What is vicadrostat studying for heart failure?

Vicadrostat is being studied in combination with empagliflozin to see if it helps adults with symptomatic heart failure and a left ventricular ejection fraction of 40% or more. This trial aims to evaluate the safety and effectiveness of this combination to improve heart failure outcomes. The study is sponsored by Boehringer Ingelheim.

Who may be eligible for this heart failure clinical trial?

Adults aged 18 or older with symptoms of heart failure and a left ventricular ejection fraction of 40% or higher may be eligible. Both men and women can participate if they meet health criteria including stable heart failure treatment and no recent major heart surgeries. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can plan accordingly based on their own circumstances.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06424288

EASi-HF Preserved Trial to Evaluate Vicadrostat Plus Empagliflozin Compared With Placebo Plus Empagliflozin in Adults With Symptomatic Heart Failure and LVEF 40

Led by Boehringer Ingelheim · Updated on 2026-06-02

6000

Participants Needed

651

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin can help adults aged 18 and older who have heart failure symptoms and a left ventricular ejection fraction LVEF of 40 or more. This phase III trial aims to assess the safety and effectiveness of this treatment compared to placebo with empagliflozin. Heart failure participants are classified as New York Heart Association NYHA class II-IV, and the study is sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once daily, while the other group takes placebo plus empagliflozin tablets once daily. The study is double-blind, meaning neither participants nor researchers know who is receiving which treatment. Participants remain in the trial as long as they benefit from and tolerate the treatment. Regular doctor visits and phone contacts monitor participants throughout the study. During the study, participants undergo regular health checks, including blood tests and questionnaires about well-being. Researchers track key health outcomes such as time to cardiovascular death, hospitalizations for heart failure, and quality of life measures using the Kansas City Cardiomyopathy Questionnaire. The study continues until sufficient data is collected, which may take up to 42 months. Safety and treatment effects are closely monitored throughout the trial.

CONDITIONS

Brief Title

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

At least 18 years old and of legal consent age in the country
Signed informed consent before joining the trial
Male or female; women of childbearing potential must use highly effective birth control
Diagnosed with chronic heart failure for at least 3 months
New York Heart Association (NYHA) class II-IV at first visit
Left ventricular ejection fraction (LVEF) of 40% or higher
Structural heart abnormality confirmed by imaging
Elevated NT-proBNP levels according to BMI and heart rhythm
At least one of: stable diuretic therapy, recent heart failure hospitalization, elevated NT-proBNP, or elevated urine albumin-to-creatinine ratio
Treated according to best standard care excluding certain heart failure drugs

You will not qualify if you...

Treatment with mineralocorticoid receptor antagonist within 14 days before first visit or planned during trial
Treatment with amiloride or other potassium-sparing diuretics within 14 days before first visit or planned during trial
Use of direct renin inhibitors or multiple ACE inhibitors/ARBs at randomization
Recent acute decompensated heart failure requiring intravenous drugs or mechanical support within 24 hours before randomization
Recent increased intravenous diuretic dose within 6 hours before randomization
Use of systemic mineralocorticoid replacement therapy at randomization
Use or planned use of other aldosterone synthase inhibitors during trial
Major heart events or surgeries within 90 days before randomization
Recent coronary interventions or angiography with contrast within 7 days before randomization
Heart transplant recipient, awaiting transplant, or with left ventricular assist device
Known cardiomyopathies due to specific diseases or reversible causes within past year
Acute inflammatory heart disease within 90 days before first visit
Severe valvular heart disease or planned invasive valve treatment during study

Research Team

Boehringer Ingelheim

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