RecruitingPHASE2INTERVENTIONAL

Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD

This study is investigating a new way to treat a rare heart condition called Arrhythmogenic Right Ventricular Dysplasia (ARVD). ARVD causes the heart's right pumping chamber to change over time, leading to irregular heartbeats. Currently, there isn't a specific treatment to stop these changes. Researchers want to see if a medicine called spironolactone, which is already used for other heart conditions, can help prevent these changes and reduce irregular heart rhythms in people with ARVD. The study will involve 120 patients in France, giving half spironolactone and half a dummy pill (placebo), and following them for three years to see if the medicine makes a difference to their heart health and quality of life.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hospices Civils de Lyon

Enrolment target

120

Start

20 Dec 2024

Estimated completion

01 Dec 2029

Arrhythmogenic Right Ventricular Dysplasia

What is this study about?

Imagine your heart is a pump. In a condition called Arrhythmogenic Right Ventricular Dysplasia (ARVD), the muscle in the right side of your heart, which pumps blood to your lungs, can start to be replaced by fatty and fibrous tissue. This can make the heart beat irregularly and less effectively over time.

Right now, treatments mainly focus on controlling these irregular heartbeats. There isn't a specific medicine that can stop these changes from happening in the heart. This study is exploring a new idea: using a medicine that's known to help prevent scarring in the heart to see if it can protect the right side of the heart in people with ARVD.

The medicine being tested is called spironolactone. It's already used for other heart conditions and is known to have anti-scarring effects. The researchers hope that by taking spironolactone, people with ARVD might experience less deterioration in their heart function and have fewer irregular heartbeats. This could lead to a better quality of life, fewer hospital visits, and a reduced risk of serious heart problems in the long run.

Key takeaways

Tests a new treatment (spironolactone) for ARVD.
Aims to slow heart changes and reduce irregular beats.
Compares spironolactone to a dummy pill (placebo).
Involves 120 patients over three years.
Participation includes regular heart tests and check-ups.
Could improve quality of life and reduce hospital visits for ARVD patients.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of ARVD based on specific medical guidelines. Your main heart pumping chamber (left ventricle) should also be working reasonably well.

There are several reasons why someone might not be able to join. For example, if you are pregnant or breastfeeding, or if you could become pregnant and don't wish to use effective birth control, you can't take part. You also can't join if you have certain existing health conditions, such as severe kidney problems, very high potassium levels in your blood, or an allergy to spironolactone. People with certain serious heart conditions not related to ARVD or who have had a heart transplant are also not eligible.

Additionally, if you are already taking certain specific heart medicines in combination (like an ACE inhibitor and a sartan), or if you are part of another study that might affect this one, you wouldn't be able to participate. The study also cannot include individuals without health insurance or those undergoing legal protection.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with ARVD by a doctor?
Are you able to use effective birth control if you are a woman who could become pregnant?
Do you *not* have severe kidney issues or very high blood potassium?
Are you *not* taking certain specific heart medications in combination?
Do you *not* have other serious conditions that might prevent you from taking spironolactone?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two groups: one receiving the study medicine (spironolactone) and the other receiving a dummy pill (placebo). Neither you nor your doctor would know which you're taking. You would visit one of 13 study centers in France, and your health would be monitored for a total of three years.

Throughout these three years, you'd have regular check-ups at 6 months, 1 year, and 3 years. These check-ups would include standard heart tests like ECGs (which check your heart's electrical activity), special ECGs for irregular beats, and 24-hour Holter monitoring (where you wear a small device to record your heart rhythm over a day). You would also have an ultrasound scan of your heart (echocardiography) and blood tests, all as part of your usual care.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment that could slow down the progression of your ARVD and reduce irregular heartbeats, which could improve your quality of life. However, as with any medication, there are potential risks and side effects associated with spironolactone. These would be fully explained by the study team. You might also receive a placebo, meaning you wouldn’t get any active study medicine, though you would still receive excellent medical care and close monitoring. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

CHU Amiens Picardie
Verified postcode
Amiens, France· Not yet recruiting
Hôpital Cardiologique Louis Pradel
Verified postcode
Bron, France· Recruiting
Hôpital Gabriel Montpied
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
CHU Dijon
Verified postcode
Dijon, France· Recruiting
Hôpital Michallon
Verified postcode
Grenoble, France· Not yet recruiting
Hôpital de la Timone
Verified postcode
Marseille, France· Not yet recruiting
Hôpital Arnaud de Villeneuve
Verified postcode
Montpellier, France· Recruiting
Hôpital Laennec
Verified postcode
Nantes, France· Recruiting
Groupe Hospitalo Universitaire Caremeau
Verified postcode
Nîmes, France· Not yet recruiting
Hôpital Pitié Salpetrière
Verified postcode
Paris, France· Recruiting
Hôpital de Haut-Lévêque
Verified postcode
Pessac, France· Not yet recruiting
Nouvel Hôpital Civil
Verified postcode
Strasbourg, France· Not yet recruiting

Common questions

What is ARVD?

ARVD is a rare heart condition where healthy heart muscle in the right pumping chamber is slowly replaced by fatty and fibrous tissue, leading to irregular heartbeats.

What is spironolactone?

Spironolactone is a medicine commonly used for heart conditions, known to help reduce scarring in the heart. This study is testing if it can help with ARVD.

Will I know if I'm getting the real medicine or a dummy pill?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're taking spironolactone or a placebo. This helps make the study results more reliable.

How long will I be in the study?

If you join, you would be followed for a total of three years, with regular check-ups at 6 months, 1 year, and 3 years.

Do I have to pay to be in the study?

No, all aspects of your participation and study-related treatments would be provided at no cost, and your health insurance is a requirement to participate.

How to find out more

Roucher Aude, PhD

aude.roucher@chu-lyon.fr 426739447 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.