drugset / Trial / NCT01121458

Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed

NCT01121458

Phase 4 Completed 12 enrolled North Texas Veterans Healthcare System
NaSingle-groupOpen-labelDiagnostic

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).

Timeline

Start
2009-09
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Clevidipine Small molecule 0.5 mg Intravenous