Clinical trial NCT04484766: Preeclampsia Associated Vascular Aging
Official title: Preeclampsia Associated Vascular Age- Long-term Follow-up and New Prevention Strategy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pre-eclampsia 10 to 20 years ago. The patients are matched with the next consenting patient who gave birth without pregnancy complications. Only singleton pregnancies born between the 24th and 42nd week of pregnancy are considered.

Patients with and without PETN treatment are recruited from the patients who participated in the PETN pilot study from 2002 to 2008. In addition, patients are recruited who received PETN treatment as a personalised therapy trial. These are matched by patients without treatment. The matching includes the indication for treatment, the week of pregnancy at diagnosis and the percentiles of fetal growth

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.

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

Primary outcomes:
measure: vascular health as combined outcome
timeFrame: 1 day 10-20 years after pregnancy
measure: Potential long-term effect of PETN treatment using combined outcome of vascular health measurements in correlaation with treatment with PETN
timeFrame: 1 day 10-20 years after pregnancy
measure: Endothelial cell senescence using senescence characterization of young and treated HUVEC cells
timeFrame: 1 day 10-20 years after pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
Study officials:
affiliation: Klinik für Geburtsmedizin
name: Anna Multhaup, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: