Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075179
Status:
TERMINATED
Last Update Posted:
2018-11-07
First Post:
2004-01-05
Brief Title:
Natrecor in Pulmonary Hypertension
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 surgeons willingness to proceed with operation
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 surgeons willingness to proceed with operation
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None