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This study has been withdrawn prior to enrollment.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:
Collaborator:
Actelion
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01508780
First received: January 3, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Device: St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)
Device: Boston Scientific Intravascular Ultrasound
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulmonary Arterial Hypertension, bosentan
Subjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan.
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508780

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Actelion
Investigators
Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01508780     History of Changes
Other Study ID Numbers: 2011P000916
Study First Received: January 3, 2012
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014