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临床试验/NCT04632589
NCT04632589已完成早期 1 期

Angiotensin II Receptor Inhibition to Improve Microvascular Function in Women Who Have Had Preeclampsia

Anna Stanhewicz, PhD1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年11月22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
已完成
发起方
入组人数
11
试验地点
1
主要终点
Cutaneous Conductance (%Maximum) Response to Acetylcholine

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 blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage and to test whether taking a medication that blocks angiotensin II receptors (losartan) decrease these negative effects in women who have had preeclampsia. Identification of these mechanisms and treatment strategies may lead to better clinical management,of cardiovascular disease risk in these women.

In this study we use the blood vessels in the skin as a representative vascular bed. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickle-sized area of the skin in women who have had preeclampsia. We make these measurements after the subjects take a placebo and after they take losartan (an angiotensin II receptor blocker) to test whether this treatment improves vascular function in these women. As a compliment to these measurements, we also draw blood from the subjects and isolate the inflammatory cells to test how sensitive their inflammatory responses are following the placebo and the losartan treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Post-partum women,
  • 18 years or older,
  • who have delivered within 24 months of the study visit
  • who have had a preeclamptic pregnancy diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for preeclampsia. [This information will be self-reported by the subjects.]
  • Using an effective method of birth control and not planning to become pregnant in the next 6 months.

排除标准

  • skin diseases,
  • current tobacco use,
  • diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2,
  • statin or other cholesterol-lowering medication,
  • current antihypertensive medication,
  • history of hypertension prior to pregnancy,
  • history of gestational diabetes,
  • current pregnancy or breastfeeding,
  • body mass index <18.5 kg/m2,
  • allergy to materials used during the experiment.(e.g. latex),
  • known allergies to study drugs.

研究组 & 干预措施

Losartan

Experimental

6 weeks of daily (50mg/day) oral losartan potassium tablet

干预措施: Losartan Potassium (Drug)

Placebo

Placebo Comparator

6 weeks of daily oral placebo tablet

干预措施: Placebo (Drug)

结局指标

主要结局

Cutaneous Conductance (%Maximum) Response to Acetylcholine

时间窗: immediately following 6 weeks of oral treatment (losartan or placebo)

Cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry during intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME. Cutaneous conductance is calculated (laser-Doppler flux/mean arterial pressure) and normalized to site specific maximal dilation (%maximum).

Cutaneous Conductance (%Baseline) Response to Angiotensin II

时间窗: immediately following 6 weeks of oral treatment (losartan or placebo)

Cutaneous vascular constrictor response to exogenous ang II perfusion; measured by laser-Doppler flowmetry during intradermal microdialysis delivery of angiotensin II. Cutaneous conductance is calculated (laser-Doppler flux/mean arterial pressure) and normalized to site-specific baseline conductance (%baseline) measured on the study day before the perfusion of angiotensin II.

次要结局

未报告次要终点

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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