Ongoing Clinical Trials for Arrhythmogenic Right Ventricular Dysplasia
Three clinical trials are currently investigating new treatment approaches for arrhythmogenic right ventricular dysplasia, a heart condition that affects the heart muscle and can lead to irregular heartbeats. These studies are exploring medications that may help slow disease progression and protect heart function. Trials are taking place in France, Italy, and Poland. (Also known as: Arrhythmogenic Right Ventricular Cardiomyopathy, Arrhythmogenic Cardiomyopathy, ARVD, ARVC, ACM)
Clinical trial locations
- France
- Italy
- Poland
Study on Spironolactone for Patients with Arrhythmogenic Right Ventricular Dysplasia (ARVD)
This trial is investigating whether spironolactone, a medication commonly used to manage fluid retention, can help patients with arrhythmogenic right ventricular dysplasia. The study aims to evaluate if this drug can reduce the worsening of the right side of the heart and decrease irregular heartbeats.
Main inclusion criteria: To participate, you must be at least 18 years old and have a confirmed diagnosis based on specific medical criteria. Your right ventricle must show increased volume (more than 100 ml/m² for women or 110 ml/m² for men), and your left ventricular ejection fraction must be greater than 40%, which means your left side of the heart is still pumping reasonably well. You will need to provide written informed consent after understanding all aspects of the study.
Main exclusion criteria: You cannot participate if you fall outside the specified age range or belong to a vulnerable population that may be at higher risk of harm or cannot give proper informed consent.
Focus and goals: The study will last approximately one year and involves taking spironolactone tablets orally. Throughout the trial, your heart function will be monitored using echocardiography, which creates images of your heart using sound waves, and 24-hour Holter ECG monitoring, which records your heart’s electrical activity continuously. Follow-up assessments will occur at one year and three years to evaluate changes in your heart’s condition. The study is expected to conclude by September 2028.
Investigational drug: Spironolactone works by blocking certain hormones that can affect the heart and cause fluid retention. In this study, it is being tested at a dose of 25mg to see if it can protect the heart muscle and slow disease progression.
Study on the Effect of Atorvastatin in Slowing Down Arrhythmogenic Cardiomyopathy Progression in Patients with the Condition
This Italian trial is exploring whether atorvastatin, a drug typically used to lower cholesterol, can help prevent the progression of this heart condition. The researchers want to see if it can reduce or delay worsening of the heart’s right ventricle.
Main inclusion criteria: You must be 18 years or older and have a confirmed diagnosis based on the 2010 Task Force criteria. You will also need to sign an informed consent form showing you understand and agree to participate in the study.
Main exclusion criteria: The study excludes patients outside the specified age range, those who belong to vulnerable populations who cannot give proper consent or are in dependent relationships with study staff, and those who do not meet specific health criteria designed to ensure the safety and effectiveness of the study.
Focus and goals: Participants will receive atorvastatin in the form of 80mg film-coated tablets taken orally. The study includes a control group receiving a placebo for comparison. Regular assessments will monitor heart function using echocardiograms (ECHO) and other imaging tests, along with blood tests. The study will evaluate changes in heart structure, function, and rhythm to determine if atorvastatin can slow disease progression.
Investigational drug: Atorvastatin blocks an enzyme in the liver responsible for making cholesterol. By reducing cholesterol and inflammation, it may help improve heart function in people with this condition. The study is expected to conclude by August 31, 2026.
Study on Valsartan and Sacubitril for Preventing Disease Progression in Patients with Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
This Polish study is testing Entresto, a combination medication containing valsartan and sacubitril, to see if it can prevent disease progression by reducing strain on the heart and preventing tissue scarring.
Main inclusion criteria: You must be older than 18 years with a confirmed diagnosis based on specific 2010 criteria. Your left ventricular ejection fraction must be at least 40%, meaning your heart’s left side maintains reasonable pumping ability. You will need to sign a written consent form to participate.
Main exclusion criteria: The study excludes patients with severe allergic reactions to the study medication, severe kidney problems requiring dialysis, severe liver disease, those who are pregnant or breastfeeding, recent participation in another clinical trial (within 30 days), history of drug or alcohol abuse within the past year, uncontrolled high blood pressure, recent heart attack, inability to follow study procedures, or any other medical condition that doctors believe would make participation unsafe.
Focus and goals: Participants will take Entresto orally in the form of film-coated tablets, with dosages ranging from 24mg/26mg to 97mg/103mg depending on individual needs. The study lasts up to 48 weeks, during which participants will be randomly assigned to receive either the medication or a placebo. Throughout the trial, various tests including Cardiac Magnetic Resonance (CMR) and Electrocardiogram (ECG) will monitor heart health. The study will assess changes in heart muscle structure, particularly focusing on fibrosis (scarring), heart function, and the occurrence of irregular heartbeats.
Investigational drug: Sacubitril/valsartan combines two active ingredients that work together: sacubitril inhibits an enzyme called neprilysin, while valsartan blocks angiotensin II receptors. Together, they help reduce fibrosis and remodeling of heart tissue, potentially improving heart function. This study is expected to conclude by April 2029.
Summary
Three clinical trials are currently underway in Europe investigating different medication approaches for managing arrhythmogenic right ventricular dysplasia. Each trial is being conducted in a different country—France, Italy, and Poland—reflecting international interest in finding effective treatments for this condition.
The trials are testing three distinct medications: spironolactone (a hormone blocker and diuretic), atorvastatin (a cholesterol-lowering statin), and sacubitril/valsartan (a combination heart failure medication). While these drugs were originally developed for other heart conditions, researchers believe they may help slow disease progression by protecting heart muscle, reducing inflammation, preventing tissue scarring, and improving heart function.
All three studies share common goals of preventing disease progression and maintaining heart function, though they use different approaches and monitoring methods. Each trial involves regular heart monitoring through imaging techniques and will compare the investigational medication against a placebo to determine effectiveness. The studies are expected to conclude between 2026 and 2029, providing valuable information about potential treatment options for people living with this condition.
