Recruiting

Hydroxychloroquine

Sponsor:

Evelyne Vinet

Code:

NCT05451277

Conditions

Systemic Lupus Erythematosus

Placenta-mediated Pregnancy Complications

Hydroxychloroquine

Speckle Tracking Echocardiography

Cardiovascular Morbidity

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Systemic Lupus Erythematosus

Placenta-mediated Pregnancy Complications

Hydroxychloroquine

Speckle Tracking Echocardiography

Cardiovascular Morbidity

Study ID

NCT05451277

Start date

Apr 1, 2021

Status verified date

Aug, 2022

Completion date

Sep 30, 2023

Anticipated

Primary completion date

Sep 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Followed at participating sites;
  • English/French speaking;
  • Gestational age up to 17 weeks
  • Intrauterine singleton pregnancy;
  • Between the ages of 18 and 45 years

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Maternal cardiac function [i.e., global longitudinal (myocardial) strain (GLS) measured by speckle tracking echocardiography (STE)] [ Time Frame: 2 years ]
  • Neonatal cardiac function [i.e., global longitudinal (myocardial) strain (GLS) measured by speckle tracking echocardiography (STE)] [ Time Frame: 2 years ]
  • Maternal autoantibodies and neonatal global longitudinal strain (GLS) in SLE pregnancies [ Time Frame: 2 years ]
  • Maternal and cord blood hydroxychloroquine (HCQ) levels with maternal and neonatal global longitudinal strain (GLS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

More Information

Sponsor

Evelyne Vinet

Last update posted

Aug 11, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Evelyne Vinet on 2022-08-11.