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MEMENTO-A Phase 3b/4 Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to assess the impact on Myocardial Structure with Cardiac Magnetic Resonance Imaging (CMR)

Status
Completed
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502316-36-00
Acronym
CV0271088
Enrollment
105
Registered
2024-02-06
Start date
Unknown
Completion date
2024-03-15
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Obstructive Hypertrophic Cardiomyopathy

Brief summary

To evaluate the efficacy of mavacamten on both the reduction in heart wall thickness and upper chamber size at week 48 on cardiac magnetic resonance (CMR).

Detailed description

To evaluate the impact of mavacamten treatment: on improvement of heart failure class in symptomatic oHCM (New York Heart Association [NYHA] Functional Class) as well as monitor for other cardiac events as a safety assessment.

Interventions

DRUGMavacamten
DRUGPlacebo is a solid oral dosage form in size 2 gelatin capsules each containing 120 mg of an excipient blend. It is intended as a placebo to match MYK-461 Capsules of all active strengths"

Sponsors

Myokardia Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of mavacamten on both the reduction in heart wall thickness and upper chamber size at week 48 on cardiac magnetic resonance (CMR).

Secondary

MeasureTime frame
To evaluate the impact of mavacamten treatment: on improvement of heart failure class in symptomatic oHCM (New York Heart Association [NYHA] Functional Class) as well as monitor for other cardiac events as a safety assessment.

Countries

Austria, Belgium, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026