Clinical trial

Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia

Name
202309383
Description
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. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage caused by reduced endothelial function in women who have had preeclampsia compared to women who had a healthy pregnancy. Identification of these mechanisms and treatment strategies may lead to better clinical management of cardiovascular disease risk in these women. The purpose of this study is to examine differences in the microvascular balance of angiotensin II receptors women who have had preeclampsia. This will help the investigators better understand the mechanisms of dysregulated angiotensin II receptors in formerly preeclamptic women, and how activation or inhibition of these receptors may restore microvascular function. In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) the investigators examine the blood vessels in a dime-sized area of the skin.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-11-01
Trial end
2024-11-01
Status
Recruiting
Phase
Early phase I
Treatment
Compound 21
differences in vasodilation to compound 21 in the skin between groups
Arms:
History of a healthy pregnancy, History of a preeclampsia
Angiotensin II
differences in vasoconstriction to angiotensin II in the skin between groups
Arms:
History of a healthy pregnancy, History of a preeclampsia
Size
30
Primary endpoint
Change in microvascular angiotensin II (ang II) type 2 receptor (AT2R)-mediated dilation response measured by laser-Doppler flowmetry
at the study visit, an average of 4 hours
Change in microvascular ang II-mediated constriction response measured by laser-Doppler flowmetry
at the study visit, an average of 4 hours
Eligibility criteria
Inclusion Criteria: * women who had preeclampsia and women who did not have preeclampsia * 12 weeks to 5 years postpartum * 18-45 years old Exclusion Criteria: * history of hypertension or metabolic disease before pregnancy * history of gestational diabetes or gestational hypertension * skin diseases * current tobacco use * current antihypertensive medication * statin or other cholesterol-lowering medication * currently pregnant or planning to become pregnant * body mass index less than \<18.5 or \>30 kg/m2 * allergy to materials used during the experiment.(e.g. latex), * known allergy to study drugs
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-05-13

1 organization

2 products

1 indication

Organization
Anna Stanhewicz
Indication
Preeclampsia