Experimental Drug Study for People with Pulmonary Arterial Hypertension
Study Summary
The University of Chicago and Dr. Gomberg are conducting a study is to assess the safety and tolerability of an experimental drug in people with Pulmonary Arterial Hypertension (PAH) who are already on existing therapy with a prostacyclin (epoprostenol/ flolan), treprostinil (remodulin), or iloprost alone or with sildenafil (viagra/revatio). This drug being used in this research study has been approved by the Food and Drug Administration for use in advanced kidney cancer. However, since it has not been approved for use in PAH its use in this study is considered experimental.
You will be asked to complete four months of study drug and have the option to continue for up to 1 year based on how well you tolerate and respond to the study drug. You will have scheduled clinic visits at the University of Chicago every week for four months and then follow up visits every three months. Some of the tests and procedures done during this study are a Right Heart Catheterization (the doctor will insert a small hollow tube, called a catheter, into a vein in your heart to measure the amount of blood pumped through the heart to the body, Echocardiogram (an ultrasound probe will take pictures of your heart), Electrocardiogram's (a graph that gives your doctor a printed readout of the electrical patterns in your heart) and Pulmonary Function tests (this will see how well your lungs are functioning).
Benefits
There may be no benefit to you for participating in this study. Information obtained during the course of this clinical research study may contribute to a better understanding of your disease and may be useful in selecting medicines for your future treatment.
Participation Details
Initial selection criteria include:
- Must be at least 18 years of age
- Must not be pregnant or breast feeding during the study
- Must be available for clinic visits for the duration of the study
- Must meet study medical criteria as evaluated by Dr. Gomberg
Study Director: Dr. Mardi Gomberg-Maitland
Department: Cardiology
For more information contact:
Sandy Coslet
(773) 834-5678
IRB: #14636A
