Imatinib and Carvedilol for High Blood Pressure in the Lungs in Adults With Sickle Cell Disease
Status:
Withdrawn
Trial end date:
2012-12-11
Target enrollment:
Participant gender:
Summary
Background:
- About one-tenth of adults with sickle cell disease have pulmonary hypertension (high blood
pressure in the lungs). This condition can cause shortness of breath, pain crisis, and
congestive heart failure. It may even lead to death. Researchers want to test the drugs
imatinib and carvedilol to see if they can treat high blood pressure in the lungs. Both drugs
have been used to treat other types of heart problems, but they have not been tested as a
treatment for high blood pressure related to sickle cell disease.
Objectives:
- To see if imatinib and carvedilol are safe and effective treatments for high blood pressure
in the lungs in adults with sickle cell disease.
Eligibility:
- Adults at least 18 years of age who have sickle cell disease and have or may have high
blood pressure in the lungs.
Design:
- Participants will be screened with a physical exam and medical history. They will also
have different tests of heart and lung function, including a walking test and imaging
studies. Blood and urine samples will also be collected.
- Participants who meet specific criteria will take one of two possible study drugs. Those
who receive imatinib will take it daily. Those who receive carvedilol will take it twice
a day.
- Participants will have weekly study visits for blood tests and other exams. The study
drug dose will be adjusted at each weekly visit. It will be increased slowly to reach a
target dose(based on the participant s weight) or to find a stable effective dose.
- Participants may continue to take their study drug for up to 24 weeks, with weekly study
visits. Regular blood samples and heart and lung function tests will be performed.
- After 24 weeks, qualified participants may continue to take their study drug for up to 6
more months. They will have regular study visits to monitor the treatment.