[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04559425":3,"trial-entities:NCT04559425":441,"trial-summary:NCT04559425":447},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":48,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":28,"eligibility_criteria":81,"std_ages":100,"locations":103,"central_contacts":429,"overall_officials":436,"references":439,"see_also_links":440},"NCT04559425","1000065121","Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block","Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block","RECRUITING","2029-12-31","2024-05","2024-05-22","2020-01-01","The Hospital for Sick Children","OTHER",false,"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.","The SLOW HEART REGISTRY is a multi-centered prospective observational study of fetuses diagnosed with high-degree immune-mediated atrio-ventricular heart block (AVB). 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.\n\nThe study aims are to document the outcome of patients diagnosed prenatally with immune-mediated 2nd or 3rd degree AVB irrespective of the primary choice of prenatal care.\n\nThe primary objective will be to determine the rate of transplant-free survival to 1 year of life of fetuses with AVB based on the prenatal management decision:\n\n* Cohort 1: Fetuses not treated with fluorinated glucocorticoids\n* Cohort 2: Fetuses treated with fluorinated glucocorticoids from the time of immune-mediated AVB diagnosis.\n\nSecondary objectives will be to determine:\n\n1. the evolution of clinical findings from AVB diagnosis to birth (AV conduction; fetal heart rate; other NL manifestations; fetal growth; effusions\u002Fhydrops) between cohorts;\n2. the need of new\u002Fadditional treatment (steroids; beta-mimetics; IVIG) to birth;\n3. gestational age and weight at birth;\n4. postnatal management (pacing; steroids; IVIG); and\n5. clinical evolution from birth to 1-3 years of life (cardiac function; developmental milestones; infant growth; health).\n\nPrevalence of relevant fetal-maternal events and complications (death; IUGR; morbidity) between the study cohorts will also be determined.\n\nAll management is decided by the treating center and physicians in accordance to institutional guidelines and clinical findings. Patient enrollment in the SLOW HEART REGISTRY is possible within up to 8 days of the initial management decision.\n\nParticipation in this prospective observational cohort study requires site REB approval and an executed legal contract with the primary investigator\u002FSickKids Hospital, Toronto.",[19,20],"Heart Block Complete","Heart Block Second Degree",[22,23,24,25,26],"fetal","heart block","anti-Ro antibodies","steroids","outcome","OBSERVATIONAL",null,[],{"count":31,"type":32},350,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Dexamethasone","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",[39,40],"Prospective observational cohort 1","Prospective observational cohort 2",{"type":14,"name":42,"description":37,"armGroupLabels":43},"No Dexamethasone",[39,40],[45],{"measure":46,"timeFrame":47},"Freedom from cardiac death ≥1 year of life","up to 12 months",[49,52,55,57,59,62,64,67,69,72,75],{"measure":50,"timeFrame":51},"Proportion of participants with fetal and neonatal death and their causes\u002Ffactors","1 month",{"measure":53,"timeFrame":54},"Proportion of participants with change in prenatal treatment","up to 6 months",{"measure":56,"timeFrame":54},"Proportion of secondarily treated patients (initially untreated group 1 cases)",{"measure":58,"timeFrame":54},"Proportion of serious pregnancy outcomes (IUFD, IUGR \u003C3rd percentile, delivery \u003C35 weeks)",{"measure":60,"timeFrame":61},"Proportion of patients\u002Fgroup with progression from incomplete to complete AVB by 1 year","Fetal diagnosis to 12 months",{"measure":63,"timeFrame":61},"Proportion of maternal serious adverse events and outcomes",{"measure":65,"timeFrame":66},"Average gestational age at birth","Birth",{"measure":68,"timeFrame":66},"Average birth weight",{"measure":70,"timeFrame":71},"Freedom from permanent pacemaker implantation from birth to 1 year of life","Birth to 12 months",{"measure":73,"timeFrame":74},"Prevalence of significant heart failure (HF score, echo, HF treatment) at 1 year of life","12 months",{"measure":76,"timeFrame":77},"Proportion of children with moderate\u002Fsevere neuro-developmental delay at 12-18 months","12-18 months","FEMALE","16 Years","50 Years",{"inclusion":82,"exclusion":87,"raw_text":99},[83,84,85,86],"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\u002FLa antibody test results at the time of enrollment",[88,89,90,91,92,93,94,95,96,97,98],"AVB associated with major CHD (e.g. left atrial isomerism, cc-TGA)","AVB with known negative anti-Ro and\u002For 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\u002Fmaximal vertical pocket \\\u003C2 cm)","Severe IUGR (estimated fetal weight \\\u003C3rd percentile)","Inclusion Criteria:\n\n* Written informed maternal consent to participate in the Slow Heart Registry\n* High-degree (2nd; 2:1; 2nd-3rd or 3rd degree) AVB diagnosed ≤ 32+0 weeks with or without hydrops\n* Enrollment within maximally 8 days of high-degree AVB diagnosis\n* Positive or pending anti-Ro\u002FLa antibody test results at the time of enrollment\n\nExclusion Criteria:\n\n* AVB associated with major CHD (e.g. left atrial isomerism, cc-TGA)\n* AVB with known negative anti-Ro and\u002For La antibody test result at enrollment\n* 1st degree AVB\n* Sinus bradycardia with normal 1:1 AV conduction\n* Blocked atrial bigeminy (irregular atrial rate with failure of AV conduction of the premature atrial beat)\n* Primary delivery for postnatal treatment\n* 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.)\n* Preexisting maternal mental disorder (e.g. bipolar, mania, severe depression, substance abuse)\n* Poorly controlled insulin-dependent diabetes (HbA1c \\>7%) at CAVB diagnosis\n* Oligohydramnios (deepest\u002Fmaximal vertical pocket \\\u003C2 cm)\n* Severe IUGR (estimated fetal weight \\\u003C3rd percentile)",[101,102],"CHILD","ADULT",[104,119,132,144,157,168,181,192,205,217,230,242,259,271,285,299,310,322,332,344,356,367,377,389,399,409,418],{"facility":105,"status":8,"city":106,"state":107,"zip":108,"country":109,"contacts":110,"geoPoint":116},"Phoenix Children's Hospital","Phoenix","Arizona","85016","United States",[111],{"name":112,"role":113,"phone":114,"email":115},"Neda Mulla, MD","CONTACT","602-933-1000","nmulla@phoenixchildrens.com",{"lat":117,"lon":118},33.44838,-112.07404,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":109,"contacts":124,"geoPoint":129},"University of California San Francisco","San Francisco","California","94143",[125],{"name":126,"role":113,"phone":127,"email":128},"Anita J Moon-Grady, MD","415-342-8836","anita.grady@ucsf.edu",{"lat":130,"lon":131},37.77493,-122.41942,{"facility":133,"status":8,"city":134,"state":135,"zip":136,"country":109,"contacts":137,"geoPoint":141},"Children's Hospital Colorado","Denver","Colorado","80205",[138],{"name":139,"role":113,"email":140},"Karrie Villavicencio, MD","karrie.villavicencio@childrenscolorado.org",{"lat":142,"lon":143},39.73915,-104.9847,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":109,"contacts":149,"geoPoint":154},"Children's National Medical Center","Washington D.C.","District of Columbia","20010",[150,152],{"name":151,"role":113},"Mary Donofrio, MD",{"name":151,"role":153},"PRINCIPAL_INVESTIGATOR",{"lat":155,"lon":156},38.89511,-77.03637,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":109,"contacts":162,"geoPoint":165},"Johns Hopkins All Children's Hospital","St. Petersburg","Florida","33701",[163],{"name":164,"role":113},"Grace Freire",{"lat":166,"lon":167},27.77086,-82.67927,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":109,"contacts":173,"geoPoint":178},"Children's Mercy Kansas City","Kansas City","Kansas","64108",[174],{"name":175,"role":113,"phone":176,"email":177},"Nitin Madan, MD","816-302-3673","nmadan@cmh.edu",{"lat":179,"lon":180},39.11417,-94.62746,{"facility":182,"status":8,"city":183,"state":184,"zip":185,"country":109,"contacts":186,"geoPoint":189},"Boston Children's Hospital","Boston","Massachusetts","02115",[187],{"name":188,"role":113},"Audrey Dionne",{"lat":190,"lon":191},42.35843,-71.05977,{"facility":193,"status":8,"city":194,"state":195,"zip":196,"country":109,"contacts":197,"geoPoint":202},"The Children's Heart Clinic\u002FChildren's Minnesota","Minneapolis","Minnesota","55404",[198],{"name":199,"role":113,"phone":200,"email":201},"Lisa Lisa, MD","612-964-6344","lhowley@chc-pa.org",{"lat":203,"lon":204},44.97997,-93.26384,{"facility":206,"status":8,"city":207,"state":207,"zip":208,"country":109,"contacts":209,"geoPoint":214},"Columbia University (New York)","New York","10027",[210],{"name":211,"role":113,"phone":212,"email":213},"Stéphanie Levasseur, MD, FRCPC","212-305-8356","sl2363@cumc.columbia.edu",{"lat":215,"lon":216},40.71427,-74.00597,{"facility":218,"status":8,"city":219,"state":220,"zip":221,"country":109,"contacts":222,"geoPoint":227},"Texas Children's Hospital","Houston","Texas","77030",[223],{"name":224,"role":113,"phone":225,"email":226},"Shaine A Morris,, MD, MPH","832-826-5682","shainem@bcm.edu",{"lat":228,"lon":229},29.76328,-95.36327,{"facility":231,"status":8,"city":232,"state":233,"zip":234,"country":109,"contacts":235,"geoPoint":239},"Seattle Children's Hospital","Seattle","Washington","98105",[236],{"name":237,"role":113,"email":238},"Nelangi Pinto, MD","nelangi.pinto@seattlechildrens.org",{"lat":240,"lon":241},47.60621,-122.33207,{"facility":243,"status":8,"city":244,"state":245,"zip":246,"country":109,"contacts":247,"geoPoint":256},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",[248,252],{"name":249,"role":113,"phone":250,"email":251},"Janette Stasburger, MD","414-805-6605","jstrasburger@chw.org",{"name":253,"role":113,"phone":254,"email":255},"Eleanor Saffian, RNC-OB","(414)805-6605","esaffian@mcw.edu",{"lat":257,"lon":258},43.0389,-87.90647,{"facility":260,"status":8,"city":261,"country":262,"contacts":263,"geoPoint":268},"National Heart Hospital","Sofia","Bulgaria",[264],{"name":265,"role":113,"phone":266,"email":267},"Zornitsa Vassileva, MD","+359 2 921 1211","zornitsa.vassileva@markovs.bg",{"lat":269,"lon":270},42.69751,23.32415,{"facility":272,"status":8,"city":273,"state":274,"zip":275,"country":276,"contacts":277,"geoPoint":282},"IWK Nova Scotia Health","Halifax","Nova Scotia","B3K 6R8","Canada",[278],{"name":279,"role":113,"phone":280,"email":281},"Santokh Dhillon,, MD","(902) 470-8888","Santokh.Dhillon@iwk.nshealth.ca",{"lat":283,"lon":284},44.64269,-63.57688,{"facility":13,"status":8,"city":286,"country":276,"contacts":287,"geoPoint":296},"Toronto",[288,292,295],{"name":289,"role":113,"phone":290,"email":291},"Edgar Jaeggi, MD","416-813-7500","edgar.jaeggi@sickkids.ca",{"name":293,"role":113,"phone":290,"email":294},"Diana Balmer-Minnes, M.Sc","slow.heart@sickkids.ca",{"name":289,"role":153},{"lat":297,"lon":298},43.70643,-79.39864,{"facility":300,"status":8,"city":301,"zip":302,"country":303,"contacts":304,"geoPoint":307},"Hospital District of Helsinki and Uusimaa","Helsinki","00260","Finland",[305],{"name":306,"role":113},"Taisto Sarkola",{"lat":308,"lon":309},60.16952,24.93545,{"facility":311,"status":8,"city":312,"country":313,"contacts":314,"geoPoint":319},"Grenoble University Hospital","Grenoble","France",[315],{"name":316,"role":113,"phone":317,"email":318},"Matthias Lachaud, MD","+33 (0)4 76 76 94 95","mlachaud@chu-grenoble.fr",{"lat":320,"lon":321},45.17869,5.71479,{"facility":323,"status":8,"city":324,"country":325,"contacts":326,"geoPoint":329},"University of Bonn","Bonn","Germany",[327],{"name":328,"role":113},"Ulrike Herberg",{"lat":330,"lon":331},50.73438,7.09549,{"facility":333,"status":8,"city":334,"country":335,"contacts":336,"geoPoint":341},"Hong Kong Children's Hospital","Ngau Tau Kok","Hong Kong",[337],{"name":338,"role":113,"phone":339,"email":340},"Pak-Cheong Chow, MD","+852 3513 3888","chowpc@ha.org.hk",{"lat":342,"lon":343},22.32695,114.21709,{"facility":345,"status":8,"city":346,"country":347,"contacts":348,"geoPoint":353},"Kanagawa Children's Medical Center","Kanagawa","Japan",[349],{"name":350,"role":113,"phone":351,"email":352},"Ki-Sung Kim, MD","+81 45-711-2351","kskim9399@gmail.com",{"lat":354,"lon":355},37.58333,139.91667,{"facility":357,"status":8,"city":358,"country":347,"contacts":359,"geoPoint":364},"Shizuoka Children's Hospital","Shizuoka",[360],{"name":361,"role":113,"phone":362,"email":363},"Masaki Nii, MD, PhD","81-54-247-6251","nii3mysy@gmail.com",{"lat":365,"lon":366},34.98333,138.38333,{"facility":368,"status":8,"city":369,"country":370,"contacts":371,"geoPoint":374},"Leiden University Medical Center - LUMC","Leiden","Netherlands",[372],{"name":373,"role":153},"Nico Blom, MD",{"lat":375,"lon":376},52.15833,4.49306,{"facility":378,"status":8,"city":379,"country":380,"contacts":381,"geoPoint":386},"Centre of Postgraduate Medical Education Poland","Warsaw","Poland",[382],{"name":383,"role":113,"phone":384,"email":385},"Joanna Dangel, MD","22 51 02 608","jdangel@cmkp.edu.pl",{"lat":387,"lon":388},52.22977,21.01178,{"facility":390,"status":8,"city":391,"country":392,"contacts":393,"geoPoint":396},"Queen Silvia Children's Hospital","Gothenburg","Sweden",[394],{"name":395,"role":113},"Annika Ohman",{"lat":397,"lon":398},57.70716,11.96679,{"facility":400,"status":8,"city":401,"country":392,"contacts":402,"geoPoint":406},"Skane University Hospital in Lund","Lund",[403],{"name":404,"role":113,"email":405},"Misha Bhat, MD","misha.bhat@skane.se",{"lat":407,"lon":408},55.70584,13.19321,{"facility":410,"status":8,"city":411,"country":392,"contacts":412,"geoPoint":415},"Karolinska University Hospital, Astrid Lindgen Childrens Hospital","Solna",[413],{"name":414,"role":113},"Hakan Eliasson",{"lat":416,"lon":417},59.36004,18.00086,{"facility":419,"status":8,"city":420,"country":421,"contacts":422,"geoPoint":426},"Taiji Clinic","Taipei","Taiwan",[423],{"name":424,"role":113,"email":425},"Wangling Chih, MD","wanling.chih@fetalmedicine.tw",{"lat":427,"lon":428},25.05306,121.52639,[430,434],{"name":431,"role":113,"phone":432,"phoneExt":433,"email":294},"Diana Balmer-Minnes, BSc, CCRP","416-813-7654","228624",{"name":289,"role":113,"phone":435,"email":294},"418-813-7466",[437],{"name":289,"affiliation":438,"role":153},"The Hospital for Sick Children, Toronto",[],[],{"nct_id":4,"conditions":442,"biomarkers":444},[443],"Heart block",[445,446],"anti-Ro","Blood group antibody A>1\u003C",{"nct_id":4,"found":448,"summary":449,"prompt_version":459},true,{"design":450,"status":451,"heading":452,"summary":453,"follow_up":454,"word_count":455,"commitments":456,"compensation":457,"drugs_mentioned":458},"This is an observational study, meaning researchers will collect information without giving specific treatments. It aims to enroll 350 participants.","completed","Slow Heart Registry for Fetal Immune-mediated High Degree Heart Block","This study is creating a registry to learn more about how to best care for unborn babies (fetuses) who have a very slow heartbeat, called high-degree heart block. This condition is caused by the mother's immune system. Doctors currently make treatment decisions without clear evidence from studies. This registry will collect information on how these pregnancies are managed and what happens to the babies. The study is looking at two groups: those whose mothers receive Dexamethasone (a medication) and those who do not. The main goal is to see how many babies survive for at least one year without needing a heart transplant. You may be able to join if you are a woman between 16 and 50 years old, have a fetus diagnosed with high-degree heart block before 32 weeks of pregnancy, and have certain antibodies (anti-Ro\u002FLa).","Participants will be followed for at least one year after the baby's birth to assess survival.",138,"Not specified in the trial record.","Not stated in the trial record.",[36],"v2"]