Hypertrophic Cardiomyopathy Clinical Trial

A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

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].

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below:
Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mm Hg and ≥ 50 mm Hg after Valsalva or after exercise
Left ventricular ejection fraction (LVEF) ≥ 55% at rest
New York Heart Association (NYHA) functional class II or III symptoms

Exclusion Criteria:

A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM
Documented obstructive coronary artery disease or history of myocardial infarction
A history of resuscitated sudden cardiac arrest or life-threatening ventricular arrhythmia within 6 months prior to screening
An implantable cardioverter defibrillator (ICD) or pacemaker, or another contraindication for cardiac magnetic resonance imaging (CMR)

Note: Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 4

Estimated Enrollment:

100

Study ID:

NCT06112743

Recruitment Status:

Not yet recruiting

Sponsor:

Bristol-Myers Squibb

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There are 16 Locations for this study

See Locations Near You

Cedars Sinai Medical Center
West Hollywood California, 90048, United States More Info
Florian Rader, Site 0087
Contact
310-967-3846
Piedmont Hospital
Atlanta Georgia, 30309, United States More Info
Rahul Loungani, Site 0003
Contact
803-553-1103
Queen's Heart Institute Honolulu
Honolulu Hawaii, 96813, United States More Info
Dipanjan Banerjee, Site 0091
Contact
650-533-2433
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Albree Tower-Rader, Site 0093
Contact
617-724-5434
University Hospitals Cleveland Medical Center - 11100 Euclid Ave
Cleveland Ohio, 44106, United States More Info
Imran Rashid, Site 0090
Contact
216-844-3800
Allegheny General Hospital
Pittsburgh Pennsylvania, 15224, United States More Info
Victor Farah, Site 0086
Contact
901-484-8358
Local Institution - 0082
Darlinghurst New South Wales, 2010, Australia
Local Institution - 0028
Graz , 8036, Austria More Info
Site 0028
Contact
Local Institution - 0088
Wien , 1090, Austria More Info
Site 0088
Contact
Local Institution - 0092
Genk Limburg, 3600, Belgium More Info
Site 0092
Contact
Local Institution - 0071
Roeselare West-Vlaanderen, 8800, Belgium More Info
Site 0071
Contact
Local Institution - 0004
Calgary Alberta, T2N 1, Canada
Local Institution - 0050
Prague Praha, Hlavní Mesto, 140 2, Czechia
Local Institution - 0089
Madrid , 28034, Spain More Info
Site 0089
Contact
Local Institution - 0036
Bern , 3010, Switzerland
Local Institution - 0061
Geneva , 1205, Switzerland More Info
Site 0061
Contact

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 4

Estimated Enrollment:

100

Study ID:

NCT06112743

Recruitment Status:

Not yet recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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