Natrecor in Pulmonary Hypertension - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 5, 2004

Last Updated Date

March 28, 2006

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00075179 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Natrecor in Pulmonary Hypertension

Official Title ^†

Phase IV, Open Labeled Study to Test the Effectiveness of Nesiritide in Reversing Pulmonary Hypertension in Patients Who Will Be Undergoing CardioThoracic Surgery

Brief Summary

The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Pulmonary Hypertension
Cancer
Lung Disease
Cardiothoracic Surgery

Intervention ^†

Drug: Nesiritide (Natrecor)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^†

The patient population recruited for this study will include patients being considered for cardiothoracic surgery, as treatment for their cancer, who have evidence of PHTN documented by 2-dimensional and Doppler echocardiography (2D-Echo) uncovered during their pre-operative evaluation for malignancy. Eligible patients include those who have normal LV systolic function with PHTN by Doppler echocardiography, defined as a peak tricuspid velocity of 2.5m/sec or greater without evidence of significant valvular disease. An evaluation for pulmonary hypertension by 2D-Echo will have already been completed by the time the patient is considered for this study.

Inclusion Criteria:

Age 18 to 85 years old
Pulmonary Hypertension (PHTN) documented by Doppler echocardiography
Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's)
Able to sign informed consent
Patient being considered for Cardiothoracic Surgery

Exclusion Criteria:

Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90)
Active infection/sepsis
Creatinine greater than 3.0 mg/dl
LV ejection fraction < 40% (must be done with in the last 30 days prior to signing consent)
Significant valvular disease as a cause for the PHTN.
Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR > 1.6
Hypersensitivity to nesiritide or any of it's components.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00075179

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

M.D. Anderson Cancer Center

Collaborators ^††

Investigators ^†

Study Chair:

Daniel J. Lenihan, MD

M.D. Anderson Cancer Center

Information Provided By

M.D. Anderson Cancer Center

Verification Date

March 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.