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NCT04508582Completed

Cardiac and Immune Cell Function in Preeclampsia

Linking the Maternal Immune System to Cardiac Function in Preeclampsia

Source: ClinicalTrials.gov · Last updated 10 Mar 2025

Brief summary (registry, in English)

Preeclampsia is a multi-system vascular disease which affects 2-5% of pregnancies. It is also a risk factor for the development of cardiovascular disease later in life and a number of functional and structural cardiac changes have been found in this population of patients. In mouse models disruption of a group of immune cells, neutrophils, has led to alteration of the placenta and offspring consistent with those seen in preeclampsia. These mice also have an abnormal cardiac function and structure (Nadkarni et al 2016). The investigators hypothesis that this may also occur in humans. This study aims to intimately link the maternal immunological and vascular components of cardiac dysfunction in women preeclampsia. The investigators hypothesise that in preeclampsia activated neutrophils may affect maternal immune system thus leading to myocardial injury and altered cardiac function. The study intends to identify the mechanisms by which the maternal immune system (focusing on neutrophil and T-cell subsets) affects cardiac function in women with preeclampsia. Specific aims to be addressed are: Aim 1: To correlate specific neutrophil phenotype(s) and function to cardiac function in women with preeclampsia during pregnancy Aim 2: To test whether specific activated neutrophil phenotype persists postpartum and whether this neutrophil phenotype correlates with cardiac function in women with preeclampsia postpartum The study population will comprise of 3 groups: 1. Normotensive pregnant (\~33 patients) 2. Pregnancy-induced hypertension (PIH; New-onset hypertension after 20 weeks without proteinuria; \~33 patients) 3. Preeclampsia (\~34 patients) Cardiac function will be evaluated using cardiovascular magnetic resonance, echocardiography and cardiac markers in the blood. The participants immune system will be assessed from blood samples looking at the immune cells, hormone levels and inflammatory and non-inflammatory mediators. The secondary research objective is to investigate whether changes in the immune system and cardiac function in participants is persistent after delivery. Therefore participants will have scans and blood tests both antenatally and at 3 months postnatally. By identifying key changes in immune cell type and function with cardiac abnormalities in women with preeclampsia, data obtained from this study could provide novel insight into how the maternal immune system influences cardiac changes in normal and preeclamptic pregnancies. Identifying such links could pave the way for future therapeutic targets.

Status (registry)
Completed
Study type
Observational
Enrollment
86 (actual)
First submitted
7 Aug 2020
Start date
Jan 2020
Primary completion date
Mar 2024
Lead sponsor
Queen Mary University of London
NCT number
NCT04508582

What you commit to

  • Study type: Observational
  • Participants enrolled: 86
  • From Jan 2020 to the primary completion date, Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Pre-eclamptic women with pre-existing conditions

Other

  • Unwilling or unable to give consent

Who the study is looking for

  • Age \> 18 years
  • Singleton pregnancy
  • Live fetus at 11-13 weeks of gestation
  • Informed, written consent

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Barts Health NHS Trust , The Royal London Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.