Hypertension, Pulmonary Clinical Trial
Official title:
Pilot of Oral Sildenafil for the Treatment of Pulmonary Hypertension in Thalassemia With Comparison to Controls
Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Many people with thalassemia also have pulmonary hypertension, which is high blood pressure in the arteries in the lungs. This study will evaluate the safety and effectiveness of the medication sildenafil at reducing blood pressure in the lungs of people with thalassemia and pulmonary hypertension.
Thalassemia is an inherited blood disorder in which the body makes an abnormal form of
hemoglobin—the protein in red blood cells that carries oxygen. A potential complication of
thalassemia is pulmonary hypertension, which is a condition characterized by abnormally high
blood pressure in the arteries of the lungs. People with thalassemia who have pulmonary
hypertension tend to experience more health complications, including shortness of breath and
a reduced exercise capacity, than people with thalassemia who do not have pulmonary
hypertension. Sildenafil is a medication that is used to treat pulmonary hypertension;
however, it has not yet been studied in people with thalassemia. The purpose of this study
is to evaluate the safety and effectiveness of sildenafil at reducing blood pressure in the
lungs of people who have thalassemia and pulmonary hypertension. Study researchers will also
further compare the differences between people with thalassemia who have pulmonary
hypertension and those who do not have pulmonary hypertension.
This study will enroll people with thalassemia who have pulmonary hypertension and a control
group of people with thalassemia who do not have pulmonary hypertension. People with
thalassemia and pulmonary hypertension will attend a baseline study visit at which time they
will undergo the following procedures: medical history and medical record review; physical
exam; a 6-minute walk test, which will measure how far participants can walk in 6 minutes;
an echocardiogram to obtain images of the heart; blood collection; and for females, a urine
collection. Participants will then begin taking sildenafil three times a day for 12 weeks.
At study visits at Weeks 2, 4, and 8, participants will undergo repeat baseline testing, and
some participants will take part in an exhaled nitric oxide test. At Week 12, participants
will also undergo lung function testing and a chest magnetic resonance imaging (MRI)
procedure.
Participants in the control group will attend one to three study visits at baseline, which
will include the same baseline study procedures listed above, plus lung function testing, a
chest MRI, a chest computed tomography (CAT) scan, and exhaled nitric oxide testing. They
will not receive any medication or have any further study visits.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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