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
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