Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)

NCT07541833 | Recruiting FDA Drug

• 1 other identifier: CV027-1233
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan

Conditions

Cardiomyopathy

Keywords

hypertrophic cardiomyopathy (HOCM)

Outcome Measures

Primary Outcomes (1)

• Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment

  Baseline and up to week 16

Secondary Outcomes (25)

• Change in Left Ventricular Outflow Tract (LVOT) peak gradient (resting and Valsalva maneuver)

  Baseline and up to week 16

• Proportion of patients achieving target Left Ventricular Outflow Tract (LVOT) peak gradients (<50 mmHg / <30 mmHg) (Valsalva maneuver or post-exercise)

  Baseline and up to week 16

• Proportion of patients with any decrease in resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradients

  Baseline and up to week 16

• Proportion of patients with ≥1 New York Heart Association (NYHA) functional class improvement

  Baseline and up to week 16

• Change in cardiac biomarkers from baseline

  Baseline and up to week 16

Study Arms (2)

Switch Group

Participants who discontinue cibenzoline before or at the initiation of mavacamten treatment

Drug: Mavacamten

Tapering/Add-on Group

Participants who continue cibenzoline at the initiation of mavacamten treatment

Drug: Mavacamten

Interventions

Mavacamten DRUG

According to the product label

Switch Group; Tapering/Add-on Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) who have been prescribed mavacamten treatment by the treating physician as part of routine clinical care, in Japan

You may qualify if:

• Signed informed consent form (ICF): Participants, or their legally acceptable representative, must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF in accordance with regulatory, local, and institutional guidelines. This must be obtained before the performance of any protocol-related procedures.
• Diagnosed with obstructive hypertrophic cardiomyopathy (HOCM) consistent with Japanese Circulation Society guidelines (2025), i.e., satisfy all criteria below:
• Has unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (e.g., hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of HCM).
• Has Left Ventricular Outflow Tract (LVOT) peak gradient ≥ 30 mmHg (resting, Valsalva maneuver, or post-exercise).
• Has documented Left Ventricular Ejection Fraction (LVEF) ≥ 55% at baseline.
• Participants who meet any of the following criteria:
• Participants who have previously received mavacamten continuously for ≥ 16 weeks
• Participants who are currently receiving mavacamten
• Participants who are scheduled to receive mavacamten
• Treated with a stable dose of cibenzoline for at least 3 months prior to initiating mavacamten treatment. Tapered cibenzoline within 3 months prior to initiating mavacamten treatment is allowed if stable dose of cibenzoline was used for at least 3 months prior to tapering.
• At least 18 years of age at the time of signing the informed consent.

You may not qualify if:

• Hypersensitivity to the active substance or to any of the excipients.
• During pregnancy and in women of childbearing potential.
• Treated with strong CYP3A4 inhibitors (itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir, cobicistat, ceritinib, ensitrelvir fumaric acid, lonafarnib, josamycin, or mifepristone/misoprostol).
• Severe hepatic impairment (Child-Pugh C).
• Severe atrioventricular block or severe sinoatrial block.
• Congestive heart failure.
• Requiring dialysis.
• Angle-closure glaucoma.
• Tendency to urinary retention.
• Treated with vardenafil hydrochloride hydrate, moxifloxacin hydrochloride, lascufloxacin hydrochloride (injection), toremifene citrate, fingolimod hydrochloride, siponimod fumarate, or eliglustat tartrate.
• Mavacamten treatment within 8 weeks prior to baseline. Mavacamten treatment initiation was judged based on post-exercise LVOT peak gradient.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Kochi University

Kochi, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Cardiomyopathies; Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristo Myers Squibb

  Bristo Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 21, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)