Study of Effects of Sildenafil on Patients With Fontan Heart Circulation

Completed · Phase 4 · Has a placebo group

Conditions studied: Single Ventricle Heart Disease After Fontan Surgery

In brief

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.

Key facts

Study ID

NCT01815502

Run by

Medical University of South Carolina

People needed

20

Starts

2013-02-01

Expected to finish

2014-12-01

Last updated by the study team

2018-12-07

Who can join

Age: 3 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of a congenital heart defect that leads to single ventricle physiology
• Previously performed Fontan surgery

You may not qualify if…

• 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)

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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