Cardiomyopathy, Hypertrophic Obstructive
Conditions
Keywords
oHCM, BHB-1893
Brief 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.
Interventions
DRUGBHB-1893
Tablets for oral use
DRUGMetoprolol
Capsules for oral use
Sponsors
Braveheart Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET) | Baseline, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G) | Baseline, Week 24 |
| Number of Participants with >=1 Class Improvement in New York Heart Association (NYHA) Class | Baseline to Week 24 |
| Change from Baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) | Baseline, Week 24 |
| Change from Baseline in Left Atrial Volume Index | Baseline, Week 24 |
| Percent Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Concentration | Baseline, Week 24 |
Contacts
CONTACTStudy Director
Outcome results
None listed