11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.

Detailed Description
-----------------
We will measure right ventricular metabolic and structural changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). This is a companion imaging trial for patients who are eligible for the treatment trial entitled 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. Subjects must enroll in companion treatment protocol to qualify for the imaging protocol. The cardiac MRI portion of the study continued, but the PET portion of the study was discontinued due to funding. The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed study was registered under NCT02829034.

Official Title
-----------------
Evaluation of Regional Myocardial Perfusion, Glucose Utilization and Oxidative Metabolism in Patients With Pulmonary Hypertension Using Combined [11C]Acetate and [18F]Fluorodeoxyglucose (FDG) PET/CT and Cardiovascular MRI

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: 11C-acetate
* Drug: [18F]Fluoro-2-deoxy-2-D-glucose
* Other: Cardiac MRI


Participation Criteria
=================
Eligibility 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. Severe anxiety or claustrophobia prohibiting completion of imaging Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET) Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI. Uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 11c-acetate and 18F-FDG, and cardiac MRI<br>For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed. | Drug: 11C-acetate<br>* For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate<br>Drug: [18F]Fluoro-2-deoxy-2-D-glucose<br>* For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG<br>* Other names: 18F-FDG;Other: Cardiac MRI<br>* Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in RV Function | RV function as measured by cardiac MRI | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary hypertension, right ventricular function, 11C acetate, FDG, ranolazine