Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block (NCT04559425) | Clinical Trial Compass
RecruitingNot Applicable
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
United States, Bulgaria, Canada350 participantsStarted 2020-01-01
Plain-language summary
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.
Who can participate
Age range
16 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Positive or pending anti-Ro/La antibody test results at the time of enrollment
Exclusion Criteria:
* AVB associated with major CHD (e.g. left atrial isomerism, cc-TGA)
* AVB with known negative anti-Ro and/or La antibody test result at enrollment
* 1st degree AVB
* Sinus bradycardia with normal 1:1 AV conduction
* Blocked atrial bigeminy (irregular atrial rate with failure of AV conduction of the premature atrial beat)
* Primary delivery for postnatal treatment
* Maternal-fetal conditions (other than cardiac NL) associated with high odds of premature delivery or death (e.g. renal failure, significant infectious diseases, major extracardiac anomalies, PROM, etc.)
* Preexisting maternal mental disorder (e.g. bipolar, mania, severe depression, substance abuse)
* Poorly controlled insulin-dependent diabetes (HbA1c \>7%) at CAVB diagnosis
* Oligohydramnios (deepest/maximal vertical pocket \<2 cm)
* Severe IUGR (estimated fetal weight \<3rd percentile)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.