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NCT06112743 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Phase 4 study of Cardiomyopathy, Hypertrophic, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 4
- Development phase
- 63
- Enrollment target
- 20
- Study locations
NCT06112743: Active Phase 4 study of Cardiomyopathy, Hypertrophic, sponsored by Bristol-Myers Squibb.
NCT06112743 is a Phase 4 study of Cardiomyopathy, Hypertrophic that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 63 participants, below the 363-participant average among 6 other Cardiomyopathy, Hypertrophic trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06112743, a Phase 4 study of Cardiomyopathy, Hypertrophic, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 63 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) \[New York Heart Association (NYHA) Functional Class II or III\].
Primary Outcome
Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment: * A decrease of at least 5 mL/m2 in maximum LAVI from baseline * A decrease of at least 5 g/m2 in LVMI from baseline
Conditions Studied
Interventions
- DRUG Mavacamten
Study Locations (20)
Buenos Aires
- Local Institution - 0076 - Ciudad Autónoma de Buenos Aires
- Local Institution - 0075 - Ciudad Autónoma de Buenos Aires
- Local Institution - 0079 - Pilar
Quebec
- Local Institution - 0001 - Montreal
- Local Institution - 0068 - Québec
California
- Local Institution - 0087 - West Hollywood
Georgia
- Local Institution - 0003 - Atlanta
Massachusetts
- Local Institution - 0093 - Boston
Ohio
- Local Institution - 0090 - Cleveland
Pennsylvania
- Local Institution - 0086 - Pittsburgh
Texas
- Local Institution - 0017 - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2026-07-09 |
| Phase | Phase 4 |
What the registry record for NCT06112743 still lists
NCT06112743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 363-participant average among 6 other Cardiomyopathy, Hypertrophic trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Cardiomyopathy, Hypertrophic appearing as the primary indexed condition, and to 1 intervention - of which Mavacamten is the first listed.
NCT06112743 names 20 study sites across 17 states, led by Buenos Aires, Quebec, California.
Frequently Asked Questions
What is clinical trial NCT06112743 about?
NCT06112743 is a clinical study titled "A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy". The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) \[New York Heart Association (NYHA) Functional Class II or III\].
What is the current status of trial NCT06112743?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2024-01-24. Estimated completion is 2026-07-09.
What conditions does trial NCT06112743 study?
This clinical trial studies the following conditions: Cardiomyopathy, Hypertrophic.
What interventions are being tested in trial NCT06112743?
The interventions under investigation include: Mavacamten (DRUG).
Who is sponsoring clinical trial NCT06112743?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06112743 being conducted?
This trial has 20 study locations across California, Georgia, Massachusetts, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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