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NCT02769624 · ClinicalTrials.gov registry record · Phase 2
Acute Effects of Inhaled Treprostinil in Fontan Patients
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT02769624 is a Phase 2 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 15 participants.
The verdict
NCT02769624, a Phase 2 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
In this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular function in stable Fontan patients. Investigators will also assess the effects of resting and acute rises in exercise induced systemic venous pressure on liver stiffness and will also assess whether treprostinil will attenuate the acute stiffness increase that investigators expect to see. This will be a prospective, randomized, double-blinded placebo controlled, crossover trial. Following recruitment and informed consent, each participant will undergo three study visits, including baseline testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.
Interventions
- DRUG Placebo
- DRUG Treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2018-09-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02769624
The ClinicalTrials.gov registry entry for NCT02769624 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 15 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 2 interventions - of which Placebo is the first listed.
NCT02769624 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02769624 about?
NCT02769624 is a clinical study titled "Acute Effects of Inhaled Treprostinil in Fontan Patients". In this pilot study investigators propose to explore the effects of a locally delivered inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood flow, venous pressure response and vascular function in stable Fontan patients. Investigators will also assess the eff...
What is the current status of trial NCT02769624?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2017-02-21. Estimated completion is 2018-09-21.
What interventions are being tested in trial NCT02769624?
The interventions under investigation include: Placebo (DRUG), Treprostinil (DRUG).
Who is sponsoring clinical trial NCT02769624?
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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