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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

Qualifiers

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 have previously received mavacamten continuously for ≥ 16 weeks

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Mavacamten

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Mebix. IncRecruiting1050001, Minato-ku, TokyoJapanJapan

Sponsors and collaborators