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NCT04297241 · ClinicalTrials.gov registry record · Phase 2
Nitrate Effect on Exercise Capacitance
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04297241 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 20 participants.
The verdict
NCT04297241, a Phase 2 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The investigators will investigate the safety and preliminary efficacy of ISDN therapy to reduce venous congestion and improve exercise tolerance in children and adults after the Fontan operation. This will be accomplished by recruiting 15 Fontan physiology patients from the Cincinnati Children's Fontan clinic and University of Kentucky Pediatric Cardiology clinic for the investigation. The investigators will non-invasively measure both central venous pressures at rest and during graded cardiopulmonary exercise testing. In addition the study team will obtain a measurement of liver stiffness before and after a 4-week regimen of ISDN therapy. Patients will be seen twice in clinic, once before and after ISDN therapy, and phone calls will be made to ensure safety, compliance, and make appropriate alterations to medications throughout the study period. Pre- and post-intervention central venous pressure and exercise tolerance will be compared.
Interventions
- DRUG Isosorbide Dinitrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2021-05-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04297241
The ClinicalTrials.gov registry entry for NCT04297241 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Isosorbide Dinitrate is the first listed.
NCT04297241 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04297241 about?
NCT04297241 is a clinical study titled "Nitrate Effect on Exercise Capacitance". The investigators will investigate the safety and preliminary efficacy of ISDN therapy to reduce venous congestion and improve exercise tolerance in children and adults after the Fontan operation. This will be accomplished by recruiting 15 Fontan physiology patients from the Cincinnati Children's Fo...
What is the current status of trial NCT04297241?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2019-12-12. Estimated completion is 2021-05-03.
What interventions are being tested in trial NCT04297241?
The interventions under investigation include: Isosorbide Dinitrate (DRUG).
Who is sponsoring clinical trial NCT04297241?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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