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Clinical Trials/NCT05462574
NCT05462574
Recruiting
Not Applicable

Clinical and Mechanistic Understanding of Right Ventricular Steatosis in Pulmonary Arterial Hypertension (PAH)

Vanderbilt University Medical Center1 site in 1 country75 target enrollmentJanuary 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Pulmonary Arterial Hypertension
Sponsor
Vanderbilt University Medical Center
Enrollment
75
Locations
1
Primary Endpoint
Change in Right Ventricular (RV) Ejection Fraction
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

The investigators propose to study the relationship between right ventricle (RV) steatosis and RV function, exercise capacity, and outcomes in humans with pulmonary arterial hypertension (PAH) and to identify potential drivers of lipid accumulation.

Detailed Description

The investigators propose to test the hypothesis that abnormal lipid metabolism in PAH leads to delivery of fatty acids in excess of RV oxidative capacity, resulting in steatosis and lipotoxicity. The objectives of the study are to: 1) Define the relationships between RV steatosis, RV function, and exercise capacity; 2) Identify mechanistic drivers of RV steatosis including BMPR2 expression and lipid metabolism; 3) Examine lipid metabolism in PAH skeletal muscle as a potential driver of reduced functional capacity. In Aim 1 (clinical relevance) the investigators will measure RV and left ventricle (LV) lipid in participants with heritable, idiopathic, and scleroderma- associated PAH. Participants will undergo the 6-minute walk test, cardiopulmonary exercise testing, and will be followed for clinical events. A subgroup will undergo repeat MRS at four timepoints over three years to determine the natural history of steatosis. In Aim 2 (mechanism), the investigators will perform metabolomic/lipidomic profiling of peripheral and coronary sinus plasma and measure BMPR2 expression to identify potential drivers of steatosis. In Aim 3 (specificity), the investigators will perform MRS on skeletal muscle in Aim 1 participants and matched healthy controls to clarify the systemic effects of lipid metabolic defects in PAH.

Registry
clinicaltrials.gov
Start Date
January 17, 2023
End Date
September 30, 2027
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Evan Brittain

Associate Professor of Medicine

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Right Ventricular (RV) Ejection Fraction

Time Frame: Baseline to 36 months

Change in RV ejection fraction will be measured by cardiac MRI.

Change in Right Ventricular (RV) Lipid Content

Time Frame: Baseline to 36 months

Change in RV lipid content will be measured by cardiac proton magnetic resonance spectroscopy (MRS). Lipid content is expressed as a percent of the voxel occupied by lipid.

Ratio of BMPR2 isoform B/A.

Time Frame: Baseline to 36 months

BMPR2 isoforms A and B and wild type gene expression will be measured by real-time polymerase chain reaction (PCR) and validated by measuring protein content using Western blot test.

Change in skeletal muscle lipid content.

Time Frame: Baseline to 36 months

Change in skeletal muscle lipid content will be measured by skeletal muscle proton MRS. Lipid content is expressed as percent triglyceride (%TG)

Identification of metabolic markers (dihyroxybutyrate, acetylputriscene, hydroxystearate and glucuronate) in the peripheral circulation and coronary sinus.

Time Frame: Baseline to 36 months

Metabolite markers will be measured by ultrahigh performance liquid chromatography and mass spectrometry.

Study Sites (1)

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