ClinicalTrials.gg
RecruitingNCT07755904LIONHEART-HCMUpdated Nov 10, 2026

BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy

A Phase 3 interventional study of BHB-1893 and Metoprolol in Cardiomyopathy, Hypertrophic Obstructive, sponsored by Braveheart Bio, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Braveheart Bio, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Nov 10, 2026Now RecruitingFirst site in United States+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiomyopathy, Hypertrophic Obstructive

Keywords

  • oHCM
  • BHB-1893
03

In context

Cardiomyopathy, Hypertrophic

363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.

This study's planned enrollment of 210 is above the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

This is the only study on the registry with Braveheart Bio, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Diagnosed with oHCM per the protocol specified criteria
  • 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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    BHB-1893

    Participants will receive BHB-1893 twice daily and matching placebo for metoprolol once daily.

    Drug: BHB-1893

  • Active comparator
    Metoprolol

    Participants will receive metoprolol once daily and matching placebo for BHB-1893 twice daily.

    Drug: Metoprolol

Interventions

  • DrugBHB-1893

    Tablets for oral use

  • Capsules for oral use

06

What researchers measure

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

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

    Time frame: Baseline, Week 24

07

Study locations

4 of 4 sites recruiting
  • LIONHEART-HCM Site 0120
    Burlington, Massachusetts 01803, United States
    Recruiting
  • LIONHEART-HCM Site 0107
    Manhasset, New York 11030, United States
    Recruiting
  • LIONHEART-HCM Site 0126
    Rock Hill, South Carolina 29732, United States
    Recruiting
  • LIONHEART-HCM Site 0121
    Plano, Texas 75024, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 2, 2026
Sites
4 sites added — first site in United States
Show 4 added (4 United States)
  • LIONHEART-HCM Site 0107 · Manhasset, United States
  • LIONHEART-HCM Site 0126 · Rock Hill, United States
  • LIONHEART-HCM Site 0121 · Plano, United States
  • LIONHEART-HCM Site 0120 · Burlington, United States
across 2 updates, Oct 2, 2026 – Nov 10, 2026
Start date
Oct 31, 2026→Sep 2, 2026 (actual)
Oct 2, 2026
Contact
Study contact's phone or email changed: i•••@braveheart.bio→c•••@braveheart.bio. See the current contact
Nov 10, 2026
Show all 2 updates
  1. Nov 10, 2026
    1 site added
    Show site
    • LIONHEART-HCM Site 0120 · Burlington, United States
    Contact Study contact's phone or email changed: i•••@braveheart.bio→c•••@braveheart.bio. See the current contact
    + 1 other change: verification date
  2. Oct 2, 2026
    Not yet recruiting→Recruiting
    3 sites added — first site in United States
    Show 3 added (3 United States)
    • LIONHEART-HCM Site 0107 · Manhasset, United States
    • LIONHEART-HCM Site 0126 · Rock Hill, United States
    • LIONHEART-HCM Site 0121 · Plano, United States
    Start date Oct 31, 2026→Sep 2, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07755904
Lead sponsor
Braveheart Bio, Inc.
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Sep 2, 2026
Primary completion
Oct 2028 (estimated)
Completion
Nov 2028 (estimated)
Last update
Nov 10, 2026

Study contacts

Study Director
Contact
clinicaltrials@braveheart.bio
(415) 707-6312

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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