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

Phase 4

Withdrawn

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Device: St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT); Device: Boston Scientific Intravascular Ultrasound

• Registration Number: NCT01508780
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Study Start: 2012-05
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Arterial Hypertension, bosentan	St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)	Subjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan.
Pulmonary Arterial Hypertension, bosentan	Boston Scientific Intravascular Ultrasound	Subjects include patients being diagnosed with pulmonary arterial hypertension and starting treatment with bosentan.

Primary Outcome Measures

Name	Time	Method
Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months	Baseline and 4 months

Secondary Outcome Measures

Name	Time	Method
Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 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	Baseline and 4 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States