RecruitingNot Applicable

Right Ventricle Lipid in Pulmonary Arterial Hypertension (PAH)

United States75 participantsStarted 2023-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * ≥ 18 years old * Diagnosed with idiopathic, heritable, connective tissue disease-associated PAH, associated pulmonary arterial hypertension (PAH), or drug-or toxin-associated PAH according to World Health Organization (WHO) consensus recommendations. * Stable PAH-specific medication regimen for three months prior to enrollment. Adjustments in IV prostacyclin for side effect management are allowed. Diuretic adjustments are permitted. * WHO Functional Class I-III * Ambulatory * Able to have an MRI/MRS, perform a 6MWD test, and cardiopulmonary exercise test Exclusion criteria: * Pregnancy * Diagnosis of PAH etiology other than idiopathic, heritable, connective tissue disease - associated PAH or associated with drugs and toxins * WHO Functional class IV heart failure * Requirement for continuous oxygen * Unable to have an MRI/MRS, perform a 6MWD test, or cardiopulmonary exercise test. * Patients with implanted/embedded ferromagnetic material that would preclude cardiac MRI

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Right Ventricular (RV) Ejection Fraction

Timeframe: Baseline to 36 months

Change in Right Ventricular (RV) Lipid Content

Timeframe: Baseline to 36 months

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

Timeframe: Baseline to 36 months

Ratio of BMPR2 isoform B/A.

Timeframe: Baseline to 36 months

Change in skeletal muscle lipid content.

Timeframe: Baseline to 36 months

Trial details

NCT IDNCT05462574

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-30

Contact for this trial

Natasha Billard

(434) 851-3306 natasha.billard.1@vumc.org

View on ClinicalTrials.gov More Idiopathic Pulmonary Arterial Hypertension trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Right Ventricular (RV) Ejection Fraction

Timeframe: Baseline to 36 months

Change in Right Ventricular (RV) Lipid Content

Timeframe: Baseline to 36 months

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

Timeframe: Baseline to 36 months

Ratio of BMPR2 isoform B/A.

Timeframe: Baseline to 36 months

Change in skeletal muscle lipid content.

Timeframe: Baseline to 36 months