Hypertension, Pulmonary Clinical Trial
Official title:
Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. Currently, no medications can reverse the damage to the lungs caused by IPF, but individuals are encouraged to engage in moderate exercise to strengthen lung function. This study will evaluate the effectiveness of sildenafil at improving exercise tolerance and breathing difficulties in individuals with IPF.
IPF is a disease that damages the air sacs in the lungs and leads to widespread and
permanent scarring of lung tissue. Individuals with IPF may experience breathing
difficulties, cough, chest pain, and a decreased exercise capacity. There is no cure for
this disease, and individuals usually die within 3 to 5 years. It is recommended that
individuals with IPF engage in moderate exercise, as this can help maintain strength and
improve lung function. Many individuals with IPF also suffer from pulmonary hypertension,
which is high blood pressure in the arteries leading to the lungs. Sildenafil, a medication
currently used to treat pulmonary hypertension, increases blood flow to the lungs and
enhances gas exchange within the lungs. The purpose of this study is to evaluate the
effectiveness of sildenafil at improving exercise tolerance and breathing difficulties in
individuals with IPF and pulmonary hypertension.
This 3-week study will enroll individuals with IPF and pulmonary hypertension. Study visits
will occur at baseline, and Weeks 1 and 2. At the baseline visit, participants will perform
a 6-minute walk test, which will measure the distance walked in a 6-minute period. Oxygen
levels will be measured prior to and during the test, and standardized questionnaires will
be completed to assess breathing difficulties. A second 6-minute walk test will be performed
1 hour following the first test. At the Week 1 visit, participants will be randomly assigned
to receive a single dose of either 50 mg of sildenafil or placebo. One hour after receiving
the medication, they will complete another 6-minute walk test. The Week 2 visit will be
identical to the Week 1 visit, except participants who received sildenafil at Week 1 will
receive placebo at Week 2, and vice versa.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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