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临床试验/NCT05937841
NCT05937841招募中早期 1 期

Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia

Anna Stanhewicz, PhD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry

研究概览

简要总结

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 impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy 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 the microvascular differences in women who have had preeclampsia following activation of protective angiotensin receptors in the skin. This will help increase understanding of the mechanisms of angiotensin II receptors in these women, and how activation 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women who had preeclampsia and women who did not have preeclampsia
  • 12 weeks to 5 years postpartum
  • 18-45 years old

排除标准

  • history of hypertension or metabolic disease before pregnancy
  • history of gestational diabetes
  • 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 kg/m2
  • allergy to materials used during the experiment.(e.g. latex),
  • known allergy to study drugs

研究组 & 干预措施

assessment of microvascular function

Experimental

The investigators use intradermal microdialysis to deliver compound 21 and L-NAME to the cutaneous microvasculature

干预措施: Compound 21 (Drug)

结局指标

主要结局

Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry

时间窗: post 1 hour of skin perfusion

Cutaneous vascular vasodilator response (cutaneous conductance; %max) to exogenous compound 21 perfusion; intradermal microdialysis for the local delivery of compound 21

Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry

时间窗: post 1 hour of skin perfusion

Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of compound 21 compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response

次要结局

  • Angiotensin receptor expression in endothelial cells(a total of 1 time during the study, within ~4 weeks following enrollment)

研究者

发起方
Anna Stanhewicz, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anna Stanhewicz, PhD

Assistant Professor

University of Iowa

研究点 (1)

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