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NCT03122639 · ClinicalTrials.gov registry record · Early Phase 1
Endothelial Function in Obstructive Sleep Apnea
A Early Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 106
- Enrollment target
NCT03122639 is a Early Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 106 participants.
The verdict
NCT03122639, a Early Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 106 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA), a condition that affects a quarter of the Western adults, triples the risk for cardiovascular diseases and increases all-cause mortality. Intermittent hypoxia (IH) during transient cessation of breathing in OSA leads to endothelial inflammation, a key step in the initiation and progression of cardiovascular disease. However, the mechanisms that mediate IH-induced endothelial inflammation remain unclear and, consequently, no targeted therapy is available for vascular manifestations of OSA. Using endothelial cells (ECs) freshly harvested from OSA patients, they study team has identified impaired complement inhibition as an initial stimulus for endothelial inflammation in IH, thereby linking for the first time complement activation to vascular risk in OSA. The investigators found that a major complement inhibitor cluster of differentiation (CD59), a plasma membrane protein that inhibits the formation of the terminal complement membrane attack complex (MAC) and protects host cells from complement injury, is internalized from the EC surface in OSA patients. Consequent MAC deposition initiates endothelial inflammation in IH. Importantly, the investigators showed that IH does not significantly affect inflammation in ECs in the absence of complement, suggesting that complement activation has an essential role in endothelial inflammation in OSA. Interestingly, internalization of CD59 in IH appears to be cholesterol-dependent and statins prevent MAC deposition on ECs in IH in a CD59-dependent manner, suggesting a novel therapeutic strategy to reduce vascular risk in OSA. This led the study team to hypothesize that IH-induced cellular cholesterol accumulation reduces complement inhibition via increased internalization of CD59 from the EC surface leading to increased MAC deposition, and that treatment of OSA with continuous positive airway pressure (CPAP) and/or statins reverses endothelial dysfunction by restoring complement inhibition.
Interventions
- DRUG Placebo
- DRUG Atorvastatin 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2017-09-01 |
| Est. Completion | 2021-05-07 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03122639
The ClinicalTrials.gov registry entry for NCT03122639 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03122639 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03122639 about?
NCT03122639 is a clinical study titled "Endothelial Function in Obstructive Sleep Apnea". Obstructive sleep apnea (OSA), a condition that affects a quarter of the Western adults, triples the risk for cardiovascular diseases and increases all-cause mortality. Intermittent hypoxia (IH) during transient cessation of breathing in OSA leads to endothelial inflammation, a key step in the initi...
What is the current status of trial NCT03122639?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 106 participants. The study started on 2017-09-01. Estimated completion is 2021-05-07.
What interventions are being tested in trial NCT03122639?
The interventions under investigation include: Placebo (DRUG), Atorvastatin 10mg (DRUG).
Who is sponsoring clinical trial NCT03122639?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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