Study on Sildenafil for Adults with Single Ventricle Heart Condition Post-Fontan Surgery

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What is this study about?

This clinical trial is focused on studying the effects of the medication sildenafil in adults who have undergone a specific heart surgery known as the Fontan operation. This surgery is typically performed on individuals with a congenital heart defect called a functionally single ventricle, where one of the heart’s ventricles is underdeveloped. The Fontan operation helps improve blood flow in these patients by creating a pathway that bypasses the right side of the heart, which can lead to complications over time, including reduced exercise capacity and increased pressure in the veins.

The purpose of this study is to determine if adding sildenafil to the current treatment regimen of these patients can enhance their physical performance. Sildenafil is a medication that is often used to treat conditions related to blood flow. In this study, participants will receive either sildenafil or a placebo for a period of 24 weeks. Throughout the study, various tests will be conducted to assess improvements in exercise capacity, heart function, and overall quality of life.

Participants will undergo tests such as the ergospirometry test, which measures oxygen uptake during exercise, and the 6-minute walk test, which evaluates the distance they can walk in six minutes. Other assessments will include echocardiography to examine heart function and questionnaires to gauge quality of life. The study aims to provide insights into whether sildenafil can be a beneficial addition to the treatment of patients with a functionally single ventricle after the Fontan operation.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. These include having a functionally univentricular heart, being in a post-Fontan operation condition, and being over 18 years old. Informed consent is required.

2 initial assessment

An initial assessment is conducted to establish baseline health metrics. This includes measuring physical performance and exercise capacity.

3 medication administration

The study involves the administration of sildenafil, a medication used to improve physical performance. The dosage is 20 mg, taken orally in the form of film-coated tablets. The medication is administered regularly over a period of 24 weeks.

4 ongoing monitoring

Throughout the 24-week period, regular monitoring is conducted to assess the effects of the medication. This includes tests to measure peak oxygen uptake, exercise capacity, and other health indicators.

5 final assessment

At the end of the 24-week treatment period, a final assessment is conducted. This includes measuring changes in physical performance, exercise capacity, and quality of life.

Who Can Join the Study?

Have a functionally univentricular heart. This means having a heart condition where one of the heart’s ventricles is not fully developed.
Have had a Fontan operation, which is a type of heart surgery that helps improve blood flow in people with a single ventricle.
No need for cardiac catheterization, a procedure where a thin tube is inserted into the heart to check its function.
Be over 18 years old.
Agree to participate in the study by providing informed consent, which means understanding the study and agreeing to take part.

Who Cannot Join the Study?

Patients who have not undergone the Fontan operation cannot participate.
Patients who are not in a stable clinical condition are excluded.
Patients who have an indication for cardiac catheterization are not eligible.
Patients who are not adults are excluded from the study.
Patients who are not able to take sildenafil as part of their therapy cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Sildenafil

Sildenafil is a medication being studied for its potential to improve physical performance in adult patients with a univentricular heart who have undergone a Fontan operation. The study aims to see if adding sildenafil to the patients’ current treatment can enhance their ability to perform physical activities.

Investigated diseases:

Functionally Single Ventricle – This condition involves congenital heart defects where one of the heart’s ventricles is underdeveloped or a valve is missing or too small, making it impossible to correct the heart defect completely. Patients often undergo the Fontan operation, a procedure that reroutes blood flow to improve oxygen levels and reduce strain on the heart. This operation creates a unique circulation system by bypassing the right heart chambers, which can lead to increased venous pressure and decreased cardiac output. Over time, patients may experience increased pulmonary resistance, which can further reduce heart efficiency and exercise tolerance. Despite the benefits of the Fontan operation, patients may face complications and reduced exercise capacity as they age. These challenges can significantly impact their quality of life and physical performance.

Trial ID:

2023-503913-31-01

Protocol code:

2.16/VI/22

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Sildenafil for Adults with Single Ventricle Heart Condition Post-Fontan Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?