This study is designed to assess safety and efficacy of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension. Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
20mg/day for one month then 40mg/day for additional 4 months
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
6 Minute Walk Distance
Time frame: Baseline, Week 8, Week 16, Week 24
Resting Oxygen Saturation
Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state.
Time frame: Baseline, Week 24
Oxygen Desaturation During 6 Minute Walk Test
Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test
Time frame: Baseline, Week 24
Maximum Borg Dyspnea Score During 6 Minute Walk Test
The modified Borg scale consists of a vertical scale labelled 0 to10 with corresponding verbal expressions of progressively increasing sensation (shortness of breath) intensity. 0 represents no dyspnea, and 10 is the highest level of perceived dyspnea.
Time frame: Baseline, Week 8, Week 16, Week 24
Brain Natriuretic Peptide Level
Time frame: Baseline, Week 8, Week 16, Week 24
Short Form-36 Global Score
SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The global score is determined by taking an average of the individual domain scores. The global score range is from 0 (worst) to 100 (best).
Time frame: Baseline, Week 8, Week 16, Week 24
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St. George's Respiratory Questionnaire (SGRQ) Score
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Time frame: Baseline, Week 8, Week 16, Week 24
Number of Participants With Change in WHO Functional Class (WHO FC)
The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). Higher scores indicate more severe impairment.
Time frame: Baseline, Week 24