BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
Cardiomyopathy, Hypertrophic Obstructive
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 18 years - 85 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 210 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
BHB-1893
Participants will receive BHB-1893 twice daily and matching placebo for metoprolol once daily.
Drug: BHB-1893
Metoprolol
Participants will receive metoprolol once daily and matching placebo for BHB-1893 twice daily.
Drug: Metoprolol
BHB-1893 DRUG
Tablets for oral use
Metoprolol DRUG
Capsules for oral use
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
Time frame: Baseline, Week 24
Not reported in this registry record.
Secondary measures
Change from Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)
Time frame: Baseline, Week 24
Not reported in this registry record.
Number of Participants with >=1 Class Improvement in New York Heart Association (NYHA) Class
Time frame: Baseline to Week 24
Not reported in this registry record.
Change from Baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Time frame: Baseline, Week 24
Not reported in this registry record.
Change from Baseline in Left Atrial Volume Index
Time frame: Baseline, Week 24
Not reported in this registry record.
Percent Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Concentration
Time frame: Baseline, Week 24
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (4)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
4 locations
LIONHEART-HCM Site 0120Burlington, Massachusetts, United StatesRecruiting
LIONHEART-HCM Site 0107Manhasset, New York, United StatesRecruiting
LIONHEART-HCM Site 0126Rock Hill, South Carolina, United StatesRecruiting
LIONHEART-HCM Site 0121Plano, Texas, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Braveheart Bio, Inc.
- Study start
- Sep 2, 2026 Actual
- Primary completion
- 2028-10 Estimated
- Study completion
- 2028-11 Estimated
- First posted
- Aug 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026
