Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01121458
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2010-02-02
Brief Title:
Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed
Sponsor:
North Texas Veterans Healthcare System
Organization:
North Texas Veterans Healthcare System
Study Overview
Official Title:
Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed CARVE
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARVE
Brief 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 andor 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
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 andor 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
Detailed Description:
CARVE is a Phase 4 open-label descriptive observational trial in PAH patients undergoing invasive vasoreactivity testing in the cath lab at the Dallas VA Medical Center Patients clinically indicated for RHC and assessment of pulmonary artery vasoreactivity will be enrolled if they meet the inclusionexclusion criteria The study will involve the following tests
1 Performance of clinically indicated RHC with assessment of pulmonary hypertension and pulmonary vascular resistance PVR
2 Performance of clinically indicated pulmonary vasoreactivity assessment with IV Nitroprusside standard of care
3 For patients who are responsive to Nitroprusside or those who have an inconclusive result because of intolerability to Nitroprusside pulmonary vasoreactivity assessment with study drug IV will be conducted
1 Performance of clinically indicated RHC with assessment of pulmonary hypertension and pulmonary vascular resistance PVR
2 Performance of clinically indicated pulmonary vasoreactivity assessment with IV Nitroprusside standard of care
3 For patients who are responsive to Nitroprusside or those who have an inconclusive result because of intolerability to Nitroprusside pulmonary vasoreactivity assessment with study drug IV will be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None