Dexamethasone for Fetal Heart Block

Recruiting at 28 trial locations

Overseen By Edgar Jaeggi, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Major CHD, Mental disorder, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for pregnant women whose unborn babies have an abnormally slow heart rate due to maternal antibodies affecting the baby's heart. The researchers seek to gather data on current management practices and enhance treatment guidance by creating an international database. The trial involves monitoring pregnancies and may include using dexamethasone, a corticosteroid medication, to help manage the baby's heart condition. Pregnant women diagnosed with a high-degree heart block in their baby at or before 32 weeks, who have tested positive or are awaiting results for specific antibodies, might be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this observational study is safe for pregnant women and their unborn babies?

Research has shown that administering dexamethasone to pregnant mothers can help manage heart issues in their unborn babies. Studies have found that babies receiving this treatment have a low risk of complications such as death around birth and heart muscle disease after birth. These findings suggest that dexamethasone is generally safe, with few serious side effects reported. This provides reassurance about its safety for both mothers and their unborn babies when addressing heart block caused by the mother's antibodies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using dexamethasone for fetal immune-mediated high-degree heart block because it offers a unique approach compared to current treatments. Unlike typical management strategies that often involve observation and post-birth interventions, dexamethasone is a corticosteroid that can cross the placenta and directly reduce inflammation in the fetus. This anti-inflammatory action might help stabilize or improve heart block conditions before birth, offering a proactive option that could potentially prevent complications associated with the condition.

What evidence suggests that this trial's treatments could be effective for managing fetal heart block during pregnancy?

Research has shown that dexamethasone can help treat fetal heart block. In past cases, dexamethasone reduced health problems after birth and lowered death rates. For fetal heart block related to anti-Ro/SSA antibodies, dexamethasone treatment led to better outcomes. Studies also found that recovery rates improved significantly within just a week of using dexamethasone. This trial includes two prospective observational cohorts to study the effects of dexamethasone on different degrees of fetal heart block, suggesting that dexamethasone could effectively manage heart block in unborn babies. ^{2 3 6 7 8}

Who Is on the Research Team?

Edgar Jaeggi, MD

Principal Investigator

The Hospital for Sick Children, Toronto

Are You a Good Fit for This Trial?

Inclusion Criteria

Written informed maternal consent to participate in the Slow Heart Registry

High-degree (2nd; 2:1; 2nd-3rd or 3rd degree) AVB diagnosed ≤ 32+0 weeks with or without hydrops

Enrollment within maximally 8 days of high-degree AVB diagnosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Prenatal Observation

Monitoring of fetal heart block and management decisions based on clinical findings

Up to birth

Regular visits as per clinical need

Postnatal Follow-up

Monitoring of transplant-free survival and clinical evolution from birth to 1-3 years of life

1-3 years

Periodic visits for developmental and cardiac assessments

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

How Is the Trial Designed?

Group I: Prospective observational cohort 2 Experimental Treatment 2 Interventions

Incomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops

Group II: Prospective observational cohort 1 Experimental Treatment 2 Interventions

Complete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35066948/

Steroid Use for Recovery of advanced atrioVentricular ... Conclusion: Dexamethasone may serve as a safe and effective medication to help hasten recovery of advanced AVB after valvular surgery. Keywords: ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/jce.15378

Steroid Use for Recovery of advanced atrioVentricular ... Dexamethasone led to higher recovery rates at Day 5 (82.6% vs. 62.9%, p = .009) and Day 7 (88.4% vs. 61.4%, p < .0001) respectively. This ...

3. ahajournals.org ahajournals.org/doi/10.1161/01.cir.0000142046.58632.3a

Transplacental Fetal Treatment Improves the Outcome of ... At the time of diagnosis of heart block, maternal dexamethasone (4 or 8 mg/d for 2 weeks, followed by 4 mg/d) was initiated and, when possible, maintained for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04474223

Study Details | NCT04474223 | Surveillance and Treatment ... Combining results from studies comprising 275 anti-Ro+ pregnancies, 87% completed monitoring with a false positive rate of 5%. In 4 cases of 2° AVB identified ...

5. childrenscolorado.org childrenscolorado.org/advances-answers/recent-articles/heart-block-dexamethasone/

Dexamethasone Treatment for Anti-Ro/SSA Positive ... A study found dexamethasone treatment for anti-Ro/SSA-mediated fetal heart block decreased neonatal morbidity and overall mortality.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9238501/

Outcome of Antibody‐Mediated Fetal Heart Disease With ... Our findings reveal a low risk of perinatal mortality and postnatal cardiomyopathy in fetuses that received transplacental dexamethasone±other treatment.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35014577/

NAFTNet retrospective report on the treatment of anti-Ro/ ... We hypothesized that dexamethasone treatment for fetal anti-Ro/SSA antibody-mediated cardiac disease leads to better pregnancy outcomes than expectant ...

8. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/uog.1713

Treatment of fetal heart block with maternal steroid therapy ... A PubMed search was performed to obtain all the available data on maternal steroid therapy for the prevention or treatment of fetal heart block.