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Prenatal Aspirin and Postpartum Vascular Function
Plain-language guide to NCT05653973: early phase 1 interventional trial of Endothelin-1, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05653973
- Phase
- early phase 1
- Status
- recruiting participants
- Start
- 2023-01-03
- Completion (planned or actual)
- 2027-03-31
- Participants
- 60 (estimated)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Preeclampsia; Microvascular Function
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered early phase 1 trial tested Endothelin-1.
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.
It had 1 arm (groups): assessment of microvascular function (experimental).
The investigators use intradermal microdialysis to deliver acetylcholine, acetylcholine + L-NAME, endothelin-1, endothelin-1 + BQ-788, and endothelin-1 + BQ-123 to the cutaneous microvasculature.
The registry classes the interventions as drug.
Who Took Part
60 planned participants were the target.
It was open to women only aged from 18 years up to 50 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: 18 years or older,. 12 weeks to 5 years postpartum. And one of the following:. Women who had a normal pregnancy and did not use low does aspirin (LDA) during pregnancy,. Women who had a normal pregnancy and used LDA during pregnancy,.
The full record lists 19 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Endothelin-1 study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-01-03 with completion listed for 2027-03-31.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): microvascular endothelial function (time frame: at the study visit, an average of 4 hours). microvascular endothelin-1-mediated constriction (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 trial of Endothelin-1 in 60 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Endothelin-1 compound page, all human trials.
Our Notes on the Compound
Endothelin-1: A 21-amino-acid peptide and one of the strongest blood-vessel constrictors in the body; given in research studies of vascular function.
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.