BHB-1893 vs metoprolol for symptomatic obstructive hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 study compares the effects of BHB-1893 to metoprolol in adults with obstructive hypertrophic cardiomyopathy who have symptoms. Participants must have NYHA class II or III symptoms and meet specific criteria related to quality of life scores and heart function; echocardiography suitability is required. The trial will evaluate outcomes over time to see which treatment provides better symptom control and heart health. Sites are in Massachusetts, New York, and South Carolina under Braveheart Bio, Inc. as lead sponsor, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• LIONHEART-HCM Site 0120
  Burlington, Massachusetts, United States Recruiting
• LIONHEART-HCM Site 0107
  Manhasset, New York, United States Recruiting
• LIONHEART-HCM Site 0126
  Rock Hill, South Carolina, United States Recruiting
• LIONHEART-HCM Site 0121
  Plano, Texas, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@braveheart.bio
• Phone: (415) 707-6312

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Assessing health changes in patients with obstructive hypertrophic cardiomyopathy treated with mavacamten

  This study is testing how well the medication mavacamten helps adults with obstructive hypertrophic cardiomyopathy feel and do better in their everyday lives.

  Recruiting Bristol-Myers Squibb · Boston, Massachusetts · NCT06551129

• Assessing the safety of mavacamten in Korean patients with obstructive hypertrophic cardiomyopathy

  This study is testing how safe the medication mavacamten is for adults in Korea who have symptoms of obstructive hypertrophic cardiomyopathy.

  Recruiting Bristol-Myers Squibb · Seoul and 1 other locations · NCT06146660

• Effect of mavacamten on heart blood flow in obstructive hypertrophic cardiomyopathy

  This study is testing if the medication mavacamten can improve blood flow in the hearts of people with obstructive hypertrophic cardiomyopathy after a year of treatment.

  Recruiting University of Virginia · Charlottesville, Virginia · NCT06023186

• Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy

  This study is trying to learn more about how people with obstructive hypertrophic cardiomyopathy are treated and what their experiences are, especially for those using the medication mavacamten.

  Recruiting at 76 sites Bristol-Myers Squibb · Anchorage, Alaska and 100 other locations · NCT05489705

• Mavacamten outcomes and real-world patient and physician experiences for obstructive HCM in the US

  See how mavacamten works and what patients and doctors experience for adults with obstructive hypertrophic cardiomyopathy treated in US community practice.

  Recruiting Bristol-Myers Squibb · Bollington, Macclesfield · NCT07557498

• Mavacamten treatment for obstructive hypertrophic cardiomyopathy in Japan

  This project will try mavacamten in patients in Japan with obstructive hypertrophic cardiomyopathy to see if it works well and is safe during routine care.

  Recruiting Bristol-Myers Squibb · Tokyo · NCT07383025

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.