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Due to complex study protocol, no patients have been enrolled in the study.
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| Name | Class |
|---|---|
| Actelion | INDUSTRY |
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 that occur in patients with Pulmonary Arterial Hypertension (PAH) in response to bosentan therapy. In turn, demonstrating that changes in pulmonary vascular structure and function accompany clinical improvement.
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 bosentan and will be followed by monthly clinic visits for 4 months. At 4 months they will have repeat OCT and IVUS imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Arterial Hypertension, bosentan | Experimental | Subjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT) | Device | All subjects will have OCT and IVUS imaging during their right heart catheterization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months | Baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months | Baseline and 4 months | |
| Change in pulmonary arterial pressure/elastic strain index by IVUS pre and post treatment with bosentan at 4 months | Baseline and 4 months |
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Inclusion Criteria:
General Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ik-Kyung Jang, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Boston Scientific Intravascular Ultrasound | Device | All subjects will have OCT and IVUS imaging during their right heart catheterization. |
|
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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