BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy

NCT07755904 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: BHB-1893-3012026-526007-30-00
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

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

Keywords

oHCM; BHB-1893

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)

  Baseline, Week 24

Secondary Outcomes (5)

• 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

Study Arms (2)

BHB-1893

EXPERIMENTAL

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

Drug: BHB-1893

Metoprolol

ACTIVE COMPARATOR

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

Drug: Metoprolol

Interventions

Metoprolol DRUG

Capsules for oral use

Metoprolol

BHB-1893 DRUG

Tablets for oral use

BHB-1893

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braveheart Bio, Inc.: lead

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Central Study Contacts

Study Director

CONTACT

(415) 707-6312; info@braveheart.bio

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share