Recruiting
Phase 3

BHB-1893 vs. Metoprolol

Sponsor:

Braveheart Bio, Inc.

Code:

NCT07755904

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BHB-1893

Metoprolol

Study Details

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.

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Study ID

NCT07755904

Start date

Sep 2, 2026

Status verified date

Sep, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BHB-1893

Participants will receive BHB-1893 twice daily and matching placebo for metoprolol once daily.

active comparator: Metoprolol

Participants will receive metoprolol once daily and matching placebo for BHB-1893 twice daily.

Interventions

BHB-1893

Tablets for oral use

Metoprolol

Capsules for oral use

Primary outcome measure

  • Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET) [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Study Director

(415) 707-6312info@braveheart.bio

Locations

LIONHEART-HCM Site 0107

Recruiting

Manhasset, New York, United States, 11030

LIONHEART-HCM Site 0126

Recruiting

Rock Hill, South Carolina, United States, 29732

LIONHEART-HCM Site 0121

Recruiting

Plano, Texas, United States, 75024

More Information

Sponsor

Braveheart Bio, Inc.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • oHCM
  • BHB-1893

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Braveheart Bio, Inc. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.