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Withdrawn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

Intervention / Treatment

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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:

  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

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.
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.

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

Massachusetts General Hospital

Collaborators

Actelion

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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