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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07755904
- Acronym / sponsor ID
- LIONHEART-HCM / BHB-1893-301
- Conditions
- Cardiomyopathy, Hypertrophic Obstructive
- Keywords
- oHCM, BHB-1893
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Braveheart Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHB-1893 | Experimental | Drug: BHB-1893Participants will receive BHB-1893 twice daily and matching placebo for metoprolol once daily. |
| Metoprolol | Active comparator | Drug: MetoprololParticipants will receive metoprolol once daily and matching placebo for BHB-1893 twice daily. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHB-1893Tablets for oral use | Drug | BHB-1893 |
| MetoprololCapsules for oral use | Drug | Metoprolol |
Primary outcome
Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
Time frame: Baseline, Week 24
5 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director ((415) 707-6312, info@braveheart.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.