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BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy

RecruitingPhase 3

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

Who can join

Ages 18 to 85 · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Braveheart Bio, Inc. · Participants: 210 · Started: Sep 2, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07755904

Locations in the U.S.

New YorkLIONHEART-HCM Site 0107, Manhasset
South CarolinaLIONHEART-HCM Site 0126, Rock Hill
TexasLIONHEART-HCM Site 0121, Plano

Conditions

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.