Clinical trial NCT01917136: 11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
right ventricular function
11C acetate
FDG
ranolazine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: University of Maryland
name: Yale University
name: Washington University School of Medicine
name: The Cardiovascular Medical Research and Education Fund
First posted: 2013-08-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Changes in RV Function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Yuchi Han, MD
role: PRINCIPAL_INVESTIGATOR
References: