A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy

NCT ID: NCT05414175

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-19
• Study Completion Date: 2026-03-06

Brief Summary

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).

Conditions

Cardiomyopathy, Hypertrophic Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mavacamten

Group Type: EXPERIMENTAL

Mavacamten

Intervention Type: DRUG

Specified dose on specified days

Interventions

Mavacamten

Specified dose on specified days

Intervention Type: DRUG

Other Intervention Names

BMS-986427; MYK-461

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0020

Uwajima, Ehime, Japan

Local Institution - 0026

Himeji-Shi, Hyōgo, Japan

Local Institution - 0016

Kobe, Hyōgo, Japan

Local Institution - 0017

Tsukuba, Ibaraki, Japan

Local Institution - 0023

Kanazawa, Ishikawa-ken, Japan

Local Institution - 0019

Yokohama, Kanagawa, Japan

Local Institution - 0015

Nankoku-shi, Kochi, Japan

Local Institution - 0028

Tsu, Mie-ken, Japan

Local Institution - 0027

Sendai, Miyagi, Japan

Local Institution - 0014

Suita, Osaka, Japan

Local Institution - 0011

Suita-Shi, Osaka, Japan

Local Institution - 0012

Hamamatsu, Shizuoka, Japan

Local Institution - 0010

Bunkyo-Ku, Tokyo, Japan

Local Institution - 0009

Chuo-Ku, Tokyo, Japan

Local Institution - 0003

Fuchu-Shi, Tokyo, Japan

Local Institution - 0001

Itabashi-Ku, Tokyo, Japan

Local Institution - 0007

Koto-Ku, Tokyo, Japan

Local Institution - 0005

Shinjuku-Ku, Tokyo, Japan

Local Institution - 0013

Shinjuku-ku, Tokyo, Japan

Local Institution - 0018

Osaka, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

Other Identifiers

CV027-004

Identifier Type: -

Identifier Source: org_study_id