A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy (HORIZON-HCM)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Treatments

Drug: Mavacamten

Study type

Interventional

Funder types

Industry

Identifiers

NCT05414175

CV027-004

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a 30-week course of mavacamten and the long-term effects of mavacamten in Japanese participants with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18 and greater, body weight ≥ 35kg
Has adequate acoustic windows to enable accurate transthoracic echocardiograms (TTEs)
Diagnosed with obstructive hypertrophic cardiomyopathy consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Japanese Circulation Society guidelines
Has documented left ventricular ejection fraction (LVEF) ≥60% NYHA Class II or III

Exclusion criteria

Known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to Screening
History of resuscitated sudden cardiac arrest (at any time) or known history of appropriate implantable cardioverter defibrillator (ICD) discharge for life-threatening ventricular arrhythmia within 6 months prior to Screening
Paroxysmal atrial fibrillation with atrial fibrillation present at the time of Screening.
Persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
Treatment (within 14 days prior to Screening) or planned treatment during the study with cibenzoline, disopyramide or ranolazine
Treatment (within 14 days prior to Screening) or planned treatment during the study with a combination of beta blockers and verapamil or a combination of beta blockers and diltiazem
Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to Screening or plans to have either of these treatments during the study
ICD placement within 2 months prior to Screening or planned ICD placement during the study
Has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety or interfere with the study evaluation procedures, or completion
Prior treatment with cardiotoxic agents such as doxorubicin or similar