At the Heart of the Matter - Speckle Tracking Echocardiography in Lupus Mothers and Their Offspring
1 other identifier
observational
120
1 country
1
Brief Summary
Women with systemic lupus erythematosus (SLE) have a high risk of placenta-mediated complications, which can lead to substantial cardiac morbidities in affected women and their offspring. In addition, maternal autoantibodies, which are actively transferred across the placenta during pregnancy, can affect the cardiovascular health of SLE offspring. Hydroxychloroquine (HCQ) is effective in preventing adverse pregnancy outcomes in SLE and might be beneficial in preventing fetal cardiovascular damage mediated by maternal autoantibodies. However, there are concerns that HCQ might cause maternal and neonatal cardiac toxicity. A novel imaging technique (i.e. speckle tracking echocardiography), which allows early identification of cardiac dysfunction, has proven superior to any other in assessing cardiac function in mothers and neonates experiencing placenta-mediated complications and in identifying drug cardiotoxicity. Yet, there has been no study using speckle tracking echocardiography to evaluate the cardiovascular health of pregnant SLE women and their offspring, as well as the potential adverse cardiac effect of HCQ. Moreover, due to unavailability of assays, HCQ dosing in SLE is generally done blindly, without checking drug levels. To fill these key knowledge gaps, the investigators aim to: 1) assess the impact of placenta-mediated complications on maternal and neonatal cardiac function, 2) evaluate if HCQ exposure (as measured by whole-blood levels) is associated with maternal and neonatal outcomes including cardiac toxicity, and 3) determine the effect of maternal autoantibodies on neonatal cardiac function. Ultimately, our proposal will help optimize reproductive and cardiovascular outcomes in lupus women and their offspring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedAugust 11, 2022
August 1, 2022
2.5 years
June 23, 2022
August 8, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Maternal cardiac function [i.e., global longitudinal (myocardial) strain (GLS) measured by speckle tracking echocardiography (STE)]
Maternal global longitudinal strain (GLS) measured by speckle tracking echocardiography (STE) will be compared between early pregnancy and postpartum, between pregnant SLE women with and without adverse outcomes, and between SLE and controls in early pregnancy and postpartum stratifying by adverse outcome status. GLS determined by STE will be measured using a 2-D and 3-D STE software (i.e. TomTec Arena). For evaluation of strain, the endocardial border will be traced, at end-systole in the appropriate imaging plane. Peak GLS will be measured by the software using an average of 2 consecutive cardiac cycles. Measures will be repeated twice to calculate intra-observer intraclass correlation coefficient (ICC). Another blinded investigator will review STE assessments to calculate the inter-observer ICC.
2 years
Neonatal cardiac function [i.e., global longitudinal (myocardial) strain (GLS) measured by speckle tracking echocardiography (STE)]
GLS measured by STE will be compared between children born to mothers with adverse pregnancy outcomes and those born to mothers without adverse pregnancy outcomes, stratifying my maternal SLE status. GLS determined by STE will be measured using a 2-D and 3-D STE software (i.e. TomTec Arena). For evaluation of strain, the endocardial border will be traced, at end-systole in the appropriate imaging plane. Peak GLS will be measured by the software using an average of 2 consecutive cardiac cycles. Measures will be repeated twice to calculate intra-observer intraclass correlation coefficient (ICC). Another blinded investigator will review STE assessments to calculate the inter-observer ICC.
2 years
Maternal autoantibodies and neonatal global longitudinal strain (GLS) in SLE pregnancies
In SLE offspring, the investigators will determine if GLS differs among those exposed to maternal autoantibodies (assessing respectively anti-Ro/La and aPL) versus unexposed offspring. As well, stratification by quartiles of HCQ cord blood levels will be explored.
2 years
Maternal and cord blood hydroxychloroquine (HCQ) levels with maternal and neonatal global longitudinal strain (GLS)
Any relationship between GLS and HCQ in maternal and cord blood (e.g., J-curve relationship) will be assessed.
2 years
Eligibility Criteria
The At the heart of the matter cohort is a prospective cohort of pregnant women with or without SLE with singleton pregnancies recruited at the Montreal General Hospital and the Royal Victoria Hospital in Montreal, QC, since 2022. This cohort has been established to assess maternal and neonatal myocardial strain in SLE and non-SLE pregnant women, as well as myocardial strain in SLE with or without APOs. This cohort will also be used to study the relationship between HCQ and myocardial strain in SLE mothers and offspring.
You may qualify if:
- Followed at participating sites;
- English/French speaking;
- Gestational age up to 17 weeks
- Intrauterine singleton pregnancy;
- Between the ages of 18 and 45 years
You may not qualify if:
- Women with multiple intrauterine or extrauterine pregnancies;
- Women with prior history of placenta-mediated pregnancy complication;
- Women with preexisting cardiovascular disease, hypertension, and non-gestational diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 23, 2022
First Posted
July 11, 2022
Study Start
April 1, 2021
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
August 11, 2022
Record last verified: 2022-08