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Completed

NCT Number: NCT01815502

Study of Effects of Sildenafil on Patients With Fontan Heart Circulation

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.

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Key information

Conditions

Single Ventricle Heart Disease After Fontan Surgery Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Univentricular Heart

Age range

3 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiac Catheterization

Diagnostic Test

All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization.

Primary outcomes

  1. End-systolic Elastance

    Time frame: 10 minutes after imitation of dobutamine

    end-systolic elastance (often abbreviated Ees or ESPVR) is a measure of contractility (systolic function)

Secondary outcomes

  1. End-diastolic Pressure Volume Relationship

    Time frame: 10 minutes after imitation of dobutamine

    End-diastolic pressure volume relationship (EDPVR) is a measure of diastolic (relaxation) heart function

Other outcomes

  1. Ventricular-arterial Coupling

    Time frame: 10 minutes after imitation of dobutamine

    Ventricular-arterial coupling is a measure of efficiency of ventricular work in response to the work created by the vascular tree

  2. Preload Augmentation

    Time frame: 10 minutes after imitation of dobutamine

    Preload augmentation is a measure of how quickly the heart fills with blood during exercise

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Response to Sildenafil in Patients With Fontan Physiology, A Pressure-volume Loop Analysis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2013
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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