Hypertension Clinical Trial
Official title:
Linking the Maternal Immune System to Cardiac Function in Preeclampsia
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 | Recruiting |
Enrollment | 100 |
Est. completion date | July 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - Singleton pregnancy - Live fetus at 11-13 weeks of gestation - Informed, written consent Exclusion Criteria: - Unwilling or unable to give consent - Pre-eclamptic women with pre-existing conditions |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Barts Health NHS Trust, The Royal London Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | Barts & The London NHS Trust, British Heart Foundation |
United Kingdom,
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
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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