Study of Effects of Sildenafil on Patients With Fontan Heart Circulation

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 20
• Participant gender: Both

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: American Heart Association
• Treatments: Dobutamine; Sildenafil Citrate
• Last Updated: 2013-03-19

Criteria

Inclusion Criteria:

• Presence of a congenital heart defect that leads to single ventricle physiology

• Previously performed Fontan surgery

Exclusion Criteria:

• The use of 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)