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
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Arterial Hypertension
Intervention: St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT) (Device); Boston Scientific Intravascular Ultrasound (Device)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Ik-Kyung Jang, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital
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 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.
Clinical Details
Official title: 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
Study design: Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months
Secondary outcome: Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 monthsChange in pulmonary arterial pressure/elastic strain index by IVUS pre and post treatment with bosentan at 4 months
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 bosentan and will be followed by monthly clinic visits for 4 months. At 4
months they will have repeat OCT and IVUS imaging.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. WHO GROUP 1
2. AGE 18-75
3. Baseline 6-min walk distance (6MWD) between 200 and 450 m
4. Diagnosed with pulmonary artery hypertension during right heart catheterization (Mean
Pulmonary Artery Pressure > 25mmHg)
General Exclusion Criteria
1. Pregnant or nursing
2. Acute or chronic illness other than those associated with PAH (collagen vascular
disease, human immunodeficiency virus, or anorexigen use)
3. Previously received any investigational medications, prostanoids, or
phosphodiesterase inhibitors
4. eGFR < 60
5. Angina
6. Syncope
7. Failing right ventricle
8. Hemoptysis
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: May 2012
Last updated: February 11, 2014
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