Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans - Trial NCT04769206
Access comprehensive clinical trial information for NCT04769206 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Vanderbilt University Medical Center and is currently Recruiting. The study focuses on Endothelial Dysfunction. Target enrollment is 88 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Vanderbilt University Medical Center
Timeline & Enrollment
Phase 1/2
Dec 20, 2021
Dec 31, 2028
Primary Outcome
FMD,NADPH activation in PBMC
Summary
Specific Aim 1: To test the hypothesis that prolonged (3-month) treatment with galantamine
 inhibits NADPH IsoLG-protein adducts formation and improves markers of endothelial cell (EC)
 dysfunction in AAs.
 
 Aim 1a: The investigators will determine if galantamine inhibits NADPH IsoLG-protein adducts
 formation, superoxide production, and immune cell activation compared to placebo.
 
 For this purpose, the investigators will study peripheral blood mononuclear cell (PBMC), a
 critical source of systemic oxidative stress, collected from study participants.
 
 Aim 1b: The investigators will determine if galantamine reduces intracellular Iso-LGs,
 ICAM-1, and 3-nitrotyrosine, a marker of vascular oxidative stress, in ECs harvested from
 study participants.
 
 Specific Aim 2: To determine if prolonged (3-month) treatment with galantamine improves
 endothelial dysfunction as measured by vascular reactivity in AAs. The investigators will
 measure vascular reactivity in response to ischemia in two vascular beds: (a) in conduit
 arteries (brachial artery) using brachial artery diameter flow-mediated dilation (FMD), and
 (b) in the microvasculature (MBV) using contrast-enhanced ultrasonography in skeletal muscle.
 
 This proposal will study a novel mechanism that could alter the oxidative and immunogenic
 responses that contributes to endothelial dysfunction in AAs and will offer a potential
 pathway for the development of more effective therapies aimed at decreasing the progression
 of endothelial dysfunction to cardiovascular disease in this population.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04769206
Non-Device Trial