Phase IV, Open Labeled Study to Test the Effectiveness of Nesiritide in Reversing Pulmonary Hypertension in Patients Who Will be Undergoing CardioThoracic Surgery
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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number Patients with 20% reduction in mean pulmonary arterial (PA) pressure to measure pulmonary hypertension (PHTN)
Baseline and 15 and 30 mintues after end of procedure
Daniel J. Lenihan, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|