Preeclampsia Associated Vascular Aging

Pre-Eclampsia Clinical Trial

— PAVA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04484766
• Other study ID #: 2019-1498
• Status: Active, not recruiting
• Start date: September 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Other:
• Primary data collection
Primary data collection takes place via questionnaires outside the study centre. All other investigations take place at the study centre: Physical examination: height, weight, BMI, blood pressure Cardiac examination: cardiac output Vascular measurements: Carotid intima media thickness, total peripheral resistance, blood pressure, flow-mediated vascular dilatation, critical flicker frequency, pulse wave velocity, augmentation index Serum analysis: basic laboratory, multiplex analysis (human vascular inflammation, human angiogenesis and adhesion molecule panel)

Locations

Country	Name	City	State
Germany	Universitätsklinikum Jena	Jena	Thüringen

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular health as combined outcome	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	1 day 10-20 years after pregnancy
Primary	Potential long-term effect of PETN treatment using combined outcome of vascular health measurements in correlaation with treatment with PETN	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	1 day 10-20 years after pregnancy
Primary	Endothelial cell senescence using senescence characterization of young and treated HUVEC cells	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	1 day 10-20 years after pregnancy