Natrecor in Pulmonary Hypertension - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00075179

Purpose

The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs.

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.

Condition	Intervention	Phase
Pulmonary Hypertension Cancer Lung Disease Cardiothoracic Surgery	Drug: Nesiritide (Natrecor) Procedure: Right Heart Catheterization	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer High Blood Pressure Pulmonary Hypertension Surgery

Drug Information available for: Nesiritide

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number Patients with 20% reduction in mean pulmonary arterial (PA) pressure to measure pulmonary hypertension (PHTN) [ Time Frame: Baseline and 15 and 30 mintues after end of procedure ] [ Designated as safety issue: No ]

Enrollment:	7
Study Start Date:	January 2004
Study Completion Date:	March 2006
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nesiritide: Experimental Nesiritide 0.01 mcg/kg/min by vein over 30 minutes during right heart catheterization procedure.	Drug: Nesiritide (Natrecor) Given initially as a bolus (2 mcg/kg) and than infused for 30 minutes (0.01 mcg/kg/min) during right heart catheterization. Procedure: Right Heart Catheterization Small tubes placed in neck vein to heart as means of measuring pressure in heart and lungs; treatment with nesiritide delivered during procedure.

Detailed Description:

Patients with high pressure in their lungs often have many symptoms such as, shortness of breath, low energy, and fatigue. Decreasing the pressure in the lungs may help these patients feel better. The drug nesiritide was designed to help treat heart failure, however, it may also help to decrease the pressure in the lungs.

Before treatment, you will be asked questions about your medical history and about any medications you are currently taking. You will have a focused physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will have an ultrasound on your heart called an echocardiogram to measure the pressures in your lungs and your ability to breathe will be evaluated. With the aid of the research nurse, you will have a 6-minute walk test if you are able. You may stop or sit down at any time during the test. This test is being done to evaluate your energy level. You will also be asked to complete a questionnaire about your symptoms. This questionnaire will take no longer than 10 minutes to complete.

In order to measure the pressure in your lungs, you will have a procedure called a "right heart catheterization". This is a procedure that may have been done as part of your standard of care if you were not enrolled in this study. For this procedure, a small tube will be placed in a vein in your neck. A longer tube will be inserted into the first tube and fed through the vein and into your heart. This tube will be used to measure the pressure in your heart and lungs. If the pressure in your lungs is above a certain level, you will receive treatment with nesiritide during the right heart catheterization procedure. Nesiritide will be given by vein over 30 minutes. After treatment, the pressure in your heart and lungs will be measured again. You will be awake during this procedure and lying flat on your back. An anesthetic will be used to numb the area of your neck where the tube is placed. The entire procedure (including treatment) should take no longer than 2 hours. When complete, the tubes will be removed.

Within 15 minutes of the end of the procedure, the 6-minute walk test (if you are able) and the questionnaire about your symptoms will be repeated and your breathing will be reassessed.

You will also have around 2 teaspoons of blood collected for special lab tests. These tests are being done to check for certain molecules in your blood. The blood that is leftover after these tests may be stored in a freezer.

Around 30 days after the procedure, you will have a follow-up visit scheduled or contacted by phone. At this visit, you will have a complete physical exam done by the doctor, and possibly have blood work done if required by the doctor as part of your routine care. There will be no additional blood work done for study purposes.

This is an investigational study. Nesiritide is FDA approved and is commercially available only for the treatment of heart failure. However, the use of nesiritide in this study is experimental. Around 20 patients will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 18 to 85 years old.
Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's).
PHTN documented by Doppler Echocardiography ( Done with in last 30 days)
Must be able to give an informed consent.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075179

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Study Chair:

Daniel J. Lenihan, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Drug information This link exits the ClinicalTrials.gov site

MD Anderson Cancer Center, Department of Cardiology This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Daniel J. Lenihan, MD / Professor )
Study ID Numbers:	2003-0562
Study First Received:	January 5, 2004
Last Updated:	October 23, 2009
ClinicalTrials.gov Identifier:	NCT00075179 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Pulmonary hypertension
cancer
lung cancer
lung disease
cardiothoracic surgery

Nesiritide
Natrecor
CV Surgery
Lung Tumor

Additional relevant MeSH terms:

Natriuretic Peptide, Brain
Respiratory Tract Diseases
Natriuretic Agents
Hypertension, Pulmonary
Therapeutic Uses
Lung Diseases

Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009