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NCT Number: NCT07755904

BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy

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.

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Key information

Conditions

Cardiomyopathy, Hypertrophic Obstructive Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BHB-1893

Drug

Tablets for oral use

metoprolol

Drug

Capsules for oral use

Primary outcomes

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

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Change from Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)

    Time frame: Baseline, Week 24

  2. Number of Participants with >=1 Class Improvement in New York Heart Association (NYHA) Class

    Time frame: Baseline to Week 24

  3. Change from Baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)

    Time frame: Baseline, Week 24

  4. Change from Baseline in Left Atrial Volume Index

    Time frame: Baseline, Week 24

  5. Percent Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Concentration

    Time frame: Baseline, Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

(415) 707-6312

Sponsors and collaborators

Lead sponsor

Braveheart Bio, Inc.

Industry

Registry information

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

Acronym: LIONHEART-HCM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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