Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT01953965
• Date of registration: 26/09/2013
• Prospective Registration: No
• Primary sponsor: Brigham and Women's Hospital
• Public title: Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.
• Scientific title: 11C-acetate/18Fluorodeoxyglucose-FDG PET/Cardiac MRI in Pulmonary Hypertension
• Date of first enrolment: September 2013
• Target sample size: 4
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01953965
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Aaron Waxman, MD, PhD
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participation in the companion treatment protocol "A randomized, double-blind,
placebo-controlled, multi-center study to assess the effect of ranolazine on outcomes
in subjects with pulmonary hypertension and right ventricular dysfunction accompanied
by a comparative study of cellular metabolism in subjects with pulmonary hypertension
with and without right ventricular dysfunction".

Exclusion Criteria:

- Pregnancy or lactation: Women of childbearing potential must have a negative urine or
blood pregnancy test on the day of the PET/CT scan.

- Anxiety or claustrophobia prohibiting completion of imaging

- Inability to tolerate imaging procedures (up to 2 hours on scanner)

- Moderate to severe chronic renal disease defined as an estimated glomerular
filtration rate < 30 ml/min/1.73m2

- Implantable cardioverter-defibrillator, pacemaker, hazardous metallic implants or any
other contraindication to MRI

- History of uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL at the
treatment protocol screening visit.



Age minimum: 18 Years
Age maximum: 72 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Chronic Thromboembolic Pulmonary Hypertension

Intervention(s)

Drug: 11C-acetate

Drug: [18F]Fluoro-2-deoxy-2-D-glucose

Drug: MultiHance

Primary Outcome(s)

2. To measure changes in RV energy and contractility in subjects with persistent RV dysfunction using serial 11C-acetate and 18F-FDG PET/CT and CMR. perfusion [Time Frame: Baseline to 6 months]

1. To demonstrate that there are differences in metabolism and function between subjects with near normal RV function and persistent RV dysfunction as defined by CMR Right Ventricular Ejection Fraction (RVEF) of <= 40%. [Time Frame: baseline and 6 months]

Secondary Outcome(s)

Changes in myocardial structure and function [Time Frame: 6 months]

Secondary ID(s)

CMREF-PH Imaging

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Pennsylvania

University of Maryland

Yale University