Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Hypertension Using Positron Emission Tomography Imaging

NCT01461343 | Completed

• 1 other identifier: 2011-P-001880/1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find out how the blood flow changes in the lungs of people with pulmonary hypertension compared to healthy individuals without pulmonary hypertension. We would like to find out if there are differences in how blood flows when subjects are given a drug to dilate (widen) the arteries in their lungs and when they breathe extra oxygen. We will compare the results to when subjects don't receive any drug or extra oxygen. We hope that knowing about these differences will help us to better understand pulmonary hypertension and how to diagnose it earlier.

Conditions

Pulmonary Arterial Hypertension

Keywords

pulmonary hypertension, PET imaging, CT/PET

Outcome Measures

Primary Outcomes (1)

• Coefficient of variation of perfusion

  Images will be generated with positron emission tomography that will be used to calculate the degreee to which the blood flow in the lung is patchy rather than smooth. The statistical measure of this is called the coefficient of variation.

  One imaging visit lasting up to 3 hours

Secondary Outcomes (2)

• Vascular compliance

  One imaging visit lasting up to 3 hours

• Perfusion gradient

  One imaging visit lasting up to 3 hours

Study Arms (2)

pulmonary hypertension

EXPERIMENTAL

Patients with Group I pulmonary arterial hypertension and exercise-induced pulmonary hypertension to undergo CT imaging, functional PET imaging

Other: CT imaging, functional PET imaging

healthy controls

ACTIVE COMPARATOR

healthy adults to serve as controls and to undergo the same study procedures: CT imaging, functional PET imaging

Other: CT imaging, functional PET imaging

Interventions

CT imaging, functional PET imaging OTHER

Physiology study using CT and functional PET imaging with 13NN and 11CO as radiotracers; images obtained before and after administration of inhaled nitric oxide and balance 80% oxygen as pulmonary vasodilators

healthy controls; pulmonary hypertension

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General
• A signed and dated written informed consent is obtained from the subject.
• The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Available to complete the study.
• Able to lie flat and able to perform a 30 second breath hold.
• Patients with Pulmonary Hypertension
• Subject is male or female aged = or \> 18 years of age and \< or = 70 years.
• Subject is diagnosed with pulmonary arterial hypertension (WHO Group I, by right heart catheterization, mean PA pressure \> 25 and PCWP \< 15) or exercise-induced pulmonary hypertension (by right heart catheterization + Level III cardiopulmonary exercise testing, mean PAP \> 30 and PCWP \< 20 during exercise, but normal at rest), with the most recent of above diagnostic tests taking place within 12 months of study entry.
• If patient has been on PAH-specific therapy, the therapy (agent and dose) has been unchanged for at least 3 months.

You may not qualify if:

• General
• FEV1 and/or TLC \< 70% predicted
• PCWP \> 15 mm Hg
• Inability to perform the study (by primary MD or investigator assessment)
• Subjects who have a past or present disease, which as judged by the Investigators may affect the outcome of this study
• The subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit.
• The subject has a positive pregnancy test.
• The subject is unable to perform the respiratory manoeuvres necessary for the exam.
• The subject has been exposed to a radiation dose over the past year that, when added to the radiation dose expected in this study, would exceed permissible yearly exposure as determined by the MGH radiation safety committee.
• Subjects with Pulmonary Hypertension
• Subject with clinical instability in the judgment of the investigator, or hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study.
• Subjects in whom PAH therapy has been escalated (additional agent started) within 3 months of enrolment.
• Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, or COPD.
• Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• R. Scott Harris, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician, Massachusetts General Hospital; Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 28, 2011
• Study Start: February 1, 2013
• Primary Completion: November 21, 2017
• Study Completion: March 15, 2018
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

US (1)