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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04508582
Other study ID # IRAS 281197
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 25, 2020
Est. completion date July 31, 2025

Study information

Verified date April 2024
Source Queen Mary University of London
Contact Alice P Christensen
Phone 020 7882 8235
Email a.p.christensen@qmul.ac.uk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Diagnostic Test:
Cardiovascular magnetic resonance
Imaging of the heart with CMR, without use of contrast agents.
Echocardiography
Imaging of the heart with ultrasound.
Blood test
Time- matched blood samples will be taken from patients to assess immune cell phenotype and function, paying particular attention to neutrophil and T-cell phenotype. Plasma samples will be collected for the analyses of cardiac specific factors (BNP, troponin) as well as measurement of steroid hormones (progesterone and oestradiol), and soluble inflammatory and anti-inflammatory mediators

Locations

Country Name City State
United Kingdom Barts Health NHS Trust, The Royal London Hospital London

Sponsors (3)

Lead Sponsor Collaborator
Queen Mary University of London Barts & The London NHS Trust, British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Bellenger NG, Davies LC, Francis JM, Coats AJ, Pennell DJ. Reduction in sample size for studies of remodeling in heart failure by the use of cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2000;2(4):271-8. doi: 10.3109/10976640009148691. — View Citation

Grothues F, Smith GC, Moon JC, Bellenger NG, Collins P, Klein HU, Pennell DJ. Comparison of interstudy reproducibility of cardiovascular magnetic resonance with two-dimensional echocardiography in normal subjects and in patients with heart failure or left ventricular hypertrophy. Am J Cardiol. 2002 Jul 1;90(1):29-34. doi: 10.1016/s0002-9149(02)02381-0. — View Citation

Herrey AS, Francis JM, Hughes M, Ntusi NAB. Cardiovascular magnetic resonance can be undertaken in pregnancy and guide clinical decision-making in this patient population. Eur Heart J Cardiovasc Imaging. 2019 Mar 1;20(3):291-297. doi: 10.1093/ehjci/jey162. — View Citation

Nadkarni S, Smith J, Sferruzzi-Perri AN, Ledwozyw A, Kishore M, Haas R, Mauro C, Williams DJ, Farsky SH, Marelli-Berg FM, Perretti M. Neutrophils induce proangiogenic T cells with a regulatory phenotype in pregnancy. Proc Natl Acad Sci U S A. 2016 Dec 27;113(52):E8415-E8424. doi: 10.1073/pnas.1611944114. Epub 2016 Dec 12. — View Citation

Wenger NK. Recognizing pregnancy-associated cardiovascular risk factors. Am J Cardiol. 2014 Jan 15;113(2):406-9. doi: 10.1016/j.amjcard.2013.08.054. Epub 2013 Oct 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Immune function and cardiac function in preeclampsia To correlate maternal immune cell phenotype(s) and function to cardiac function in women with preeclampsia 3 years
Secondary Postpartum immune function and cardiac function in preeclampsia To investigate whether specific maternal immune cell phenotype(s) and altered cardiac function in women with PE persist in the post-partum period (up to 3 months after delivery). 3 years
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