BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy

Phase 3Not Yet RecruitingNCT07755904

Braveheart Bio, Inc.210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

210

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Interventions

BHB-1893DRUG

Tablets for oral use

MetoprololDRUG

Capsules for oral use

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Baseline, Week 24

Secondary Outcomes

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

Time frame: Baseline, Week 24

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

Time frame: Baseline to Week 24

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

Time frame: Baseline, Week 24

Change from Baseline in Left Atrial Volume Index

Time frame: Baseline, Week 24

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

Time frame: Baseline, Week 24

Central Contacts

Study Director

CONTACT

(415) 707-6312 info@braveheart.bio

Data from ClinicalTrials.gov

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