- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01508780
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
February 11, 2014 updated by: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
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.
Study Overview
Status
Withdrawn
Conditions
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.
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pulmonary Arterial Hypertension, bosentan
Subjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan.
|
All subjects will have OCT and IVUS imaging during their right heart catheterization.
All subjects will have OCT and IVUS imaging during their right heart catheterization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months
Time Frame: Baseline and 4 months
|
Baseline and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months
Time Frame: Baseline and 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
Time Frame: Baseline and 4 months
|
Baseline and 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
January 3, 2012
First Submitted That Met QC Criteria
January 9, 2012
First Posted (Estimate)
January 12, 2012
Study Record Updates
Last Update Posted (Estimate)
February 13, 2014
Last Update Submitted That Met QC Criteria
February 11, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011P000916
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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