Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01884051
Status:
RECRUITING
Last Update Posted:
2023-09-01
First Post:
2013-01-15
Brief Title:
Hormonal Metabolic and Signaling Interactions in PAH
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Hormonal Metabolic and Signaling Interaction in Pulmonary Arterial Hypertension
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Our hypothesis is that optimal treatment of the dysfunctional metabolic pathways which underlie PAH will improve pulmonary vascular function and consequences of the disease
Detailed Description:
Project 1 This project will work to understand why women are affected by pulmonary arterial hypertension PAH so much more often than men This observation is true in heritable idiopathic and associated forms of PAH While males and females have some similar hormone levels certain hormones exist at higher levels in each gender For example estrogen levels are much higher in females and thus seemed the most sensible place to start looking for differences that may be affecting disease In a small early study of our heritable patients we found differences in how patients break down estrogens as compared to healthy control subjects Now we want to confirm that what we found is true in a much larger group of patients that includes idiopathic and associated forms of PAH We will also look to see if testosterone and other androgenic hormones are somehow protective for males If the observation holds true in the larger group of patients then we may try to fix the hormone imbalance in a mouse model of PAH with a drug therapy and see if it helps improve the mouse pulmonary hypertension without bad side effects to the animals If the animal drug studies work then we may be able to try this drug in patients to see if it will work as a human treatment
Project 2 Despite major advances in understanding PAH in recent decades safe effective and tolerable therapies remain elusive The metabolic syndrome central obesity insulin resistance high blood pressure and hyperlipidemia-fats in the blood has been implicated in PAH Treating the downstream consequences of insulin resistance in the pulmonary vasculature is a new approach to effective intervention against this highly mortal disease This project will study the role of insulin resistance in pulmonary arterial hypertension and determine if therapies to treat insulin resistance will improve pulmonary arterial hypertension
Project 3 In Project 3 we are working on the theory that PAH can be treated by fixing cell-cell junctions in blood vessels with a drug called recombinant ACE2angiotensin converting enzyme 2 This is the only approach so far that has worked to reverse disease in mouse models of heritable PAH but we need to better understand how it is working and make sure it has long term safety in animal models before starting human trials hopefully within a few years Definition Cell-cell junctions-all of our organs and body structures are made from cells Normally these cells think of a balloon filled with water line up right next to each other so that the cell membranes touch each other Materials can flow from one cell to the next In PAH patients it is believed that the cells in the linings of the small arteries are not able to line up together as they should
Project 2 Despite major advances in understanding PAH in recent decades safe effective and tolerable therapies remain elusive The metabolic syndrome central obesity insulin resistance high blood pressure and hyperlipidemia-fats in the blood has been implicated in PAH Treating the downstream consequences of insulin resistance in the pulmonary vasculature is a new approach to effective intervention against this highly mortal disease This project will study the role of insulin resistance in pulmonary arterial hypertension and determine if therapies to treat insulin resistance will improve pulmonary arterial hypertension
Project 3 In Project 3 we are working on the theory that PAH can be treated by fixing cell-cell junctions in blood vessels with a drug called recombinant ACE2angiotensin converting enzyme 2 This is the only approach so far that has worked to reverse disease in mouse models of heritable PAH but we need to better understand how it is working and make sure it has long term safety in animal models before starting human trials hopefully within a few years Definition Cell-cell junctions-all of our organs and body structures are made from cells Normally these cells think of a balloon filled with water line up right next to each other so that the cell membranes touch each other Materials can flow from one cell to the next In PAH patients it is believed that the cells in the linings of the small arteries are not able to line up together as they should
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None