Preeclampsia Associated Vascular Aging

NCT ID: NCT04484766

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-06-30

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.

Conditions

Pre-Eclampsia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient after pre-eclampsia

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

Primary data collection

Intervention Type: OTHER

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)

Patients after PETN treatment

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

Primary data collection

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

Physical examination; Cardiac measurement; Vascular Measurement; Serum analysis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Multhaup, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Geburtsmedizin

Locations

Universitätsklinikum Jena

Jena, Thuringia, Germany

Countries

Germany

Other Identifiers

2019-1498

Identifier Type: -

Identifier Source: org_study_id