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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
University of Maryland
Yale University
Washington University School of Medicine
The Cardiovascular Medical Research and Education Fund
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01917136
First received: August 3, 2013
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
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. We will also 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.

Condition Intervention Phase
Pulmonary Hypertension
Drug: 11C-acetate
Drug: [18F]Fluoro-2-deoxy-2-D-glucose
Other: Cardiac MRI
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Myocardial oxygen consumption, FDG uptake, and myocardial perfusion [ Time Frame: baseline ]
    Compare Myocardial oxygen consumption, FDG uptake, and myocardial perfusion at baseline for subjects with normal right ventricular function and those with persistent right ventricular dysfunction

  • Myocardial oxygen consumption and FDG uptake and myocardial perfusion [ Time Frame: 6 months ]
    Assess change from baseline in Myocardial oxygen consumption and FDG uptake and myocardial perfusion in subjects with persistent right ventricular dysfunction who are treated with ranolazine or placebo


Secondary Outcome Measures:
  • Changes in myocardial structure and function [ Time Frame: 6 months ]
    Using CMR, comparing myocardial structure and function in patients treated with ranolazine or placebo


Estimated Enrollment: 36
Study Start Date: August 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 11c-acetate and 18F-FDG, and cardiac MRI
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
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate
Drug: [18F]Fluoro-2-deoxy-2-D-glucose
For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG
Other Name: 18F-FDG
Other: Cardiac MRI
Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917136

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Brigham and Women's Hospital
University of Maryland
Yale University
Washington University School of Medicine
The Cardiovascular Medical Research and Education Fund
Investigators
Principal Investigator: Yuchi Han, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01917136     History of Changes
Obsolete Identifiers: NCT01953965
Other Study ID Numbers: 817786
Study First Received: August 3, 2013
Last Updated: August 29, 2016

Keywords provided by University of Pennsylvania:
pulmonary hypertension
right ventricular function
11C acetate
FDG
ranolazine

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017