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Study on Spironolactone for Patients with Arrhythmogenic Right Ventricular Dysplasia (ARVD)

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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 Arrhythmogenic Right Ventricular Dysplasia (ARVD). This condition affects the heart's ability to pump blood effectively and can lead to irregular heartbeats. The study will use a medication called Spironolactone, which is taken in the form of tablets. Spironolactone is a type of medication that helps to block certain hormones that can affect the heart.

The purpose of the study is to evaluate how well Spironolactone can help reduce the worsening of the right side of the heart and decrease irregular heartbeats in patients with ARVD. Participants in the study will be randomly assigned to receive either Spironolactone or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for about one year, during which participants will have regular check-ups and tests to monitor their heart's condition.

Throughout the study, participants will undergo tests such as echocardiography, which uses sound waves to create images of the heart, and a 24-hour Holter ECG, a device that records the heart's electrical activity over a full day. These tests will help doctors see how the heart is functioning and if there are any changes in heart rhythm. The study aims to provide valuable information on the effectiveness of Spironolactone in managing ARVD and improving heart health.

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, you will be asked to provide written consent, confirming your understanding and agreement to participate in the trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of arrhythmogenic right ventricular dysplasia (ARVD) and ensuring you meet the necessary criteria, such as being 18 years or older and having specific heart measurements.
Step 3
Medication administration
You will be given spironolactone 25mg tablets to take orally. The dosage and frequency will be determined by the study protocol, and you will be instructed on how to take the medication correctly.
Step 4
Regular monitoring
Throughout the study, your heart function will be monitored using echocardiography and a 24-hour Holter ECG. These tests will help assess any changes in your heart's condition over time.
Step 5
Follow-up assessments
Follow-up assessments will occur at regular intervals, including at one year and three years after starting the trial. These assessments will evaluate your heart's function and any changes in your condition.
Step 6
End of study
At the end of the study, a final assessment will be conducted to determine the overall impact of the medication on your heart condition. The study is expected to conclude by September 2028.

Who can join the trial?

5 criteria

Adult patient aged 18 years or older.
Diagnosis of Arrhythmogenic Right Ventricular Dysplasia (ARVD) based on specific criteria. This includes either two major criteria (one related to heart structure and one related to heart rhythm) or one major and two minor criteria as established by heart health organizations.
Increased right ventricular volume, which means the right side of the heart is larger than normal. For women, this is more than 100 ml/m², and for men, more than 110 ml/m².
Left Ventricular Ejection Fraction (LVEF) greater than 40%. LVEF is a measure of how well the left side of the heart pumps blood with each beat.
Signed written informed consent, meaning the patient has read and agreed to participate in the study after understanding all the details.

Who cannot join the trial?

3 criteria

Patients with **arrhythmogenic right ventricular dysplasia** (ARVD) cannot participate. ARVD is a condition where the heart muscle of the right ventricle is replaced by fat and scar tissue, which can lead to heart rhythm problems.
Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups, so if you are outside these age ranges, you may not be eligible.
Patients who are part of a vulnerable population cannot participate. This means individuals who may be at a higher risk of harm or exploitation, such as those with certain disabilities or those who cannot give informed consent.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
CHU Gabriel-Montpied
Verified
Clermont Ferrand, France
Hospices Civils De Lyon
Responsive
Lyon, France

Trial locations

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Investigated drugs

Spironolactone is a medication used in this clinical trial to help protect the heart. It works by blocking certain hormones that can cause the heart to weaken over time. In this study, spironolactone is being tested to see if it can slow down the worsening of heart function and reduce irregular heartbeats in patients with a specific heart condition called ARVD. The researchers will use heart imaging and heart rhythm monitoring to see how well spironolactone works in these patients.

Spironolactone

What is already known about the treatment

Spironolactone – Spironolactone is taken orally in the form of tablets and is currently being studied for its effects on a heart condition called arrhythmogenic right ventricular dysplasia (ARVD). This medication is well-known in medical literature and is primarily used to help reduce the deterioration of the right side of the heart and prevent irregular heartbeats in ARVD patients. It works by blocking certain hormones in the body that can cause fluid retention and heart strain, helping to protect the heart muscle. Spironolactone is classified as a diuretic, which means it helps the body get rid of excess salt and water.

Investigated diseases

Arrhythmogenic right ventricular dysplasia – This is a heart condition where the muscle tissue in the right ventricle is replaced by fatty or fibrous tissue. This replacement disrupts the normal electrical signals in the heart, leading to arrhythmias, which are irregular heartbeats. Over time, the structural changes in the heart can cause the right ventricle to enlarge and weaken. As the disease progresses, individuals may experience symptoms such as palpitations, fainting, or shortness of breath. The condition can also affect the left ventricle, although it primarily impacts the right side of the heart. The progression of the disease can vary, with some individuals experiencing more rapid changes than others.