Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)
|ClinicalTrials.gov Identifier: NCT01324999|
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Tadalafil||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tadalafil for Sarcoidosis Associated Pulmonary Hypertension|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Sarcoid Associated Pulm. Hypertension
Single-arm open-label proof of concept study of tadalafil in patients with sarcoidosis associated pulmonary hypertension.
20mg/day for one month then 40mg/day for additional 4 months
- 6 Minute Walk Distance [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
- Resting Oxygen Saturation [ Time Frame: Baseline, Week 24 ]Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state.
- Oxygen Desaturation During 6 Minute Walk Test [ Time Frame: Baseline, Week 24 ]Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test
- Maximum Borg Dyspnea Score During 6 Minute Walk Test [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]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.
- Brain Natriuretic Peptide Level [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
- Short Form-36 Global Score [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]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).
- St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
- Number of Participants With Change in WHO Functional Class (WHO FC) [ Time Frame: Baseline, Week 24 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324999
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Hubert J Ford, M.D.||University of North Carolina, Chapel Hill|