Right Ventricular Metabolism in Pulmonary Arterial Hypertension

Healthy Clinical Trial

Official title:

Metabolic Intervention in the Right Ventricle in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763735
• Other study ID #: 131271
• Status: Completed
• Start date: June 2014
• Est. completion date: June 2019

Study information

• Verified date: May 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Healthy
• Hypertension
• Pulmonary Arterial Hypertension

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular oxygen consumption divided by the rate pressure product	kmono divided by the rate pressure product (heart rate X systolic blood pressure)	At time of C11 acetate PET scan
Secondary	Right ventricular oxygen consumption (kmono)		At time of C11 acetate PET scan
Secondary	Right ventricular glucose uptake (standardized uptake value)		At time of 18-FDG PET scan
Secondary	Percent myocardial triglyceride content	Percent of myocardial triglyceride measured in the interventricular septum	At time of cardiac magnetic resonance imaging
Secondary	Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with right ventricular function		Day 1
Secondary	Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with six minute walk distance		Day 1
Secondary	Correlation of kmono, kmono/RPP, FDG uptake, and myocardial triglyceride content with plasma metabolic profile		Day 1