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NCT04769206 · ClinicalTrials.gov registry record · Phase 1
Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans
A Phase 1 study of Endothelial Dysfunction, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04769206: Active Phase 1 study of Endothelial Dysfunction, sponsored by Vanderbilt University Medical Center.
NCT04769206 is a Phase 1 study of Endothelial Dysfunction that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 46 participants, below the 91-participant average among 45 other Endothelial Dysfunction trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04769206, a Phase 1 study of Endothelial Dysfunction, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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. Sub-study (optional) Will study the effect of trans-auricular vagus nerve stimulation (TaVNS) during a period of enhanced vascular oxidative stress 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.
Primary Outcome
flow mediated dilation
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Galantamine
- DEVICE TENS 7000
Study Locations (1)
Tennessee
- Chaney Johnson - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 1 |
What the registry record for NCT04769206 still lists
NCT04769206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 91-participant average among 45 other Endothelial Dysfunction trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Endothelial Dysfunction appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04769206 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04769206 about?
NCT04769206 is a clinical study titled "Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans". 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 fo...
What is the current status of trial NCT04769206?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2021-12-20. Estimated completion is 2026-07-30.
What conditions does trial NCT04769206 study?
This clinical trial studies the following conditions: Endothelial Dysfunction.
What interventions are being tested in trial NCT04769206?
The interventions under investigation include: Placebo (DRUG), Galantamine (DRUG), TENS 7000 (DEVICE).
Who is sponsoring clinical trial NCT04769206?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04769206 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04769206's enrollment target sits among peer trials
46 23rd of 45 higher than 23 of 45 other Endothelial Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endothelial Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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