CompletedPhase 4

Study of Effects of Sildenafil on Patients With Fontan Heart Circulation

United States20 participantsStarted 2013-02

Plain-language 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.

Who can participate

Age range3 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

End-systolic Elastance

Timeframe: 10 minutes after imitation of dobutamine

Trial details

NCT IDNCT01815502

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

Results submitted2018-07-12

View on ClinicalTrials.gov More Single Ventricle Heart Disease After Fontan Surgery trials