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

NCT01508780 | Withdrawn Phase 4

• 1 other identifier: 2011P000916
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Pulmonary Arterial Hypertension, bosentan

EXPERIMENTAL

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

Device: St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT); Device: Boston Scientific Intravascular Ultrasound

Interventions

St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT) DEVICE

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

Pulmonary Arterial Hypertension, bosentan

Boston Scientific Intravascular Ultrasound DEVICE

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

Pulmonary Arterial Hypertension, bosentan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• WHO GROUP 1
• AGE 18-75
• Baseline 6-min walk distance (6MWD) between 200 and 450 m
• Diagnosed with pulmonary artery hypertension during right heart catheterization (Mean Pulmonary Artery Pressure \> 25mmHg)

You may not qualify if:

• Pregnant or nursing
• Acute or chronic illness other than those associated with PAH (collagen vascular disease, human immunodeficiency virus, or anorexigen use)
• Previously received any investigational medications, prostanoids, or phosphodiesterase inhibitors
• eGFR \< 60
• Angina
• Syncope
• Failing right ventricle
• Hemoptysis

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Actelion: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ik-Kyung Jang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: January 12, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

US (1)