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Completed

NCT Number: NCT01917136

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

11C-Acetate

Drug

For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate

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

Drug

For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG

Other names: 18F-FDG

Cardiac MRI

Other

Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

Primary outcomes

  1. Changes in RV Function

    Time frame: 6 months

    RV function as measured by cardiac MRI

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Brigham and Women's Hospital
  • The Cardiovascular Medical Research and Education Fund
  • University of Maryland
  • Washington University School of Medicine
  • Yale University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2013
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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