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Myosin Inhibitor

Mavacamten for Hypertrophic Cardiomyopathy (MEMENTO Trial)

Phase 4
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM), in accordance with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines as below: Left ventricular outflow tract (LVOT) peak gradient ≥ 30 mm Hg and ≥ 50 mm Hg after Valsalva or after exercise, Left ventricular ejection fraction (LVEF) ≥ 55% at rest, New York Heart Association (NYHA) functional class II or III symptoms
Be older than 18 years old
Must not have
A known infiltrative or storage disorder causing cardiac hypertrophy that mimics oHCM
Documented obstructive coronary artery disease or history of myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 48
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests how a new drug affects the heart's structure in adults with a heart condition called oHCM.

Who is the study for?
This trial is for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), specifically those who experience certain levels of heart blockage and have a normal or near-normal heart pumping function. They should be somewhat limited in their physical activity but not bedridden. People with recent severe cardiac events, pacemakers, conditions that look like oHCM, or major artery blockages can't join.
What is being tested?
The study tests the effects of Mavacamten on the heart's structure using advanced imaging techniques in people with oHCM. Participants will either receive Mavacamten or a placebo to compare outcomes between the two groups.
What are the potential side effects?
While specific side effects for this trial are not listed, common side effects of drugs like Mavacamten may include dizziness, changes in blood pressure and heartbeat, fatigue, and potential impact on liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific heart condition (oHCM) that meets certain criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that causes thickening of the heart muscle, similar to oHCM.
Select...
I have had a heart attack or have been diagnosed with blocked arteries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48

Side effects data

From 2024 Phase 3 trial • 112 Patients • NCT04349072
9%
Fatigue
8%
Dizziness
7%
Headache
6%
Dyspnoea
6%
Palpitations
6%
Dyspnoea exertional
6%
Hypertension
6%
Arthralgia
3%
Atrial fibrillation
1%
Peripheral venous disease
1%
Cardiac failure congestive
1%
Acute respiratory failure
1%
Gastrooesophageal reflux disease
1%
Sudden cardiac death
1%
Fall
1%
Large intestine perforation
1%
Pneumatosis intestinalis
1%
Nephrolithiasis
1%
Pulmonary embolism
1%
COVID-19
1%
Clostridium difficile infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mavacamten
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MavacamtenExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavacamten
2022
Completed Phase 3
~530

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,686 Previous Clinical Trials
4,129,776 Total Patients Enrolled
~57 spots leftby Jul 2026
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