A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

- Diagnosis of HCM consistent with current American College of Cardiology
Foundation/American Heart Association and European Society of Cardiology guidelines:
unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the
absence of other cardiac or systemic disease which can produce the required magnitude
of hypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm)
(or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as
determined by core laboratory interpretation.

- Peak left ventricular outflow tract (LVOT) pressure gradient < 30 millimeters mercury
(mm Hg) at rest and < 50 mm Hg with provocation (Valsalva maneuver and stress
echocardiography).

- New York Heart Association (NYHA) Class II or III.

Exclusion Criteria

- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics
non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis,
or Noonan syndrome with LV hypertrophy.

- History of unexplained syncope within 6 months prior to screening.

- History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior
to screening.

- Other protocol-defined Inclusion/Exclusion criteria apply.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/7/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Geske, M.D.

Closed for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Said Alsidawi, M.D.

Closed for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
.
CLS-20549246

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