Heart Block CompleteNCT04559425
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
An observational study of Heart Block Complete and Heart Block Second Degree, run by The Hospital for Sick Children at 27 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Heart Block Complete, Heart Block Second Degree
- What is being tested?
- Dexamethasone and No Dexamethasone
- How many people
- 350 participants
- Where
- 27 sitesin 12 countries
- Study dates
- 1 Jan 2020to 31 Dec 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Child, Adult
Study population: Enrollment into the SLOW HEART Registry is possible within maximally 8 days of the fetal heart block diagnosis and a management decision to treat or not to treat. If a mother elects participation in the Registry, her treating physician will continue to provide care in accordance with clinical practice at the site and will decide all therapy including close observation without or with immediate steroid treatment.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
27 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 12 countries
United States12 sites, 12 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Audrey Dionne
- Recruiting
Children's Hospital Colorado
Denver, Colorado, 80205
Karrie Villavicencio, MD, karrie.villavicencio@childrenscolorado.org
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Shaine A Morris,, MD, MPH, 832-826-5682, shainem@bcm.edu
- Recruiting
Children's Mercy Kansas City
Kansas City, Kansas, 64108
Nitin Madan, MD, 816-302-3673, nmadan@cmh.edu
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Janette Stasburger, MD, 414-805-6605, jstrasburger@chw.org
Eleanor Saffian, RNC-OB, (414)805-6605, esaffian@mcw.edu
- Recruiting
The Children's Heart Clinic/Children's Minnesota
Minneapolis, Minnesota, 55404
Lisa Lisa, MD, 612-964-6344, lhowley@chc-pa.org
- Recruiting
Columbia University (New York)
New York, New York, 10027
Stéphanie Levasseur, MD, FRCPC, 212-305-8356, sl2363@cumc.columbia.edu
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Neda Mulla, MD, 602-933-1000, nmulla@phoenixchildrens.com
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Anita J Moon-Grady, MD, 415-342-8836, anita.grady@ucsf.edu
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Nelangi Pinto, MD, nelangi.pinto@seattlechildrens.org
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Grace Freire
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Mary Donofrio, MD
Mary Donofrio, MD
Sweden3 sites, 3 recruiting
- Recruiting
Queen Silvia Children's Hospital
Gothenburg
Annika Ohman
- Recruiting
Skane University Hospital in Lund
Lund
Misha Bhat, MD, misha.bhat@skane.se
- Recruiting
Karolinska University Hospital, Astrid Lindgen Childrens Hospital
Solna
Hakan Eliasson
Canada2 sites, 2 recruiting
- Recruiting
IWK Nova Scotia Health
Halifax, Nova Scotia, B3K 6R8
Santokh Dhillon,, MD, (902) 470-8888, Santokh.Dhillon@iwk.nshealth.ca
- Recruiting
The Hospital for Sick Children
Toronto
Edgar Jaeggi, MD, 416-813-7500, edgar.jaeggi@sickkids.ca
Diana Balmer-Minnes, M.Sc, 416-813-7500, slow.heart@sickkids.ca
Japan2 sites, 2 recruiting
- Recruiting
Kanagawa Children's Medical Center
Kanagawa
Ki-Sung Kim, MD, +81 45-711-2351, kskim9399@gmail.com
- Recruiting
Shizuoka Children's Hospital
Shizuoka
Masaki Nii, MD, PhD, 81-54-247-6251, nii3mysy@gmail.com
Bulgaria1 site, 1 recruiting
- Recruiting
National Heart Hospital
Sofia
Zornitsa Vassileva, MD, +359 2 921 1211, zornitsa.vassileva@markovs.bg
Finland1 site, 1 recruiting
- Recruiting
Hospital District of Helsinki and Uusimaa
Helsinki, 00260
Taisto Sarkola
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble
Matthias Lachaud, MD, +33 (0)4 76 76 94 95, mlachaud@chu-grenoble.fr
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital
Ngau Tau Kok
Pak-Cheong Chow, MD, +852 3513 3888, chowpc@ha.org.hk
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center - LUMC
Leiden
Nico Blom, MD
Poland1 site, 1 recruiting
- Recruiting
Centre of Postgraduate Medical Education Poland
Warsaw
Joanna Dangel, MD, 22 51 02 608, jdangel@cmkp.edu.pl
Taiwan1 site, 1 recruiting
- Recruiting
Taiji Clinic
Taipei
Wangling Chih, MD, wanling.chih@fetalmedicine.tw
About this study
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.
Read the detailed description
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.
The 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.
The 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:
- Cohort 1: Fetuses not treated with fluorinated glucocorticoids
- Cohort 2: Fetuses treated with fluorinated glucocorticoids from the time of immune-mediated AVB diagnosis.
Secondary objectives will be to determine:
- the evolution of clinical findings from AVB diagnosis to birth (AV conduction; fetal heart rate; other NL manifestations; fetal growth; effusions/hydrops) between cohorts;
- the need of new/additional treatment (steroids; beta-mimetics; IVIG) to birth;
- gestational age and weight at birth;
- postnatal management (pacing; steroids; IVIG); and
- clinical evolution from birth to 1-3 years of life (cardiac function; developmental milestones; infant growth; health).
Prevalence of relevant fetal-maternal events and complications (death; IUGR; morbidity) between the study cohorts will also be determined.
All 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.
Participation in this prospective observational cohort study requires site REB approval and an executed legal contract with the primary investigator/SickKids Hospital, Toronto.
- Conditions
- Heart Block Complete, Heart Block Second Degree
- Being tested
- Dexamethasone, No Dexamethasone
- Keywords
- fetal, heart block, anti-Ro antibodies, steroids, outcome
- Medical subject headings
- Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
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 DexamethasoneOther
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 group | Role | What they receive |
|---|---|---|
| Prospective observational cohort 1 | Complete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops Receives: Drug: Dexamethasone; Other: No Dexamethasone | |
| Prospective observational cohort 2 | Incomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops Receives: Drug: Dexamethasone; Other: No Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from cardiac death ≥1 year of life
Measured: up to 12 months
Secondary outcomes (11)
Proportion of participants with fetal and neonatal death and their causes/factors
Measured: 1 month
Proportion of participants with change in prenatal treatment
Measured: up to 6 months
Proportion of secondarily treated patients (initially untreated group 1 cases)
Measured: up to 6 months
Proportion of serious pregnancy outcomes (IUFD, IUGR <3rd percentile, delivery <35 weeks)
Measured: up to 6 months
Proportion of patients/group with progression from incomplete to complete AVB by 1 year
Measured: Fetal diagnosis to 12 months
Proportion of maternal serious adverse events and outcomes
Measured: Fetal diagnosis to 12 months
Average gestational age at birth
Measured: Birth
Average birth weight
Measured: Birth
Freedom from permanent pacemaker implantation from birth to 1 year of life
Measured: Birth to 12 months
Prevalence of significant heart failure (HF score, echo, HF treatment) at 1 year of life
Measured: 12 months
Proportion of children with moderate/severe neuro-developmental delay at 12-18 months
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Block CompleteStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edgar Jaeggi, The Hospital for Sick Children
- Investigators
- Edgar Jaeggi, MD, Principal investigator, The Hospital for Sick Children, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559425
- Sponsor's protocol ID
- 1000065121
- Status last verified
- May 2024
- First submitted
- 11 Sep 2020
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block
- ClinicalTrials.gov ID
- NCT04559425
- Acronym / sponsor ID
- 1000065121
- Conditions
- Heart Block Complete, Heart Block Second Degree
- Keywords
- fetal, heart block, anti-Ro antibodies, steroids, outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The 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.
The 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:
- Cohort 1: Fetuses not treated with fluorinated glucocorticoids
- Cohort 2: Fetuses treated with fluorinated glucocorticoids from the time of immune-mediated AVB diagnosis.
Secondary objectives will be to determine:
- the evolution of clinical findings from AVB diagnosis to birth (AV conduction; fetal heart rate; other NL manifestations; fetal growth; effusions/hydrops) between cohorts;
- the need of new/additional treatment (steroids; beta-mimetics; IVIG) to birth;
- gestational age and weight at birth;
- postnatal management (pacing; steroids; IVIG); and
- clinical evolution from birth to 1-3 years of life (cardiac function; developmental milestones; infant growth; health).
Prevalence of relevant fetal-maternal events and complications (death; IUGR; morbidity) between the study cohorts will also be determined.
All 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.
Participation in this prospective observational cohort study requires site REB approval and an executed legal contract with the primary investigator/SickKids Hospital, Toronto.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective observational cohort 1 | – | Drug: Dexamethasone, Other: No DexamethasoneComplete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops |
| Prospective observational cohort 2 | – | Drug: Dexamethasone, Other: No DexamethasoneIncomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Enrollment into the SLOW HEART Registry is possible within maximally 8 days of the fetal heart block diagnosis and a management decision to treat or not to treat. If a mother elects participation in the Registry, her treating physician will continue to provide care in accordance with clinical practice at the site and will decide all therapy including close observation without or with immediate steroid treatment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAll 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 | Drug | Prospective observational cohort 1, Prospective observational cohort 2 |
| No DexamethasoneAll 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 | Other | Prospective observational cohort 1, Prospective observational cohort 2 |
Primary outcome
Freedom from cardiac death ≥1 year of life
Time frame: up to 12 months
11 secondary outcomes
Proportion of participants with fetal and neonatal death and their causes/factors
Time frame: 1 month
Proportion of participants with change in prenatal treatment
Time frame: up to 6 months
Proportion of secondarily treated patients (initially untreated group 1 cases)
Time frame: up to 6 months
Proportion of serious pregnancy outcomes (IUFD, IUGR <3rd percentile, delivery <35 weeks)
Time frame: up to 6 months
Proportion of patients/group with progression from incomplete to complete AVB by 1 year
Time frame: Fetal diagnosis to 12 months
Proportion of maternal serious adverse events and outcomes
Time frame: Fetal diagnosis to 12 months
Average gestational age at birth
Time frame: Birth
Average birth weight
Time frame: Birth
Freedom from permanent pacemaker implantation from birth to 1 year of life
Time frame: Birth to 12 months
Prevalence of significant heart failure (HF score, echo, HF treatment) at 1 year of life
Time frame: 12 months
Proportion of children with moderate/severe neuro-developmental delay at 12-18 months
Time frame: 12-18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edgar Jaeggi, MD principal investigator
The Hospital for Sick Children, Toronto
27 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Block Complete and Heart Block Second Degree, run by The Hospital for Sick Children at 27 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Sweden, Canada, Japan, Bulgaria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Balmer-Minnes, BSc, CCRP (416-813-7654 ext. 228624, slow.heart@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from cardiac death ≥1 year of life (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.