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NCT01815502 · ClinicalTrials.gov registry record · Phase 4
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01815502: Completed Phase 4 study, sponsored by Medical University of South Carolina.
NCT01815502 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815502, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
end-systolic elastance (often abbreviated Ees or ESPVR) is a measure of contractility (systolic function)
Interventions
- DIAGNOSTIC_TEST Cardiac catheterization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01815502 record still lists
NCT01815502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Cardiac catheterization is the first listed.
NCT01815502 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01815502 about?
NCT01815502 is a clinical study titled "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 pressu...
What is the current status of trial NCT01815502?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2013-02. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01815502?
The interventions under investigation include: Cardiac catheterization (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT01815502?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01815502's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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