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MYK-224 for Hypertrophic Cardiomyopathy (MERCUTIO Trial)

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New York Heart Association (NYHA) functional class II or III symptoms at screening.

Men or women diagnosed with oHCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines, satisfying both of the following criteria:

Must not have

Prior treatment with cardiotoxic agents such as anthracyclines (eg, doxorubicin) or similar

Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with left ventricular hypertrophy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the safety, effectiveness, and how the body processes a new drug for Obstructive Hypertrophic Cardiomyopathy (oHCM).

Who is the study for?

This trial is for men and women with obstructive Hypertrophic Cardiomyopathy (oHCM) who have symptoms, a thickened heart wall, and specific heart function criteria. They must be able to undergo exercise stress testing and not have had certain recent cardiac procedures or treatments.

What is being tested?

The study tests MYK-224's effects on people with oHCM. It aims to understand how safe it is, how well it works, what the body does to the drug (pharmacokinetics), and how the drug affects the body (pharmacodynamics).

What are the potential side effects?

While specific side effects of MYK-224 are not listed here, common ones in trials may include nausea, headache, dizziness, fatigue or allergic reactions. The trial will monitor participants closely for any adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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I experience mild to moderate heart symptoms.

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I have been diagnosed with obstructive hypertrophic cardiomyopathy according to current guidelines.

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My heart screening showed a specific high pressure reading.

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My heart's pumping ability is normal or above normal.

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My heart has thick walls without dilation, not caused by other known diseases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with heart-damaging drugs like doxorubicin.

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I have a condition like Fabry disease or amyloidosis that causes thickening of the heart muscle.

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I have had or will have an ICD placed or changed recently.

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I have had heart issues with reduced pumping efficiency.

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I have lung problems that make me short of breath when I exert myself.

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I have irregular heartbeats that come and go, confirmed by an ECG.

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I have a history of sudden cardiac arrest or my ICD activated due to a severe heart rhythm issue in the last 6 months.

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I have a health condition that prevents me from doing exercise stress tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

Participants will receive MYK-224 in combination with standard-of-care consisting of either a calcium channel blocker or disopyramide (which is given in combination with either a beta-blocker or calcium channel blocker). Participants who complete Cohort 2 will be eligible for an optional open label extension period

Group II: Cohort 1Experimental Treatment1 Intervention

Participants will receive MYK-224 either as a monotherapy or in combination with standard-of-care consisting of a beta-blocker. Participants who complete Cohort 1 will be eligible for an optional open label extension period

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MYK-224

2023

Completed Phase 1

~90

0 / 13Eligibility criteria met