Cardiovascular Risk After Preeclampsia

NCT05277233 | Recruiting

• 1 other identifier: CARPE
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress Magnetic Resonance Imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after healthy pregnancies.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Myocardial perfusion

  Measured by adenosine stress Magnetic Resonance Imaging (ml/min/g)

  Day 2

Secondary Outcomes (18)

• Cardiac fibrosis

  Day 2

• Immune cell phenotypes

  Day 1

• Concentration of N-terminal prohormone of brain natriuretic peptide

  Day 1

• Concentration of brain natriuretic peptide

  Day 1

• Urinary protein

  Day 1

Study Arms (3)

Early-onset preeclampsia

Defined as preeclampsia that develops before 34 weeks of gestation

Late-onset preeclampsia

Defined as preeclampsia that develops after 34 weeks of gestation

Control

Healthy pregnancies, matched to early and late-onset cases

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Woman 5-15 years after pregnancy

You may qualify if:

• Women
• years
• years postpartum

You may not qualify if:

• Atrioventricular block, chronic obstructive pulmonary disease, bronchial asthma
• Pregnancy and/or active breastfeeding
• Glaucoma disease, epilepsy
• In addition for MRI: metal implants, electric devices, intolerance of contrast media, claustrophobia, renal or hepatic dysfunction (GFR \< 30 ml/min)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Experimental and Clinical Research Center

Berlin, 13125, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, peripheral blood mononuclear cells (PBMCs)

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anja Mähler, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Kräker, PhD

CONTACT

+49 30 450540 328; kristin.kraeker@charite.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 14, 2022
• Study Start: April 4, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

DE (1)