Protocol Number: 06-H-0123
Patients 16 years and older with SCD and PAH may be eligible for this study. Candidates are screened with a medical history, lung function tests, blood test, echocardiogram (heart ultrasound), and measurements of exercise capacity (6-minute walk), body weight, blood pressure and heart rate. Participants undergo the following tests and procedures: Study day 1 -Physical examination, blood test, electrocardiogram (EKG), evaluation of shortness of breath, 6-minute walk test, pregnancy test for women who can become pregnant. -Heart catheterization to diagnose and evaluate PAH: A thin plastic tube is placed into a vein in the arm, neck or groin and threaded through the vessel to the heart and the blood vessels going to the lungs. This test checks blood pressure in the heart chambers and blood oxygen level in different parts of the heart and examines the valves between the chambers of the heart. Patients may be sedated for the procedure. -Medication: Patients are randomly assigned to take either 62.5 mg bosentan or a placebo in tablet form twice a day. -Weekly phone calls to check patients' health status between visits. Week 4 clinic visit -Increase bosentan to maintenance dose 125 mg. -Review health status and medication side effects. -Measure body weight, blood pressure and heart rate. -Blood test (blood test repeated at 6 weeks). Week 8 and 12 clinic visits -Evaluate shortness of breath and 6-minute walk. -Measure body weight, blood pressure and heart rate. -Review health status and medications. Week 16 clinic visit (or end of study visit if participation ends early) -Physical examination, blood test, electrocardiogram. -6-minute walk test, lung function test. -Measure body weight, blood pressure and heart rate. -Heart catheterization to measure heart function and blood flow. -Quality-of-life questionnaire. -End study medication (bosentan or placebo). 28-day follow-up clinic visit -Review medication side effects.
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