Heart Block Complete Clinical Trial
Official title:
Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block
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.
| Status | Recruiting |
| Enrollment | 350 |
| Est. completion date | December 31, 2029 |
| Est. primary completion date | December 31, 2027 |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 16 Years to 50 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | National Heart Hospital | Sofia | |
| Canada | IWK Nova Scotia Health | Halifax | Nova Scotia |
| Canada | The Hospital for Sick Children | Toronto | |
| Finland | Hospital District of Helsinki and Uusimaa | Helsinki | |
| France | Grenoble University Hospital | Grenoble | |
| Germany | University of Bonn | Bonn | |
| Hong Kong | Hong Kong Children's Hospital | Ngau Tau Kok | |
| Japan | Kanagawa Children's Medical Center | Kanagawa | |
| Japan | Shizuoka Children's Hospital | Shizuoka | |
| Netherlands | Leiden University Medical Center - LUMC | Leiden | |
| Poland | Centre of Postgraduate Medical Education Poland | Warsaw | |
| Sweden | Queen Silvia Children's Hospital | Gothenburg | |
| Sweden | Skane University Hospital in Lund | Lund | |
| Sweden | Karolinska University Hospital, Astrid Lindgen Childrens Hospital | Solna | |
| Taiwan | Taiji Clinic | Taipei | |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | Children's Hospital Colorado | Denver | Colorado |
| United States | Texas Children's Hospital | Houston | Texas |
| United States | Children's Mercy Kansas City | Kansas City | Kansas |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | The Children's Heart Clinic/Children's Minnesota | Minneapolis | Minnesota |
| United States | Columbia University (New York) | New York | New York |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
| United States | University of California San Francisco | San Francisco | California |
| United States | Seattle Children's Hospital | Seattle | Washington |
| United States | Children's National Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children |
United States, Bulgaria, Canada, Finland, France, Germany, Hong Kong, Japan, Netherlands, Poland, Sweden, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Freedom from cardiac death =1 year of life | up to 12 months | ||
| Secondary | Proportion of participants with fetal and neonatal death and their causes/factors | 1 month | ||
| Secondary | Proportion of participants with change in prenatal treatment | up to 6 months | ||
| Secondary | Proportion of secondarily treated patients (initially untreated group 1 cases) | up to 6 months | ||
| Secondary | Proportion of serious pregnancy outcomes (IUFD, IUGR <3rd percentile, delivery <35 weeks) | up to 6 months | ||
| Secondary | Proportion of patients/group with progression from incomplete to complete AVB by 1 year | Fetal diagnosis to 12 months | ||
| Secondary | Proportion of maternal serious adverse events and outcomes | Fetal diagnosis to 12 months | ||
| Secondary | Average gestational age at birth | Birth | ||
| Secondary | Average birth weight | Birth | ||
| Secondary | Freedom from permanent pacemaker implantation from birth to 1 year of life | Birth to 12 months | ||
| Secondary | Prevalence of significant heart failure (HF score, echo, HF treatment) at 1 year of life | 12 months | ||
| Secondary | Proportion of children with moderate/severe neuro-developmental delay at 12-18 months | 12-18 months |