Preeclampsia Associated Vascular Aging (PAVA)

Jena University Hospital

Status: Active, not recruiting

Conditions: Pre-Eclampsia

Treatments: Other: Primary data collection

Study type: Observational

Funder types: Other

Identifiers

NCT04484766

2019-1498

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Patient after pre-eclampsia

Description:

Patients with pre-eclampsia who were treated at the University Hospital of Jena between 1999-2009.

Treatment:

Other: Primary data collection

Patients after PETN treatment

Description:

Patients of the PETN pilot study, with PETN and patients who received PETN as an individual therapy trial

Treatment:

Other: Primary data collection