Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT07755904
RecruitingNCT07755904ClinicalTrials.gov record

BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy

Cardiomyopathy, Hypertrophic Obstructive

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Phase 3
Age range
18 years - 85 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
210 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Quadruple masked
BHB-1893

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

Drug: BHB-1893

Metoprolol

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

Drug: Metoprolol

BHB-1893 DRUG

Tablets for oral use

Metoprolol DRUG

Capsules for oral use

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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

Time frame: Baseline, Week 24

Not reported in this registry record.

Secondary measures

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

Time frame: Baseline, Week 24

Not reported in this registry record.

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

Time frame: Baseline to Week 24

Not reported in this registry record.

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

Time frame: Baseline, Week 24

Not reported in this registry record.

Change from Baseline in Left Atrial Volume Index

Time frame: Baseline, Week 24

Not reported in this registry record.

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

Time frame: Baseline, Week 24

Not reported in this registry record.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (4)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

4 locations

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

Study team and timeline

Lead sponsor
Braveheart Bio, Inc.
Study start
Sep 2, 2026 Actual
Primary completion
2028-10 Estimated
Study completion
2028-11 Estimated
First posted
Aug 10, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026