Right Ventricular Metabolism in Pulmonary Arterial Hypertension

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02763735
Collaborator
(none)
34
1
60
0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to use non-invasive imaging to determine the metabolic phenotype of the right ventricle in patients with pulmonary arterial hypertension across a spectrum of disease severity.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Current medical therapy for pulmonary arterial hypertension (PAH) is aimed at reducing pulmonary vascular resistance (PVR) but not ameliorating right ventricular (RV) failure, the major cause of death. There are no RV-specific therapies currently available for PAH, in part because the pathophysiology of RV failure is poorly understood.

    The investigators hypothesize that the RV in PAH develops a distinct metabolic pattern characterized by increased glycolysis, impaired oxidative metabolism and lipid deposition, which are associated with RV failure.

    Specific Aim 1. To test the hypothesis that the RV in human PAH exhibits lipid deposition, increased glycolysis and impaired fatty acid oxidation. The investigators will measure RV oxidative metabolism and glycolysis in PAH patients and controls using positron emission tomography 11C acetate and [18F]fluoro-deoxy-D-glucose imaging and measure myocardial lipid accumulation using magnetic resonance spectroscopy imaging.

    Specific Aim 2. To test the hypothesis that an abnormal RV metabolic profile is associated with RV dysfunction and reduced exercise capacity in PAH. PET and MRS findings will be correlated with RV function, patient exercise capacity and a blood metabolic profile.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    34 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Metabolic Intervention in the Right Ventricle in Pulmonary Arterial Hypertension
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2019
    Actual Study Completion Date :
    Jun 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Pulmonary Arterial Hypertension

    Patients diagnosed with idiopathic or heritable pulmonary arterial hypertension according to consensus guidelines. RV oxidative metabolism and glycolysis will be measured using PET 11C acetate and [18F]fluoro-deoxy-Dglucose (FDG) imaging and measure myocardial lipid accumulation using MRS imaging.

    Subjects without cardiopulmonary disease

    Subjects without known cardiopulmonary disease. RV oxidative metabolism and glycolysis will be measured using PET 11C acetate and [18F]fluoro-deoxy-Dglucose (FDG) imaging and measure myocardial lipid accumulation using MRS imaging

    Outcome Measures

    Primary Outcome Measures

    1. Right ventricular oxygen consumption divided by the rate pressure product [At time of C11 acetate PET scan]

      kmono divided by the rate pressure product (heart rate X systolic blood pressure)

    Secondary Outcome Measures

    1. Right ventricular oxygen consumption (kmono) [At time of C11 acetate PET scan]

    2. Right ventricular glucose uptake (standardized uptake value) [At time of 18-FDG PET scan]

    3. Percent myocardial triglyceride content [At time of cardiac magnetic resonance imaging]

      Percent of myocardial triglyceride measured in the interventricular septum

    4. Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with right ventricular function [Day 1]

    5. Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with six minute walk distance [Day 1]

    6. Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with plasma metabolic profile [Day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Heritable or idiopathic PAH

    • 18 years or older

    • Able to give informed consent

    Exclusion Criteria:
    • Pregnancy

    • Type 1 diabetes mellitus

    • Prednisone use

    • PAH associated with any condition other than idiopathic or heritable

    • Implanted ferromagnetic material incompatible with MRI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Vanderbilt University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Evan Brittain, Assistant Professor of Medicine, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02763735
    Other Study ID Numbers:
    • 131271
    First Posted:
    May 5, 2016
    Last Update Posted:
    May 20, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Evan Brittain, Assistant Professor of Medicine, Vanderbilt University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 20, 2020