NCT01121458

Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed

Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed (CARVE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: North Texas Veterans Healthcare System · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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).

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 inclusion/exclusion 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.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	Clevidipine	The clevidipine infusion is to be administered via IV infusion at a starting dose of 0.5 mg/hour. The dose may be doubled every three (3) minutes to a maximum dose of 32 mg/hr as tolerated, until a 20% reduction in PVR is achieved or until the patient experiences hypotension (SBP\< 80 mmHg), hypertension (SBP\>150 mmHg), tachycardia (120 beats per minute), bradycardia (\<50 beats per minute), or symptoms of hypotension or ischemia (chest pain, anxiety, nausea, vomiting), allergic reaction (hives, urticaria) or other adverse event. Clevidipine infusion may be terminated at any time for a safety reason or at the investigator's discretion.

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-05-12
• Last updated: 2013-06-10

Locations

1 site across 1 country: United States