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NCT03945643 · ClinicalTrials.gov registry record · Early Phase 1
Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?
A Early Phase 1 study of Patent Foramen Ovale and Intrapulmonary Arteriovenous Anastamosis, sponsored by University of Oregon.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 82
- Enrollment target
- 1
- Study location
NCT03945643: Completed Early Phase 1 study of Patent Foramen Ovale and Intrapulmonary Arteriovenous Anastamosis, sponsored by University of Oregon.
NCT03945643 is a Early Phase 1 study of Patent Foramen Ovale and Intrapulmonary Arteriovenous Anastamosis that has completed, run by University of Oregon. The registered enrollment target is 82 participants, below the 410-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03945643, a Early Phase 1 study of Patent Foramen Ovale and Intrapulmonary Arteriovenous Anastamosis, has completed, sponsored by University of Oregon.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 82 participants
- Enrollment target
- 1
- Study location
Study Summary
In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. The investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to investigate the relationships between PFO and IPAVA blood flow. The investigators will use a placebo-controlled intervention (sildenafil) to reduce pulmonary arterial pressure in these subjects to examine the impact of the change in pressure (or absence of change) on the relationships determined above.
Primary Outcome
Pulmonary arterial pressure measured by ultrasound techniques
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Sildenafil
Study Locations (1)
Oregon
- Cardiorespiratory and Pulmonary Physiology Lab - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2023-07-31 |
| Phase | Early Phase 1 |
What the finished NCT03945643 record still lists
NCT03945643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 410-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Patent Foramen Ovale appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03945643 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT03945643 about?
NCT03945643 is a clinical study titled "Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?". In summary, the investigators propose to study elite Croatian breath-hold and SCUBA divers. The investigators will quantify breath-hold hypoxia- and SCUBA diving-induced pulmonary hypertension and right heart function to investigate the relationships between PFO and IPAVA blood flow. The investigato...
What is the current status of trial NCT03945643?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 82 participants. The study started on 2019-07-01. Estimated completion is 2023-07-31.
What conditions does trial NCT03945643 study?
This clinical trial studies the following conditions: Patent Foramen Ovale, Intrapulmonary Arteriovenous Anastamosis.
What interventions are being tested in trial NCT03945643?
The interventions under investigation include: Placebo (OTHER), Sildenafil (DRUG).
Who is sponsoring clinical trial NCT03945643?
This trial is sponsored by University of Oregon, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03945643 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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