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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121458
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : June 10, 2013
Information provided by (Responsible Party):
Subhash Banerjee, North Texas Veterans Healthcare System

Tracking Information
First Submitted Date  ICMJE February 2, 2010
First Posted Date  ICMJE May 12, 2010
Last Update Posted Date June 10, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
Percent reduction in PVR with clevidipine in (1) nitroprusside responders and (2) patients with indeterminate nitroprusside reactivity tests [ Time Frame: During right heart catheterization (1-2 hours) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
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 [ Time Frame: During right heart catheterization (1-2 hrs) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed
Official Title  ICMJE Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed (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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hypertension, Pulmonary
Intervention  ICMJE 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.
Other Name: Cleviprex
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2010)
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provide written informed consent before initiation of any study related procedures.
  • 21 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

Exclusion Criteria:

  • 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.
  • Other medical conditions that, in the opinion of the investigator, preclude participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01121458
Other Study ID Numbers  ICMJE Dallas VA #09-041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Subhash Banerjee, North Texas Veterans Healthcare System
Original Responsible Party Subhash Banerjee,MD, VA North Texas Health Care System
Current Study Sponsor  ICMJE North Texas Veterans Healthcare System
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Subhash Banerjee, MD North Texas Veterans Healthcare System
PRS Account North Texas Veterans Healthcare System
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP