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Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia
Plain-language guide to NCT06157580: early phase 1 non-randomized trial of Angiotensin II, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06157580
- Phase
- early phase 1
- Status
- completed
- Start
- 2023-12-08
- Completion (planned or actual)
- 2024-10-24
- Participants
- 24 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Preeclampsia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (early phase 1) is built around Angiotensin II.
Otherwise healthy women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life.
The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during preeclampsia and persists postpartum, despite the remission of clinical symptoms.
It had two arms (groups): History of a preeclampsia (other) and History of a healthy pregnancy (other).
Women who had preeclampsia in their most recent pregnancy.
Women who had an uncomplicated pregnancy.
The registry classes the interventions as drug.
Who Took Part
The registry lists 24 actual participants took part.
It was open to women only aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Women who had preeclampsia and women who did not have preeclampsia. 12 weeks to 5 years postpartum. 18-45 years old.
The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: history of hypertension or metabolic disease before pregnancy; history of gestational diabetes or gestational hypertension; skin diseases.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
The Angiotensin II group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Angiotensin II study: the participants and staff both knew the treatment.
It started in 2023-12-08 with completion listed for 2024-10-24.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Change in microvascular angiotensin II (ang II) type 2 receptor (AT2R)-mediated dilation response measured by laser-Doppler flowmetry (time frame: at the study visit, an average of 4 hours). Change in microvascular ang II-mediated constriction response measured by laser-Doppler flowmetry (time frame: at the study visit, an average of 4 hours).
What This Means in Plain Language
Put simply, this is a early phase 1, non-randomized trial of Angiotensin II in 24 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Angiotensin II compound page, all human trials.
Our Notes on the Compound
Angiotensin II: An 8-amino-acid hormone that narrows blood vessels; synthetic angiotensin II (Giapreza) is used for low blood pressure in shock.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.