.	—

Countries

Belgium, Bulgaria, Czechia, Germany, Hungary, Italy, Netherlands, Poland, Romania, Slovenia, Spain

Outcome results

None listed

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