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NCT01169519 · ClinicalTrials.gov registry record · Phase 1
Sildenafil in Single Ventricle Patients
A Phase 1 study of Heart Disease, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01169519: Completed Phase 1 study of Heart Disease, sponsored by Duke University.
NCT01169519 is a Phase 1 study of Heart Disease that has completed, run by Duke University. The registered enrollment target is 21 participants, below the 2,046-participant average among 31 other Heart Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01169519, a Phase 1 study of Heart Disease, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the single ventricle palliation results in continued long term attrition. Elevated pulmonary vascular resistance and impaired systemic ventricular function are important risk factors for failure of single ventricle palliation. Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in the pressure overloaded right ventricle. The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of sildenafil in single ventricle patients following stage II and III surgical palliation.
Primary Outcome
Assessment of peak sildenafil plasma concentration.
Conditions Studied
Interventions
- DRUG Sildenafil by injection
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01169519 record still lists
NCT01169519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 2,046-participant average among 31 other Heart Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Sildenafil by injection is the first listed.
NCT01169519 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01169519 about?
NCT01169519 is a clinical study titled "Sildenafil in Single Ventricle Patients". Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the single ventricle palliation...
What is the current status of trial NCT01169519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2011-04. Estimated completion is 2012-12.
What conditions does trial NCT01169519 study?
This clinical trial studies the following conditions: Heart Disease.
What interventions are being tested in trial NCT01169519?
The interventions under investigation include: Sildenafil by injection (DRUG).
Who is sponsoring clinical trial NCT01169519?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01169519 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01169519's enrollment target sits among peer trials
21 31st of 31 higher than 1 of 31 other Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Disease 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.
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