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NCT04632589 · ClinicalTrials.gov registry record · Early Phase 1
Losartan for Improved Vascular Endothelial Function After Preeclampsia
A Early Phase 1 study, sponsored by Anna Stanhewicz, PhD.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT04632589: Completed Early Phase 1 study, sponsored by Anna Stanhewicz, PhD.
NCT04632589 is a Early Phase 1 study that has completed, run by Anna Stanhewicz, PhD. The registered enrollment target is 11 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04632589, a Early Phase 1 study, has completed, sponsored by Anna Stanhewicz, PhD.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage and to test whether taking a medication that blocks angiotensin II receptors (losartan) decrease these negative effects in women who have had preeclampsia. Identification of these mechanisms and treatment strategies may lead to better clinical management,of cardiovascular disease risk in these women. In this study we use the blood vessels in the skin as a representative vascular bed. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickle-sized area of the skin in women who have had preeclampsia. We make these measurements after the subjects take a placebo and after they take losartan (an angiotensin II receptor blocker) to test whether this treatment improves vascular function in these women. As a compliment to these measurements, we also draw blood from the subjects and isolate the inflammatory cells to test how sensitive their inflammatory responses are following the placebo and the losartan treatment.
Primary Outcome
Cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry during intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME. Cutaneous conductance is calculated (laser-Doppler flux/mean arterial pressure) and normalized to site specific maximal dilation (%maximum).
Interventions
- DRUG Placebo
- DRUG Losartan Potassium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-11-22 |
| Est. Completion | 2025-03-13 |
| Phase | Early Phase 1 |
What the finished NCT04632589 record still lists
NCT04632589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04632589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04632589 about?
NCT04632589 is a clinical study titled "Losartan for Improved Vascular Endothelial Function After Preeclampsia". Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclampt...
What is the current status of trial NCT04632589?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2020-11-22. Estimated completion is 2025-03-13.
What interventions are being tested in trial NCT04632589?
The interventions under investigation include: Placebo (DRUG), Losartan Potassium (DRUG).
Who is sponsoring clinical trial NCT04632589?
This trial is sponsored by Anna Stanhewicz, PhD, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04632589's enrollment target sits among peer trials
11 1600th of 2000 higher than 373 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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