Search > Hypertrophic Cardiomyopathy
210 Participants NeededMy employer runs this trial

BHB-1893 vs Metoprolol for Hypertrophic Cardiomyopathy

(LIONHEART-HCM Trial)

Recruiting at 2 trial locations
SD
Overseen ByStudy Director
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Braveheart Bio, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with obstructive hypertrophic cardiomyopathy who have moderate symptoms (NYHA Class II or III), can undergo heart ultrasound tests, and meet certain health questionnaire scores. Both those already on treatment and those not yet treated may join.

Inclusion Criteria

KCCQ-CSS that meets the protocol specified criteria at screening visits
My heart failure is moderate and limits my activity somewhat.
I have been diagnosed with obstructive hypertrophic cardiomyopathy.
See 1 more

Exclusion Criteria

Resting heart rate of >100 beats per minute (bpm) at screening visits
Resting systolic blood pressure (SBP) of >160 millimeters of mercury (mmHg) at screening visits
I have moderate to severe aortic valve disease or a fixed blockage below the aortic valve.
See 3 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares a new drug called BHB-1893 to metoprolol, a standard medication, to see which works better for people with symptomatic obstructive hypertrophic cardiomyopathy. Participants are randomly assigned to one of the two treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BHB-1893Experimental Treatment1 Intervention
Group II: MetoprololActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Braveheart Bio, Inc.

Lead Sponsor

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