Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan
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|ClinicalTrials.gov Identifier: NCT01051960|
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : November 2, 2020
Last Update Posted : November 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis Shortness of Breath Pulmonary Hypertension||Drug: Ambrisentan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot Study|
|Actual Study Start Date :||March 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||January 2011|
ambrisentan dosed at either 5mg or 10mg orally once per day
Ambrisentan 5mg or 10mg once daily
Other Name: Letairis
- Change in Exercise Pulmonary Hemodynamics From Baseline to Week 24 [ Time Frame: 24 weeks ]We defined ePH (exercise PH) as an mPAP of 30 mmHg, PCWP of 18 mm Hg, and a transpulmonary gradient (TPG) of 15 mm Hg, where TPG equals mPAP minus PCWP. We defined ePVH (exercise pulmonary venous hypertension) as an mPAP of 30 mm Hg, PCWP of 18 mm Hg, and a TPG of 15 mm Hg. We defined eoPH (exercise out of proportion) as an mPAP of 30 mm Hg, PCWP of 18 mm Hg, and a TPG of 15 mm Hg (4). Our hypothesis was that SSc patients with normal exercise physiology and ePVH have a different patho-physiology compared to patients with pulmonary vascular disease (ePH and eoPH).
- Change in Distance Walked in Six Minutes From Baseline to 24 Week [ Time Frame: 24 weeks ]ATS guideline based assessment with known minimally clinically important difference
- Quality of Life (QOL) Based on SF36 and HAQ-DI [ Time Frame: 24 weeks ]Number of participants exceeding minimally important difference estimates on changes in quality of life as assessed by SF-36 (short form 36) quality of life index with mental and physical component scores, or by HAQ-DI (health assessment questionnaire disability index) limitations that may be related to musculoskeletal limitations
- HAQ-DI (Health Assessment Questionnaire Disability Index) [ Time Frame: 24 weeks ]Assessing limitations that may be related to musculoskeletal limitations, the HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items in which level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The 8 domain scores are averaged into a total HAQ-DI score ranging from 0 (no disability) to 3 (completely disabled).
- St. George's Respiratory Questionnaire [ Time Frame: 24 weeks ]To assess overall health, daily life, and perceived well-being in patients with underlying lung disease, the SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.
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): NCT01051960
|United States, California|
|David Geffen School of Medicine, University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Rajeev Saggar, MD||University of California, Los Angeles|
|Principal Investigator:||Dinesh Khanna, MD||University of California, Los Angeles|