Ongoing Clinical Trials for Non-obstructive Cardiomyopathy
There is currently 1 ongoing clinical trial for non-obstructive hypertrophic cardiomyopathy, testing a medication called Mavacamten to improve symptoms and exercise capacity in adults with this heart condition. The study is being conducted across multiple European countries and aims to evaluate whether this treatment can enhance quality of life for people living with this form of thickened heart muscle.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Germany
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Portugal
- Spain
Study on Mavacamten for Adults with Non-obstructive Hypertrophic Cardiomyopathy
This study focuses on a heart condition where the heart muscle becomes abnormally thick without blocking blood flow, which can make it harder for the heart to pump blood efficiently. The trial is testing a medication called Mavacamten, taken as a capsule, to see if it can improve symptoms and physical abilities in people living with this condition.
Who can participate:
- Adults aged 18 or older
- People diagnosed with hypertrophic cardiomyopathy following specific medical guidelines
- Individuals with heart symptoms classified as New York Heart Association Class II or III, which means they experience some limitation during ordinary physical activity
- Those who can perform a cardiopulmonary stress test, which measures how well the heart and lungs work during exercise
- Participants must have specific blood test results showing NT-proBNP levels of 200 pg/mL or higher, or BNP levels of 70 pg/mL or higher, which help measure heart function
- Heart function measured by left ventricular ejection fraction must be 60% or higher
- The Kansas City Cardiomyopathy Questionnaire score, which measures impact on daily life, must be 85 or lower
- Female participants must use effective birth control or provide proof they cannot have children
Who cannot participate:
- People with other types of heart conditions not related to this specific form of thickened heart muscle
- Individuals outside the specified age range
- Those unable to follow study procedures or take the medication as required
- People with certain medical conditions or taking medications that might interfere with the study treatment
- Pregnant or breastfeeding women
- Those who recently participated in another clinical trial
- Individuals with a history of drug or alcohol abuse that could affect their ability to follow study requirements
- Anyone with known allergies to the study medication or similar drugs
What the study involves:
The trial lasts for 48 weeks and is designed as a double-blind study, meaning neither participants nor researchers know who is receiving the active medication versus a placebo. Upon joining, participants are randomly assigned to receive either Mavacamten or a placebo capsule taken orally.
Throughout the study, participants will have regular check-ups to monitor their health status, symptoms, and exercise capacity. The main outcomes being measured include changes in quality of life scores and peak oxygen consumption during exercise. Secondary outcomes include improvements in symptom classification, changes in heart-related biomarkers, and tracking of any major cardiovascular events.
The investigational drug:
Mavacamten works by inhibiting cardiac myosin, a protein involved in heart muscle contraction. By reducing excessive contraction, it aims to improve heart function and reduce symptoms like shortness of breath and limited exercise capacity. This medication is being studied specifically for its potential to help people with symptomatic non-obstructive hypertrophic cardiomyopathy improve their physical abilities and overall quality of life.
Summary
Currently, there is one active clinical trial for non-obstructive hypertrophic cardiomyopathy available across 13 European countries, including Italy, Poland, Hungary, Denmark, Czechia, Austria, Portugal, Germany, Spain, Norway, Belgium, Netherlands, and France. This wide geographical distribution provides access to the study for many European patients living with this condition.
The trial focuses exclusively on testing Mavacamten, a cardiac myosin inhibitor that works differently from traditional heart medications by directly targeting the heart muscle’s contraction mechanism. The study aims to determine whether this treatment approach can meaningfully improve both objective measures like exercise capacity and subjective experiences like quality of life for people with symptomatic non-obstructive hypertrophic cardiomyopathy.
The 48-week duration of the study allows researchers to assess both short-term symptom improvements and longer-term safety and effectiveness of the medication. For patients interested in participating, the trial offers an opportunity to access a potentially beneficial treatment while contributing to medical knowledge about this specific form of heart disease.
