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MYK-224 for Hypertrophic Cardiomyopathy (MERCUTIO Trial)
Phase 2
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
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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 53 weeks
Awards & highlights
MERCUTIO Trial 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.Check my eligibility
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).See study design
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.
MERCUTIO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience mild to moderate heart symptoms.
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I have been diagnosed with obstructive hypertrophic cardiomyopathy according to current guidelines.
Select...
My heart screening showed a specific high pressure reading.
Select...
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.
MERCUTIO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 53 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 53 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Cardiac Arrest
Cardiac Arrhythmia
+5 moreSecondary outcome measures
Change in left ventricular outflow tract (LVOT) peak gradient (post-exercise, resting, and Valsalva) from baseline to end of treatment
Concentration-response relationship between MYK-224 PK and echocardiographic parameters of systolic and diastolic function
Concentration-response relationship between MYK-224 pharmacokinetics (PK) and LVOT peak gradients
+2 moreMERCUTIO 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
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,640 Previous Clinical Trials
4,129,428 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience mild to moderate heart symptoms.I have been treated with heart-damaging drugs like doxorubicin.I have had or will have an ICD placed or changed recently.I have had heart issues with reduced pumping efficiency.I have been diagnosed with obstructive hypertrophic cardiomyopathy according to current guidelines.I have a condition like Fabry disease or amyloidosis that causes thickening of the heart muscle.I have lung problems that make me short of breath when I exert myself.I had or plan to have heart surgery or a procedure to improve blood flow within the last 6 months.My heart screening showed a specific high pressure reading.Your heart's peak gradient was measured after exercise and needs to be within a certain range.Your heart can be clearly seen and examined using an ultrasound test.I have irregular heartbeats that come and go, confirmed by an ECG.Your heart's electrical activity, called QT interval, is too long and may be risky for your safety.My doctor says I have moderate to severe narrowing of my aortic valve.My heart's pumping ability is normal or above normal.I have a history of sudden cardiac arrest or my ICD activated due to a severe heart rhythm issue in the last 6 months.I have had heart issues but any procedures were done over 12 weeks ago.My heart has thick walls without dilation, not caused by other known diseases.I have atrial fibrillation not treated with blood thinners for 4 weeks or not controlled in the last 6 months.I have a health condition that prevents me from doing exercise stress tests.I have had fainting spells or rapid heartbeats in the last 6 months.I haven't taken mavacamten or aficamten recently, or it's been over 4 months since I last did.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age limit to participate in the trial?
"This clinical trial has specific requirements in regards to age; the lower limit is 18, while the upper limit lies at 70 years old."
Answered by AI
What is the current extent of participants in this research endeavor?
"Affirmative. According to the details posted on clinicaltrials.gov, this ongoing research is actively seeking applicants. The trial has been running since January 18th 2023 and was last modified on February 6th 2023; 36 patients are needed from 4 different sites."
Answered by AI
Are any new participants being enrolled for this research trial?
"Affirmative. Clinicaltrials.gov has records of this medical trial which was posted on January 18th 2023 and updated February 6th 2023, indicating that it is still recruiting with a need for 36 participants across 4 sites."
Answered by AI
Has Cohort 2 received the stamp of approval from the Federal Drug Administration?
"Cohort 2 has a safety rating of 2, implying that while there is some data supporting its safety, none exists to support efficacy."
Answered by AI
In what capacity are medical facilities conducting this clinical experiment in the city?
"Currently, the recruitment process is taking place at 4 sites across Boise, Kansas City and New york. To minimize any potential travel considerations, it would be prudent to select a clinic nearest your residence."
Answered by AI
Am I eligible to join this clinical trial?
"This medical trial is currently accepting applications from 36 patients, aged 18 to 70, with a diagnosis of hypertrophic cardiomyopathy. Furthermore, these candidates must have an LV wall thickness ≥ 15 millimeters (or 13+ mm if there is a family history or known mutation), NYHA class II/III symptoms at screening, adequate acoustic windows for accurate TTEs as determined by echocardiography core lab analysis, and resting LVOT peak gradient ≥ 50 mm Hg or 30+ mmHg after Valsalva maneuver plus LVEF ≥ 60% upon screening."
Answered by AI
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