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NCT05451277
At the Heart of the Matter - Speckle Tracking Echocardiography in Lupus Mothers and Their Offspring
trial in Systemic Lupus Erythematosus in 120 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | Evelyne Vinet |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 1 April 2021 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 September 2023 |
| Sites | 1 location across Canada |
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
- Placenta-mediated Pregnancy Complications — all drugs for Placenta-mediated Pregnancy Complications →
- Hydroxychloroquine — all drugs for Hydroxychloroquine →
- Speckle Tracking Echocardiography — all drugs for Speckle Tracking Echocardiography →
Sponsor
Evelyne Vinet
Who can join
Adults 18 to 45, female only, with Systemic Lupus Erythematosus or Placenta-mediated Pregnancy Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05451277 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Evelyne Vinet
- Last refreshed: 11 August 2022
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