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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: Clinical Trial Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
At rest and then following maximal exercise, shear wave ultrasound elastography will be performed to assess if the study medication shows an improvement in liver stiffness (reduction in m/s number) following maximal exercise versus at rest.
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 |
Why NCT02769624 stopped before completion
NCT02769624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02769624 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02769624's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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