DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

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

Phase: Phase 4

Status: Withdrawn

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Ik-Kyung Jang, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Change in the measurement of Pulmonary arterial intimal + Medial thickening by OCT pre and post treatment with bosentan at 4 months

Secondary outcome:

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

Change in pulmonary arterial pressure/elastic strain index by IVUS pre and post treatment with bosentan at 4 months

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Starting date: May 2012
Last updated: February 11, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017