Study on Sildenafil for Adults with Single Ventricle Heart Condition Post-Fontan Surgery
This clinical trial is investigating whether sildenafil can improve physical performance in adults who have undergone the Fontan operation. The Fontan procedure is a surgical intervention performed on individuals with a functionally single ventricle, where one of the heart's chambers is underdeveloped. The operation creates a special blood flow pathway that bypasses the underdeveloped right side of the heart, though this can lead to complications over time, including reduced ability to exercise and increased pressure in the veins.
Main inclusion criteria:
- Patients must have a functionally univentricular heart, meaning one of the heart's ventricles is not fully developed
- Patients must have already undergone a Fontan operation
- Patients must be at least 18 years old
- Patients should not need cardiac catheterization (a procedure where a thin tube is inserted into the heart to check its function)
- Patients must be able to provide informed consent, meaning they understand the study and agree to participate
Main exclusion criteria:
- Patients who have not had the Fontan operation
- Patients who are not in a stable clinical condition
- Patients who have an indication for cardiac catheterization
- Patients under 18 years of age
- Patients who cannot take sildenafil as part of their treatment
Focus and goal:
The primary goal of this study is to determine whether adding sildenafil to the current treatment regimen can enhance physical performance in patients with a functionally single ventricle after the Fontan operation. The study will last 24 weeks, during which participants will receive either sildenafil or a placebo. Researchers will conduct various tests to measure improvements in exercise capacity, heart function, and overall quality of life. These assessments include the ergospirometry test (which measures oxygen uptake during exercise), the 6-minute walk test (which evaluates walking distance), echocardiography (to examine heart function), and quality of life questionnaires.
Investigational drug:
The medication being studied is sildenafil, administered as 20 mg oral film-coated tablets. Sildenafil works by inhibiting an enzyme called phosphodiesterase type 5 (PDE5), which leads to relaxation of blood vessels and improved blood flow. The study aims to evaluate whether this medication can improve physical performance and exercise capacity in this patient population.
Poland