Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block

Conditions

• Heart Block Complete
• Heart Block Second Degree

Eligibility Criteria

Sex

FEMALE

Age

16 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Dexamethasone — DRUG
  All management decisions are made by the primary physician and may include: 1) no treatment with dexamethasone or 2) treatment with dexamethasone from the time of enrollment
• No Dexamethasone — OTHER
  All management decisions are made by the primary physician and may include: 1) no treatment with dexamethasone or 2) treatment with dexamethasone from the time of enrollment

Study Details

Few studies are specifically designed to address health concerns that are already relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.

Key Dates

Start date

Jan 1, 2020

Status verified

May 2024

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

350 participants (estimated)

Arms

• Arm: Prospective observational cohort 1
  Complete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
• Arm: Prospective observational cohort 2
  Incomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops

Primary Outcome Measure

Freedom from cardiac death ≥1 year of life [ Time Frame: up to 12 months ]

Central Contacts

• Diana Balmer-Minnes, BSc, CCRP
  416-813-7654
  [email protected]
• Edgar Jaeggi, MD
  418-813-7466
  [email protected]

Locations (12)

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