A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (ATPAHSS)
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|ClinicalTrials.gov Identifier: NCT01042158|
Recruitment Status : Completed
First Posted : January 5, 2010
Results First Posted : September 12, 2017
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension Systemic Sclerosis Scleroderma Spectrum of Diseases Connective Tissue Disease Pulmonary Hypertension||Drug: tadalafil and ambrisentan upfront combination therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Tadalafil and ambrisentan upfront therapy
This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).
Drug: tadalafil and ambrisentan upfront combination therapy
tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study.
- Right Ventricular (RV) Mass [ Time Frame: baseline and 36 weeks ]Assessment of change in Right ventricular mass was done via standard volumetric cine images of the right heart at baseline and comparing it to that at the end of 36 weeks using Cardiac Magnetic Resonance Imaging studies.
- Pulmonary Vascular Resistance (PVR) [ Time Frame: baseline 36 weeks ]Change in Pulmonary Vascular Resistance (PVR) was ascertained via Right Heart Catheterization (RHC) measurement of the difference between the PVR at baseline and 36 weeks
- Tricuspid Annular Plane Systolic Excursion (TAPSE) [ Time Frame: baseline and 36 weeks ]The extent of displacement of the tricuspid valves, termed as Tricuspid Annular Plane Systolic Excursion (TAPSE) was measured using a trans-thoracic echocardiogram following Right heart catheterization.
- 6-minute Walk Distance [ Time Frame: baseline and 36 weeks ]patients were made to take a walk of normal speed to cover a distance in 6 minutes and distance covered was recorded. This was done at baseline (week o) and then repeated t 36 weeks.
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): NCT01042158
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Paul Hassoun, MD||Johns Hopkins University|