Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|