CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Cardiac catheterizationother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01815502
NCT01815502Phase 4Completed
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Response to Sildenafil in Patients With Fontan Physiology, A Pressure-volume Loop Analysis

Medical University of South Carolina·interventional·Posted Mar 21, 2013·Updated Dec 7, 2018

In Brief

A Phase 4 clinical trial evaluating Cardiac catheterization for Single Ventricle Heart Disease After Fontan Surgery. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSingle Ventricle Heart Disease After Fontan Surgery
CountriesUnited States
CollaboratorsAmerican Heart Association

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 21, 2013
Enrollment StartFeb 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.3 years ago

Interventions

Cardiac catheterizationother

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.