Investigating Lipid Accumulation in the Right Ventricle of Patients with Pulmonary Arterial Hypertension
Clinical and Mechanistic Understanding of Right Ventricular Steatosis in Pulmonary Arterial Hypertension (PAH)
This study is trying to see how fat buildup in the right side of the heart affects the health and exercise ability of people with pulmonary arterial hypertension.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05462574 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between right ventricle (RV) lipid accumulation and RV function, exercise capacity, and clinical outcomes in patients with pulmonary arterial hypertension (PAH). The study will measure lipid levels in the RV and left ventricle, assess exercise capacity through tests like the 6-minute walk test, and analyze potential drivers of lipid accumulation, including BMPR2 expression and lipid metabolism. Participants will be followed over time to understand the natural history of RV steatosis and its impact on health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with idiopathic, heritable, or connective tissue disease-associated PAH who are stable on their medication regimen.
Not a fit: Patients with functional class IV heart failure or those unable to undergo necessary testing such as MRI/MRS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of pulmonary arterial hypertension, potentially enhancing patient outcomes.
How similar studies have performed: While the specific focus on RV lipid accumulation in PAH is novel, related studies have shown promising results in understanding lipid metabolism in cardiovascular diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Evan Brittain, MD, MSCI — Vanderbilt University Medical Center
- Study coordinator: Natasha Billard
- Email: natasha.billard.1@vumc.org
- Phone: (434) 851-3306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.