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
Braveheart Bio, Inc.
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
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugBHB-1893
Tablets for oral use
- DrugMetoprolol
Capsules for oral use
Locations (3)
- LIONHEART-HCM Site 0107Manhasset, New York
- LIONHEART-HCM Site 0126Rock Hill, South Carolina
- LIONHEART-HCM Site 0121Plano, Texas