RecruitingRare disease

Study on Valsartan and Sacubitril for Preventing Disease Progression in Patients with Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Verified siteRegistered drugNo placebo

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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 Cardiomyopathy (ARVC). This condition affects the heart muscle, leading to irregular heartbeats and potentially heart failure. The study will use a medication called Entresto, which is a combination of two active substances: valsartan and sacubitril. These substances work together as an Angiotensin II receptor antagonist and a neprilysin inhibitor, which may help in managing heart conditions by reducing strain on the heart.

The purpose of this study is to explore how Entresto can help prevent the progression of ARVC by examining its effects on heart muscle changes and heart function. Participants in the study will be randomly assigned to receive either the medication or a placebo. The study will last for a period of up to 48 weeks, during which participants will take the medication orally in the form of film-coated tablets. Throughout the study, various tests such as Cardiac Magnetic Resonance (CMR) and Electrocardiogram (ECG) will be conducted to monitor heart health and function.

By participating in this study, researchers aim to gather valuable information on how Entresto can potentially benefit individuals with ARVC. The study will focus on assessing changes in heart muscle structure, heart function, and the occurrence of irregular heartbeats. This research could contribute to better understanding and management of ARVC, potentially leading to improved treatment options for those affected by this heart condition.

The research process

The trial runs in 5 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, a diagnosis of arrhythmogenic right ventricular cardiomyopathy (ARVC) is confirmed based on specific criteria.
Eligibility includes being over 18 years old and having a left ventricular ejection fraction of at least 40%.
Step 2
Medication administration
The medication Entresto, which contains sacubitril and valsartan, is administered orally in the form of film-coated tablets.
Dosages available are 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, depending on the specific requirements of the study.
Step 3
Monitoring and assessments
Regular assessments are conducted to monitor the degree of fibrosis in the heart muscle and the function of the left ventricle using imaging techniques.
Additional tests include measuring NT-proBNP levels and other markers, as well as evaluating heart rhythm and physical capacity.
Step 4
Follow-up and evaluation
Throughout the study, follow-up visits are scheduled to evaluate the progression of the condition and the effects of the medication.
The study aims to assess the anti-fibrotic and remodeling effects of the medication over time.
Step 5
Completion of the study
The study is expected to conclude by April 2029, with final evaluations conducted to determine the overall impact of the treatment on disease progression.

Who can join the trial?

4 criteria

Have a confirmed diagnosis of ARVC, which is a heart condition, based on specific criteria from 2010.
Be older than 18 years.
Agree to participate by signing a written consent form.
Have a Left Ventricular Ejection Fraction (LVEF) of 40% or higher. This is a measure of how well the heart is pumping blood, checked by a special heart scan called CMR.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to the study medication.
Patients with severe kidney problems that require dialysis.
Patients with severe liver disease.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of drug or alcohol abuse within the past year.
Patients with uncontrolled high blood pressure.
Patients with a history of certain heart conditions, such as a recent heart attack.
Patients who are unable to follow the study procedures or take the study medication as directed.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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

Responsive
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, Poland
Responsive
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, Poland
Responsive
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland

Trial locations

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Investigated drugs

Sacubitril/valsartan is a medication used in this trial to evaluate its potential benefits in preventing the progression of a specific heart condition. It is being studied for its ability to reduce fibrosis and remodeling of the heart tissue, which are common issues in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC). This medication combines two active ingredients that work together to help manage heart failure and improve heart function.

What is already known about the treatment

Sacubitril/Valsartan – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating arrhythmogenic right ventricular cardiomyopathy (ARVC). The main therapeutic indication is to prevent disease progression in patients with this condition. Sacubitril/valsartan works by inhibiting the enzyme neprilysin and blocking angiotensin II receptors, which helps reduce fibrosis and remodeling of the heart tissue. It is classified as an angiotensin receptor-neprilysin inhibitor (ARNI).

Investigated diseases

Arrhythmogenic Right Ventricular Cardiomyopathy – This is a rare heart condition where the muscle tissue in the right ventricle is replaced by fatty or fibrous tissue. This process can disrupt the normal electrical signals in the heart, leading to irregular heartbeats or arrhythmias. Over time, the structural changes in the heart muscle can affect its ability to pump blood effectively. The disease often progresses slowly, but the changes in the heart's structure and function can lead to symptoms such as palpitations, dizziness, or fainting. It is often diagnosed in young adults and athletes, as physical activity can exacerbate symptoms. The condition is genetic, meaning it can run in families, and it requires careful monitoring to manage its progression.