BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy (LIONHEART-HCM)

August 5, 2026 updated by: Braveheart Bio, Inc.

A Phase 3, Multi-region, Multi-center, Randomized, Double-blind, Active-Comparator-Controlled Trial to Evaluate the Efficacy and Safety of BHB-1893 Compared to Metoprolol in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

The main purpose of this trial is to find out whether BHB-1893 works better than metoprolol in adults with symptoms of obstructive hypertrophic cardiomyopathy (oHCM). The trial includes adults who are currently being treated for oHCM or who have not yet been treated.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Diagnosed with oHCM per the protocol specified criteria
  • NYHA Class II or III at screening visits
  • KCCQ-CSS that meets the protocol specified criteria at screening visits
  • Adequate acoustic windows for echocardiography

Key Exclusion Criteria:

  • Medical indication for either β-blocker or calcium-channel blocker therapy, other than oHCM, prohibiting drug discontinuation
  • History of intolerance or medical contraindication to β-blocker therapy
  • Resting systolic blood pressure (SBP) of >160 millimeters of mercury (mmHg) at screening visits
  • Resting heart rate of >100 beats per minute (bpm) at screening visits

  • Significant valvular heart disease, defined as:

    • Moderate to severe valvular aortic stenosis or fixed subaortic obstruction;
    • Mitral regurgitation not due to systolic anterior motion of the mitral valve (per Investigator's judgment)

Other protocol-defined criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BHB-1893
Participants will receive BHB-1893 twice daily and matching placebo for metoprolol once daily.
Drug: BHB-1893
Tablets for oral use
Active Comparator: Metoprolol
Participants will receive metoprolol once daily and matching placebo for BHB-1893 twice daily.
Drug: Metoprolol
Capsules for oral use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
Time Frame: Baseline, Week 24
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)
Time Frame: Baseline, Week 24
Baseline, Week 24
Number of Participants with >=1 Class Improvement in New York Heart Association (NYHA) Class
Time Frame: Baseline to Week 24
Baseline to Week 24
Change from Baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from Baseline in Left Atrial Volume Index
Time Frame: Baseline, Week 24
Baseline, Week 24
Percent Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Concentration
Time Frame: Baseline, Week 24
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Braveheart Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHB-1893-301
  • 2026-526007-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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