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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.