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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 48

Awards & highlights

MEMENTO 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.Check my eligibility

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.See study design

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.

MEMENTO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a specific heart condition (oHCM) that meets certain criteria.

MEMENTO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 48

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48

Secondary outcome measures

All-cause mortality

Change from baseline in left atrial volume index (LAVI) at Week 48

Change from baseline in left ventricular mass index (LVMI) at Week 48

+15 more

MEMENTO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MavacamtenExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mavacamten

2022

Completed Phase 1

~340

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,964 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration given its stamp of approval for Mavacamten?

"The safety of Mavacamten is rated 3 out of 3 due to its FDA-approval status and Phase 4 trial standing."

Answered by AI

Are any of the research sites for this project situated in North America?

"Currently, 10 medical centres are enrolling patients in this research. These locations span from Honolulu to Boston and Cleveland. If you choose to take part, it is prudent to select the closest centre available so as to reduce travel cost and stress."

Answered by AI

Is enrollment for this trial open at the moment?

"This medical trial, posted on November 20th 2021 and last updated on October 27th 2021 is no longer recruiting patients. Nevertheless, 237 other studies are actively looking for participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

2024. "A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112743.

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