Status:
WITHDRAWN
Combined Use of Angiography, Optical Coherence Tomography and Intravascular Ultrasound in Evaluation of Pulmonary Vascular Structure and Function in Patients With Pulmonary Arterial Hypertension Treated With Oral Bosentan
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
It has been hypothesized that one of the benefits of bosentan relates to pulmonary vascular remodeling. The investigators believe that this study will help document the nature of beneficial changes th...
Detailed Description
Subjects will have Optical coherence tomography (OCT) and Intravascular Ultrasound (IVUS) imaging during the right heart catheterization that diagnoses them as having PAH. Subjects will start their bo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- WHO GROUP 1
- AGE 18-75
- Baseline 6-min walk distance (6MWD) between 200 and 450 m
- Diagnosed with pulmonary artery hypertension during right heart catheterization (Mean Pulmonary Artery Pressure \> 25mmHg)
- General Exclusion Criteria
- Pregnant or nursing
- Acute or chronic illness other than those associated with PAH (collagen vascular disease, human immunodeficiency virus, or anorexigen use)
- Previously received any investigational medications, prostanoids, or phosphodiesterase inhibitors
- eGFR \< 60
- Angina
- Syncope
- Failing right ventricle
- Hemoptysis
Exclusion
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01508780
Start Date
May 1 2012
End Date
February 1 2014
Last Update
February 13 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114