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Completed

NCT Number: NCT02763735

Right Ventricular Metabolism in Pulmonary Arterial Hypertension

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Healthy Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Right ventricular oxygen consumption divided by the rate pressure product

    Time frame: At time of C11 acetate PET scan

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

Secondary outcomes

  1. Right ventricular oxygen consumption (kmono)

    Time frame: At time of C11 acetate PET scan

  2. Right ventricular glucose uptake (standardized uptake value)

    Time frame: At time of 18-FDG PET scan

  3. Percent myocardial triglyceride content

    Time frame: 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

    Time frame: Day 1

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

    Time frame: Day 1

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

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Metabolic Intervention in the Right Ventricle in Pulmonary Arterial Hypertension

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 5, 2016
Registry last updated
May 20, 2020

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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