Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 3 - 40 |
| Updated: | 12/9/2018 |
| Start Date: | February 2013 |
| End Date: | December 2014 |
Response to Sildenafil in Patients With Fontan Physiology, A Pressure-volume Loop Analysis
The study will investigate the cardiovascular effects of sildenafil on patients with Fontan
circulation. Recent studies suggest that sildenafil may improve exercise in patients with
Fontan circulation. However, why this occurs is not known. The study will used specialized
catheters to measure pressure and volume. The measure of pressure and volume leads to more
detailed analysis of heart function. Patients will receive either sugar pill or sildenafil
prior to catheterization. It is believed that sildenafil will improve relaxation and
contraction of the heart.
circulation. Recent studies suggest that sildenafil may improve exercise in patients with
Fontan circulation. However, why this occurs is not known. The study will used specialized
catheters to measure pressure and volume. The measure of pressure and volume leads to more
detailed analysis of heart function. Patients will receive either sugar pill or sildenafil
prior to catheterization. It is believed that sildenafil will improve relaxation and
contraction of the heart.
Modifications to surgical procedures and medical treatment have led to a rapidly declining
mortality rates in patients with single-ventricle heart disease (SV). However, SV patients
still suffer from lower quality of life, decreased exercise capacity, worse
neurodevelopmental outcomes and many other morbidities. While patients with SV circulation
only make a small portion of all congenital heart diseases, 2-4 %, they require a great deal
of resource utilization.
Standard medical treatments for adult heart failure have not had the same success in the SV
population. Phosphodiesterase 5 (PDE5) inhibitors have recently become a frequently used
medication class in patients with SV heart disease to treat pulmonary hypertension, heart
failure, as well as "Fontan" failure (i.e., plastic bronchitis and protein-losing
enteropathy). While there have been findings of improved measures of exercise capacity and
some reports of improved symptoms of heart failure, the physiologic mechanisms behind these
findings are not completely understood. There have been reports, indicating that the
phosphodiesterase five inhibitors improve ventricular function in biventricular circulation
patients and animal models. The aim of our study was to investigate the effect of acute PDE5
inhibition on ventricular function in SV patients after the final palliative surgery, the
Fontan procedure.
mortality rates in patients with single-ventricle heart disease (SV). However, SV patients
still suffer from lower quality of life, decreased exercise capacity, worse
neurodevelopmental outcomes and many other morbidities. While patients with SV circulation
only make a small portion of all congenital heart diseases, 2-4 %, they require a great deal
of resource utilization.
Standard medical treatments for adult heart failure have not had the same success in the SV
population. Phosphodiesterase 5 (PDE5) inhibitors have recently become a frequently used
medication class in patients with SV heart disease to treat pulmonary hypertension, heart
failure, as well as "Fontan" failure (i.e., plastic bronchitis and protein-losing
enteropathy). While there have been findings of improved measures of exercise capacity and
some reports of improved symptoms of heart failure, the physiologic mechanisms behind these
findings are not completely understood. There have been reports, indicating that the
phosphodiesterase five inhibitors improve ventricular function in biventricular circulation
patients and animal models. The aim of our study was to investigate the effect of acute PDE5
inhibition on ventricular function in SV patients after the final palliative surgery, the
Fontan procedure.
Inclusion Criteria:
- Presence of a congenital heart defect that leads to single ventricle physiology
- Previously performed Fontan surgery
Exclusion Criteria:
- The use of phosphodiesterase type 5 (PDE5) inhibitors at the time of catheterization
of within 1 month of catheterization
- Unstable arrhythmia at the time of catheterization
- History of unstable arrhythmia within 2 months of catheterization
- Venous, arterial or cardiac malformation that precludes the proper placement of a
microconductance catheter
- Allergy to sildenafil or previous significant adverse reaction to sildenafil
(e.g. hypotension)
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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