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NCT01121458 · ClinicalTrials.gov registry record · Phase 4
Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed
A Phase 4 study, sponsored by North Texas Veterans Healthcare System.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT01121458 is a Phase 4 study that has completed, run by North Texas Veterans Healthcare System. The registered enrollment target is 12 participants.
The verdict
NCT01121458, a Phase 4 study, has completed, sponsored by North Texas Veterans Healthcare System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
Pulmonary arterial hypertension (PAH) is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (PA) rises above normal levels and may become life threatening. PAH is frequently misdiagnosed and has often progressed to late stage by the time it is accurately diagnosed. PAH has been historically chronic and incurable with a poor survival rate. However, new treatments are available which have significantly improved prognosis. Right-heart catheterization (RHC) is the most accurate and useful test for PAH, and the only test that directly measures the pressure inside the PA. It is performed in all patients at least once, to get a definitive diagnosis of PAH. The most commonly used medication for this purpose is intravenous nitroprusside, however this medication in about 25-30% of patients is not well tolerated as it cause fast heart rates, which is not well tolerated by patients with pulmonary hypertension and/or heart failure. The CARVE study assesses the effect of Clevidipine, an ultra-short acting vasoselective calcium antagonist, on pulmonary vascular resistance (PVR) and its utility for pulmonary vasoreactivity testing during right heart catheterization (RHC) of patients with pulmonary hypertension (PAH).
Interventions
- DRUG Clevidipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01121458
The ClinicalTrials.gov registry entry for NCT01121458 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is North Texas Veterans Healthcare System, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Clevidipine is the first listed.
NCT01121458 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01121458 about?
NCT01121458 is a clinical study titled "Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed". Pulmonary arterial hypertension (PAH) is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (PA) rises above normal levels and may become life threatening. PAH is frequently misdiagnosed and has often progressed to late stage by the time it is accurately diagnosed...
What is the current status of trial NCT01121458?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2009-09. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01121458?
The interventions under investigation include: Clevidipine (DRUG).
Who is sponsoring clinical trial NCT01121458?
This trial is sponsored by North Texas Veterans Healthcare System, which has 23 total clinical trials registered on ClinicalTrials.gov.
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