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Clinical Trials/NCT04484766
NCT04484766
Active, not recruiting
Not Applicable

Preeclampsia Associated Vascular Age- Long-term Follow-up and New Prevention Strategy

Jena University Hospital1 site in 1 country120 target enrollmentSeptember 1, 2019
ConditionsPre-Eclampsia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-Eclampsia
Sponsor
Jena University Hospital
Enrollment
120
Locations
1
Primary Endpoint
vascular health as combined outcome
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

vascular health as combined outcome

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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