Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05462574
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2022-07-14
Brief Title:
Right Ventricle Lipid in Pulmonary Arterial Hypertension PAH
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Clinical and Mechanistic Understanding of Right Ventricular Steatosis in Pulmonary Arterial Hypertension PAH
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 metabolomiclipidomic 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
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 metabolomiclipidomic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HL155278 | OTHER_GRANT | NHLBI | None |