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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

This study has been withdrawn prior to enrollment.
(Due to complex study protocol, no patients have been enrolled in the study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01508780
First Posted: January 12, 2012
Last Update Posted: February 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Actelion
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
January 3, 2012
January 12, 2012
February 13, 2014
May 2012
February 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01508780 on ClinicalTrials.gov Archive Site
  • Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
 
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
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
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Pulmonary Arterial Hypertension
  • Device: St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)
    All subjects will have OCT and IVUS imaging during their right heart catheterization.
  • Device: Boston Scientific Intravascular Ultrasound
    All subjects will have OCT and IVUS imaging during their right heart catheterization.
Experimental: Pulmonary Arterial Hypertension, bosentan
Subjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan.
Interventions:
  • Device: St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)
  • Device: Boston Scientific Intravascular Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01508780
2011P000916
Not Provided
Not Provided
Not Provided
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Massachusetts General Hospital
Actelion
Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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