Preeclampsia Associated Vascular Age- Long-term Follow-up and New Prevention Strategy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- vascular health as combined outcome
研究概览
简要总结
To evaluate cardiovascular health, especially endothelial health, of women after pre-eclampsia compared to women without pre-eclampsia, and to compare women who had taken PETN during pregnancy with women who had not attempted treatment
详细描述
The clinical observation that women with pre-eclampsia have a high risk of early onset cardiovascular disease with increased disease-associated mortality has led to the hypothesis that the endothelial status of these women is characterized by early onset of aging. We want to investigate the relationship between endothelial aging and pregnancy disorders such as pre-eclampsia, which are dominated by endothelial dysfunction. Do endothelial changes precede pregnancy and cause pre-eclampsia and later accelerated cardiovascular aging, or does pre-eclampsia trigger premature endothelial aging in affected individuals for the first time? The aim of this study is to investigate the cardiovascular health of women 10 to 20 years after pre-eclampsia and to compare it with that of women with uneventful pregnancies. In addition, the potential long-term endothelial protective effect of the NO-donor pentaerithrityltetranitrate (PETN) is investigated.
This in vivo study will be extended in vitro by the analysis of senescence induction in endothelial cells after pre-eclampsia associated stress. Additionally, the potential protective effect of PETN on stress-induced senescence will be evaluated.
The ultimate goal is to establish a prospective long-term study on the effect of PETN on vascular health in women with pre-eclampsia to assess whether treatment of endothelial dysfunction during pregnancy could reduce endothelial aging and thus premature cardiovascular morbidity and mortality in millions of women.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants of the PETN pilot study from 2002-2008
- •controls: uneventful pregnancies from 2002-2008
- •Patients with pre-eclampsia with PETN treatment 10-20 years ago
- •Controls: patients with pre-eclampsia without PETN treatment 10-20 years ago
- •Written Informed Consent
- •Singleton pregnancy
- •Exclusion criteria:
- •Patients who refuse to participate in the study
- •Impossibility of the outpatient presentation
排除标准
- 未提供
结局指标
主要结局
vascular health as combined outcome
时间窗: 1 day 10-20 years after pregnancy
Comparison of the vascular health of patients after pre-eclampsia with that of women with complication-free pregnancies 10-20 years after pregnancy by assessing physical parameters (height, weight, Blood pressure, bioelectric impedance analysis), measuring cardiac output, transthoracic echocardiography, carotid intima media thickness, total vascular resistance, flow mediated dilation, critical flicker frequency, puls-wave velocity and augmentation index
Potential long-term effect of PETN treatment using combined outcome of vascular health measurements in correlaation with treatment with PETN
时间窗: 1 day 10-20 years after pregnancy
Analysis of a possible long-term effect of PETN treatment during pregnancy based on a vascular health comparison of patients who received PETN in the PETN pilot study from 2002 to 2008, or who received it in a personalised therapy trial, with those who received placebo or no therapy
Endothelial cell senescence using senescence characterization of young and treated HUVEC cells
时间窗: 1 day 10-20 years after pregnancy
In vitro analysis of endothelial cell senescence established by hosting group after pre-eclampsia induced stress effect, as well as the possible protective effect of PETN on endothelial cell aging
次要结局
未报告次要终点