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RECRUITING Phase 3

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

NCT06424288 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG vicadrostat
  • DRUG empagliflozin

Study Locations (20)

Florida

  • Excel Medical Clinical Trials — Boca Raton
  • Bay Area Cardiology — Brandon
  • Clearwater Cardiovascular and Interventional Consultants — Clearwater
  • Cardiology Associates Research Co. — Daytona Beach
  • Malcom Randall VA Medical Center — Gainesville
  • Velocity Clinical Research-Hallandale Beach-67888 — Hallandale
  • University of Florida Health Jacksonville — Jacksonville
  • East Coast Institute for Research, LLC - Jacksonville — Jacksonville
  • East Coast Institute for Research, LLC - Jacksonville — Jacksonville
  • First Coast Cardiovascular Institute — Jacksonville
  • Clearwater Cardiovascular Consultants-Largo-69917 — Largo
  • University of Miami — Miami

California

  • Velocity Clinical Research-Chula Vista — Chula Vista
  • University of California Irvine — Orange
  • North America Research Institute — San Dimas
  • Amicis Research Center - Valencia — Santa Clarita
  • Orange County Research Center — Tustin

Alabama

  • Diagnostic and Medical Clinic — Mobile
  • Mobile Heart Specialists, PC — Mobile

Connecticut

  • Bridgeport Hospital — Bridgeport

Trial Details

FieldValue
Enrollment Target 6,000 participants
Start Date 2024-06-17
Est. Completion 2028-05-22
Phase Phase 3

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06424288

The ClinicalTrials.gov registry entry for NCT06424288 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 3 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06424288 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06424288 about?

NCT06424288 is a clinical study titled "A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure". 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 empag...

What is the current status of trial NCT06424288?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 6,000 participants. The study started on 2024-06-17. Estimated completion is 2028-05-22.

What conditions does trial NCT06424288 study?

This clinical trial studies the following conditions: Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06424288?

The interventions under investigation include: placebo (DRUG), vicadrostat (DRUG), empagliflozin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06424288?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06424288 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial