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NCT07755904PHASE3Recruiting

BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy

Braveheart Bio, Inc.

Start Date

9/2/2026

Completion Date

11/1/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to 85 years

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.

Interventions

DRUG

BHB-1893

DRUG

Metoprolol

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Conditions

Cardiomyopathy, Hypertrophic Obstructive

Locations

LIONHEART-HCM Site 0107

Manhasset, New York 11030

United States

LIONHEART-HCM Site 0126

Rock Hill, South Carolina 29732

United States

LIONHEART-HCM Site 0121

Plano, Texas 75024

United States