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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Pulmonary Arterial Hypertension, bosentan

Subjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan.

Group Type EXPERIMENTAL

St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)

Intervention Type DEVICE

All subjects will have OCT and IVUS imaging during their right heart catheterization.

Boston Scientific Intravascular Ultrasound

Intervention Type DEVICE

All subjects will have OCT and IVUS imaging during their right heart catheterization.

Interventions

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St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)

All subjects will have OCT and IVUS imaging during their right heart catheterization.

Intervention Type DEVICE

Boston Scientific Intravascular Ultrasound

All subjects will have OCT and IVUS imaging during their right heart catheterization.

Intervention Type DEVICE

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No