Phase 4
N=20
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
Single Ventricle Heart Disease After Fontan Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01815502 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: End-systolic Elastance — 0.85; 1.8 Ees in mmHg/ml/m2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cardiac catheterization (Diagnostic_test)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY End-systolic Elastance |
0.85; 1.8 | — |
| SECONDARY End-diastolic Pressure Volume Relationship |
499; 953 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01815502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.