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Study on the Effects of MYK-224 for Patients with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a heart condition known as Hypertrophic Cardiomyopathy, which is characterized by the thickening of the heart muscle. Specifically, the study looks at cases where this thickening leads to a blockage in the heart's blood flow, known as Left Ventricular Outflow Tract Obstruction. The treatment being tested is a medication called MYK-224, which is taken in tablet form. The purpose of the study is to evaluate the safety and how well patients tolerate this medication.

Participants in the study will receive multiple doses of MYK-224 over a period of time. The study will monitor how the body processes the medication and its effects on the heart condition. Participants will be observed for any side effects and changes in their heart function. The study is designed to gather information on how effective the medication is in treating the symptoms of Hypertrophic Cardiomyopathy and improving the heart's ability to pump blood.

The study is divided into two parts. In the first part, participants will receive the medication and be closely monitored. Those who complete the first part may have the option to continue into the second part, which is an extended study lasting up to two years. Throughout the study, participants will undergo regular check-ups, including heart function tests, to ensure their safety and to collect data on the medication's effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria related to heart health and function.
Participants must have a diagnosis of obstructive hypertrophic cardiomyopathy (oHCM) and meet certain heart function measurements.
Step 2
Part a: initial treatment phase
Participants receive the medication MYK-224 in the form of a tablet taken orally.
The purpose of this phase is to evaluate the safety and tolerability of the medication.
Regular assessments are conducted to monitor heart function and overall health.
Step 3
Monitoring and assessments
Throughout the trial, participants undergo various tests including echocardiograms and electrocardiograms to assess heart function.
Vital signs and physical health are regularly checked to ensure participant safety.
Step 4
Completion of part a
After completing Part A, participants are evaluated to determine if they can proceed to Part B.
Eligibility for Part B is based on the completion of assessments and overall health status.
Step 5
Part b: extension phase
Participants who qualify may enter Part B, which is an optional 2-year extension of the study.
This phase continues to monitor the long-term effects and safety of MYK-224.
Step 6
End of study
The study is estimated to conclude by October 2027.
Final assessments are conducted to gather comprehensive data on the medication's effects.

Who can join the trial?

8 criteria

Participants must have **adequate acoustic windows**. This means that the heart can be clearly seen using a special ultrasound test called echocardiography.
Both men and women can participate if they have been diagnosed with **obstructive Hypertrophic Cardiomyopathy (oHCM)**. This is a heart condition where the heart muscle is thicker than normal, making it harder for blood to leave the heart.
The heart's **left ventricular (LV) wall** must be at least 15 millimeters thick, or at least 13 millimeters if there is a family history of the condition or a known genetic mutation causing it.
The **LVOT peak gradient**, which is a measure of pressure in the heart, must be at least 50 millimeters of mercury at rest, or at least 30 millimeters at rest and 50 millimeters after a special breathing technique called the Valsalva maneuver.
The heart's **left ventricular ejection fraction (LVEF)**, which shows how well the heart pumps blood, must be at least 60% at the screening visit.
Participants must have a valid measurement of the **LVOT post-exercise peak gradient** at screening.
Participants should have **NYHA functional class II or III symptoms**. This means they have some limitations in physical activity due to heart symptoms.
Participants who complete Part A of the study may join Part B, which is an optional 2-year extension of the study.

Who cannot join the trial?

9 criteria

Patients who have a different heart condition than the one being studied.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other serious health issues that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent heart surgery or procedure.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to give informed consent to participate in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Verified
Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
Responsive
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland

Trial locations

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Investigated drugs

MYK-224 is an investigational medication being studied for its potential to help people with symptomatic hypertrophic cardiomyopathy, a condition where the heart muscle becomes abnormally thick. This thickening can make it harder for the heart to pump blood. The trial aims to evaluate how safe and tolerable MYK-224 is for patients, as well as how it behaves in the body and its effects on the heart condition.

Bms-986435

What is already known about the treatment

MYK-224 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety. It is primarily being investigated for the treatment of symptomatic hypertrophic cardiomyopathy, a condition characterized by thickened heart muscle, and left ventricular outflow tract obstruction. MYK-224 works by modulating the function of cardiac myosin, a protein involved in heart muscle contraction, to improve heart function. It is classified as a cardiac myosin inhibitor, and its development is ongoing to determine its potential benefits and risks in treating heart conditions.

Investigated diseases

Hypertrophic Cardiomyopathy – This is a condition where the heart muscle becomes abnormally thick, making it harder for the heart to pump blood. The thickening often occurs in the septum, the wall dividing the left and right sides of the heart, which can obstruct blood flow out of the heart. Symptoms may include chest pain, shortness of breath, and palpitations, especially during physical activity. Over time, the heart may struggle to maintain normal function, leading to symptoms of heart failure. The condition can also cause arrhythmias, which are irregular heartbeats that can be felt as palpitations. In some cases, the thickened heart muscle can lead to problems with the heart's electrical system, increasing the risk of sudden cardiac events.