Cardiomyopathy, Hypertrophic ObstructivePhase 3LIONHEART-HCMNCT07755904
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Phase 3 study testing BHB-1893 and Metoprolol in people with Cardiomyopathy, Hypertrophic Obstructive, run by Braveheart Bio, Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiomyopathy, Hypertrophic Obstructive
- What is being tested?
- BHB-1893 and Metoprolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Sep 2026to Nov 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
LIONHEART-HCM Site 0107
Manhasset, New York, 11030
- Recruiting
LIONHEART-HCM Site 0121
Plano, Texas, 75024
- Recruiting
LIONHEART-HCM Site 0126
Rock Hill, South Carolina, 29732
About this study
Official 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
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.
- Conditions
- Cardiomyopathy, Hypertrophic Obstructive
- Being tested
- BHB-1893, Metoprolol
- Keywords
- oHCM, BHB-1893
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHB-1893Drug
Tablets for oral use
MetoprololDrug
Capsules for oral use
| Study group | Role | What they receive |
|---|---|---|
| BHB-1893 | Experimental | Participants will receive BHB-1893 twice daily and matching placebo for metoprolol once daily. Receives: Drug: BHB-1893 |
| Metoprolol | Active comparator | Participants will receive metoprolol once daily and matching placebo for BHB-1893 twice daily. Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
Measured: Baseline, Week 24
Secondary outcomes (5)
Change from Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)
Measured: Baseline, Week 24
Number of Participants with >=1 Class Improvement in New York Heart Association (NYHA) Class
Measured: Baseline to Week 24
Change from Baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Measured: Baseline, Week 24
Change from Baseline in Left Atrial Volume Index
Measured: Baseline, Week 24
Percent Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Concentration
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start2 Sep 2026
- Primary completionOct 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, Hypertrophic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braveheart Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755904
- Sponsor's protocol ID
- BHB-1893-301
- Other IDs
- 2026-526007-30-00
- Acronym
- LIONHEART-HCM
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No