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%

Plain English Summary

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure is a Phase 3 clinical trial sponsored by Boehringer Ingelheim studying Heart Failure. Tests if combining Vicadrostat and Empagliflozin helps people with heart failure. For adults with heart failure symptoms and LVEF ≥40%. Participation involves taking daily tablets and regular doctor visits. Alternatives include standard heart failure treatments. The trial aims to enroll 6000 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 or older with heart failure symptoms and LVEF ≥40% can join. Women of childbearing potential must use effective birth control. People with structural heart abnormalities and elevated NT-proBNP can join. Exclusion criteria include recent major surgery, myocardial infarction, or specific medications. This trial is studying Heart Failure, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the time to first event of cardiovascular death, hospitalization for heart failure, or urgent heart failure visit. The specific primary outcome measures are: Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit (up to 42 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a treatment gap for heart failure patients with preserved ejection fraction. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Heart Failure, where improved treatment options are needed.

Investor Insight

The market for heart failure treatments is large, with this trial potentially offering a new option. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 6000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have heart failure symptoms and LVEF ≥40%. Participation involves taking daily tablets and regular doctor visits. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 6,000 participants

Interventions

• DRUG: vicadrostat — vicadrostat
• DRUG: empagliflozin — empagliflozin
• DRUG: placebo — placebo matching vicadrostat

Primary Outcomes

• Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit (up to 42 months)

Secondary Outcomes

• Key secondary endpoint: Time to first event of CV death or HHF (up to 42 months)
• Key secondary endpoint: Occurrence of HHFs (first and recurrent) (up to 42 months)
• Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 32 (at baseline, at week 32)
• Key secondary endpoint: Time to CV death (up to 42 months)
• Key secondary endpoint: Time to all-cause mortality (up to 42 months)

Full Eligibility Criteria

Inclusion criteria:

1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information
4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2
5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:

   1. in participants with body mass index (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
   2. in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
   3. in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
7. At least one of the following:

   * Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
   * Documented hospitalisation for HF within 6 months prior to Visit 1
   * Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1

     * in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
     * for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
   * Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1
8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply.

Exclusion criteria:

1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study
2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator
3. Receiving the following treatments:

   * a direct renin inhibitor (e.g. aliskiren) at Visit 2
   * more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2
   * In case of acute decompensated HF:

     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)
     * i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective sur

Trial Locations

• Diagnostic and Medical Clinic, Mobile, Alabama, United States
• Mobile Heart Specialists, PC, Mobile, Alabama, United States
• Velocity Clinical Research-Chula Vista, Chula Vista, California, United States
• University of California Irvine, Orange, California, United States
• North America Research Institute, San Dimas, California, United States
• Amicis Research Center - Valencia, Santa Clarita, California, United States
• Orange County Research Center, Tustin, California, United States
• Bridgeport Hospital, Bridgeport, Connecticut, United States
• Excel Medical Clinical Trials, Boca Raton, Florida, United States
• Bay Area Cardiology, Brandon, Florida, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Heart failure
• Cardiovascular diseases
• Cardiology
• Heart disease
• Cardiovascular health
• Heart conditions
• Heart disease treatments
• Heart failure management
• Heart failure therapies
• Heart failure research

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