NCT07755904 · Braveheart Bio, Inc.
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
(LIONHEART-HCM)
What this study is about
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.
View original scientific description
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
DRUG
BHB-1893
Tablets for oral use
DRUG
Metoprolol
Capsules for oral use
Primary outcome measures
Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
Time frame: Baseline, Week 24
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Manhasset, New York
- Rock Hill, South Carolina
- Plano, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations