Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed

NCT01121458 | Completed Phase 4

• 1 other identifier: Dallas VA #09-041
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Hypertension, Pulmonary

Keywords

pulmonary artery; vascular resistance

Outcome Measures

Primary Outcomes (1)

• Percent reduction in PVR with clevidipine in (1) nitroprusside responders and (2) patients with indeterminate nitroprusside reactivity tests

  During right heart catheterization (1-2 hours)

Secondary Outcomes (1)

• Efficacy/ safety measured by % reduction in PVR with clevidipine in patients with indeterminate reactivity tests & total study population;%patients with successful 20% reduction in PVR; SAE & adverse hemodynamic response to clevidipine during procedure

  During right heart catheterization (1-2 hrs)

Interventions

Clevidipine DRUG

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.

Also known as: Cleviprex

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent before initiation of any study related procedures.
• years of age or older
• Referred for clinically indicated pulmonary vascular resistance assessment
• Presence of pulmonary hypertension by non-invasive testing
• Patients referred for RHC and vasoreactivity testing

You may not qualify if:

• Patient with baseline SBP \< 100 mmHg
• Patient with HR\>120 beats/minute
• Patients with severe or valvular heart disease
• Patients with an acute coronary syndrome
• Patients with a creatinine clearance \< 30 ml/min
• Patients with class IV congestive heart failure
• Patients with platelet count \< 100,000 per cc3
• Patients with hemoglobin \< 10g/dl
• Patient with INR \> 1.5
• Patients with positive pregnancy test - women between 21 and 60 years of age
• Patients with known or suspected allergy to study drug or study drug components, including allergy to soybeans, soy products, eggs, or egg products
• Patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia
• Patients with contraindications to the use of IV nitroprusside
• Patients with diagnosed or suspected intra-cardiac or systemic arteriovenous shunts
• Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 3 months of randomization.

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (1)

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Subhash Banerjee, MD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief- Division of Cardiology

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: May 12, 2010
• Study Start: September 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 10, 2013

Record last verified: 2013-06

Locations

US (1)