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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01508780
• Other study ID #: 2011P000916
• Status: Withdrawn
• Phase: Phase 4
• First received: January 3, 2012
• Last updated: February 11, 2014
• Start date: May 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Device:
• St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)
All subjects will have OCT and IVUS imaging during their right heart catheterization.
• Boston Scientific Intravascular Ultrasound
All subjects will have OCT and IVUS imaging during their right heart catheterization.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in pulmonary arterial pulsatility by IVUS pre and post treatment with bosentan at 4 months		Baseline and 4 months	No
Secondary	Change in pulmonary arterial pressure/elastic strain index by IVUS pre and post treatment with bosentan at 4 months		Baseline and 4 months	No