Actively Recruiting
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
Led by The Hospital for Sick Children · Updated on 2024-05-22
350
Participants Needed
27
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed maternal consent to participate in the Slow Heart Registry
- Diagnosis of high-degree (2nd, 2:1, 2nd-3rd, or 3rd degree) atrio-ventricular heart block at 32 weeks gestation or earlier, with or without hydrops
- Enrollment within 8 days of high-degree heart block diagnosis
- Positive or pending anti-Ro/La antibody test results at enrollment
You will not qualify if you...
- Heart block associated with major congenital heart defects such as left atrial isomerism or cc-TGA
- Negative anti-Ro and/or La antibody test results at enrollment
- 1st degree atrio-ventricular heart block
- Sinus bradycardia with normal 1:1 AV conduction
- Blocked atrial bigeminy
- Planned delivery primarily for postnatal treatment
- Maternal-fetal conditions with high risk of premature delivery or death, including renal failure, significant infections, major extracardiac anomalies, or premature rupture of membranes
- Preexisting maternal mental disorders like bipolar disorder, mania, severe depression, or substance abuse
- Poorly controlled insulin-dependent diabetes (HbA1c over 7%) at diagnosis
- Oligohydramnios with maximum vertical pocket less than 2 cm
- Severe intrauterine growth restriction with estimated fetal weight below the 3rd percentile
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Children's Hospital Colorado
Denver, Colorado, United States, 80205
Actively Recruiting
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
6
Children's Mercy Kansas City
Kansas City, Kansas, United States, 64108
Actively Recruiting
7
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
The Children's Heart Clinic/Children's Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
9
Columbia University (New York)
New York, New York, United States, 10027
Actively Recruiting
10
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
11
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
12
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
13
National Heart Hospital
Sofia, Bulgaria
Actively Recruiting
14
IWK Nova Scotia Health
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
15
The Hospital for Sick Children
Toronto, Canada
Actively Recruiting
16
Hospital District of Helsinki and Uusimaa
Helsinki, Finland, 00260
Actively Recruiting
17
Grenoble University Hospital
Grenoble, France
Actively Recruiting
18
University of Bonn
Bonn, Germany
Actively Recruiting
19
Hong Kong Children's Hospital
Ngau Tau Kok, Hong Kong
Actively Recruiting
20
Kanagawa Children's Medical Center
Kanagawa, Japan
Actively Recruiting
21
Shizuoka Children's Hospital
Shizuoka, Japan
Actively Recruiting
22
Leiden University Medical Center - LUMC
Leiden, Netherlands
Actively Recruiting
23
Centre of Postgraduate Medical Education Poland
Warsaw, Poland
Actively Recruiting
24
Queen Silvia Children's Hospital
Gothenburg, Sweden
Actively Recruiting
25
Skane University Hospital in Lund
Lund, Sweden
Actively Recruiting
26
Karolinska University Hospital, Astrid Lindgen Childrens Hospital
Solna, Sweden
Actively Recruiting
27
Taiji Clinic
Taipei, Taiwan
Actively Recruiting
Research Team
D
Diana Balmer-Minnes, BSc, CCRP
CONTACT
E
Edgar Jaeggi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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