Health TrialsbyHealthPanel

BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy

ConditionCardiomyopathy, Hypertrophic Obstructive
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBraveheart Bio, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BHB-1893

    Drug

    Tablets for oral use

  • Metoprolol

    Drug

    Capsules for oral use

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: BHB-1893Experimental treatment 1 intervention
Group B: MetoprololActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Braveheart Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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