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临床试验/NCT07715669
NCT07715669招募中1 期

Role of Antidepressant Therapy to Improve Vascular Function After Preeclampsia

Anna Stanhewicz, PhD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年8月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry

研究概览

简要总结

Preeclampsia is a condition in pregnancy where a woman develops high blood pressure and other complications. Women who develop preeclampsia are 4 times more likely to have heart disease later in life. They are also more likely to have depression after pregnancy. Why they are more likely to develop these conditions is not known. It may be because their blood vessels were damaged during pregnancy. Changes in blood vessel health can predict heart disease. These changes have been recorded after pregnancy in women who had preeclampsia. These changes have also been recorded in women who have depression. In the previous phase of this award, we found that women who had preeclampsia in pregnancy had changes in blood vessel health after pregnancy. We also found that if these women were taking a medicine to treat depression, their blood vessel health was normal. This could mean that treatment for depression can also increase blood vessel health in women who had preeclampsia. In this project we will study how changes in blood vessel health are related to preeclampsia and depression in women who have had both. We will also study how medicine to treat depression can improve blood vessel health after preeclampsia. We will do this by measuring how blood vessels work in women who have had preeclampsia compared to women who did not, and in women who have depression and women who do not. This will tell us more about why risk for depression and heart disease is higher in women who have had preeclampsia. It will also help us understand if medicine for depression can reduce cardiovascular disease risk after preeclampsia.

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

  • 18-24 years old,
  • 12 weeks - 5 years post pregnancy
  • one of the following:
  • history of a normal pregnancy with a current diagnosis of depression,
  • history of a normal pregnancy without a current diagnosis of depression,
  • history of a preeclamptic pregnancy with a current diagnosis of depression
  • history of preeclamptic pregnancy without a current diagnosis of depression.

排除标准

  • history of cardiovascular, metabolic, and/or skin diseases
  • current or history of tobacco/nicotine/ e-cigarette use
  • history of gestational diabetes
  • current antihypertensive or cholesterol-lowering medication
  • currently pregnant
  • allergy to materials used during the experiment (e.g. latex),
  • known allergy to study drugs
  • currently using SSRI medications

研究组 & 干预措施

Cutaneous Vascular Response to Local Heat

Experimental

All women will complete the same protocol, regardless of pregnancy history and depression status.

Four intradermal microdialysis fibers will be placed in the ventral forearm for the local delivery of: (1) lactated Ringer's (control), (2) paroxetine HCl, (3) ascorbic acid, or (4) paroxetine HCl + ascorbic acid. Skin blood flow will be measured with laser-Doppler flowmetry directly over each microdialysis fiber during a standard local heating protocol to 42 degrees Celsius. Once a stable plateau in blood flow has been reached, each site is perfused with L-NAME to inhibit nitric oxide synthase. Following a post-L-NAME plateau, maximal dilation is induced by perfusing sodium nitroprusside and increasing local temperature to 43 degrees Celsius.

干预措施: Ascorbic acid (Vitamin C) (Drug)

Cutaneous Vascular Response to Local Heat

Experimental

All women will complete the same protocol, regardless of pregnancy history and depression status.

Four intradermal microdialysis fibers will be placed in the ventral forearm for the local delivery of: (1) lactated Ringer's (control), (2) paroxetine HCl, (3) ascorbic acid, or (4) paroxetine HCl + ascorbic acid. Skin blood flow will be measured with laser-Doppler flowmetry directly over each microdialysis fiber during a standard local heating protocol to 42 degrees Celsius. Once a stable plateau in blood flow has been reached, each site is perfused with L-NAME to inhibit nitric oxide synthase. Following a post-L-NAME plateau, maximal dilation is induced by perfusing sodium nitroprusside and increasing local temperature to 43 degrees Celsius.

干预措施: Paroxetine Hydrochloride (Drug)

结局指标

主要结局

Microvascular endothelium-dependent dilation response measured by laser-Doppler flowmetry

时间窗: at the study visit, an average of 4 hours

Cutaneous vascular conductance responses to local heating over a microdialysis fiber receiving treatments compared to lactated Ringer's solution (control).

Nitric oxide-dependent dilation response measured by laser-Doppler flowmetry

时间窗: at the study visit, an average of 4 hours

Difference in cutaneous vascular conductance between local heating plateau and post-L-NAME plateau within each treated microdialysis site compared to lactated Ringer's (control).

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

Associate Professor

University of Iowa

研究点 (1)

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