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

Primary Purpose

Hypertension, Pulmonary

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Clevidipine

About this trial

This is an interventional diagnostic trial for Hypertension, Pulmonary focused on measuring pulmonary artery, vascular resistance

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

VA North Texas Health Care System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01121458

First Posted

February 2, 2010

Last Updated

June 7, 2013

Sponsor

North Texas Veterans Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT01121458

Brief Title

Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed

Acronym

CARVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

North Texas Veterans Healthcare System

4. Oversight

Data Monitoring Committee

5. Study Description

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: Performance of clinically indicated RHC with assessment of pulmonary hypertension and pulmonary vascular resistance (PVR). Performance of clinically indicated pulmonary vasoreactivity assessment with IV Nitroprusside (standard of care) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Pulmonary

Keywords

pulmonary artery, vascular resistance

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Clevidipine

Other Intervention Name(s)

Cleviprex

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

Time Frame

During right heart catheterization (1-2 hrs)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Subhash Banerjee, MD

Organizational Affiliation

North Texas Veterans Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA North Texas Health Care System

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

12. IPD Sharing Statement

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Clevidipine for Vasoreactivity Evaluation of the Pulmonary Arterial Bed

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