Cohort Description of Younger With AV-block

NCT03024047 | Unknown DMC

• 1 other identifier: DAN-BLOCK_Study1
• Study Type: observational
• Target: 1,255
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Disturbances of the heart's atrioventricular conduction - AV-block - may show by shortness of breath, fainting or sudden death. If AV-block is diagnosed in time pacemaker therapy may be lifesaving. AV-block in younger can be seen along with structural or ischemic heart disease, congenital heart disease (incl. congenital AV-block) storage disorders, specific muscle diseases, sarcoidosis, Borrelia infection or drug intoxication. AV-block in younger can also be seen in conditions, primarily localized to the AV-node without other cardiac disease at diagnosis. This form of AV-block is often hereditary and can be seen in families where relatives have another types of heart disease in form of fore example, cardiomyopathy, ion channel disease or sudden death. The different forms of presentation are due to the same gene mutation being expressed differently within the same family. Thus, early onset of AV-block (\<50 years) may indicate hereditary AV-conduction disorder but it can also be the first manifestation of severe ion channel disease or cardiomyopathy. Denmark has annually over 50 individuals \<50 years treated with pacemaker due to advanced AV-block. There have been no overall figures regarding the causes of advanced AV-block, and therefore no systematic approach to diagnosing this group of patients. Furthermore, the prevalence of individuals with a genetic cause of AV-block is unknown and presumably an often overlooked diagnosis among younger patients with advanced AV-blok. There are no data on disease progression after diagnosis, and therefore there is no evidence-based knowledge about how these patients should be followed after diagnosis. With modern gene technology, a range of new, yet unknown genes with potentially pathogenic mutations is likely to be identified. Identification of such genes, and the development of a strategy for systematic approach to diagnose younger patients with AV-block, will enable presymptomatic genetic screening of relatives and implementation of evidence-based, preventive treatment with pacemaker and/or medical treatment for heart failure based on a specific genetic predisposition for development of AV-block with or without heart failure. Hypotheses: In a significant proportion of younger patients with advanced AV-block the underlying cause is unknown. Objective: To investigate the prevalence and causes of advanced AV-block in younger patients in Denmark and describe the current diagnostics. Method: The study is a cross sectional study. The patients for this study are identified from Danish Pacemaker and ICD Register. The investigators will review medical records and obtain clinical information and test results (see detailed description). Perspectives: This study is the first part of a large study of AV-block in younger patients in Denmark. The overall goal, is to increase knowledge about the causes of and disease progression after the diagnosis of advanced AV-block in young patients which could lead to a significant improvement in the treatment of this patient group and may lead to a customized choice of pacemaker type in the future and perhaps additional medical treatment in this patient group. This could potentially lead to a reduction in both their morbidity mortality.

Conditions

Atrioventricular Block; Progressive Cardiac Conduction Defect; Genetic Disease

Outcome Measures

Primary Outcomes (12)

• Prevalence of structural heart disease as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of ischemic heart disease as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of congenital heart disease as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of congenital AV-block

  01.01.1996 - 31.12.2015

• Prevalence of muscular dystrophy as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of sarcoidosis as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of lyme disease as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of genetic cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of complications to operation as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of complications to radio frequency ablation as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of endocarditis as cause of AV-block

  01.01.1996 - 31.12.2015

• Prevalence of unknown cause of AV-block

  01.01.1996 - 31.12.2015

Interventions

Pacemaker DEVICE

Eligibility Criteria

• Age: Up to 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All patients in Denmark with AV-block who were treated with pacemaker for the first time between 01.01.1996 - 31.12.2015 with age at implantation \<50 years will be included in the study (n=1,255 patients).

You may qualify if:

• All patients in Denmark
• Treated with pacemaker due to AV-block
• Implanted for the first time between 01.01.1996 - 31.12.2015
• Age at implantation \<50 years

You may not qualify if:

• Non

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of cardiology, Research, Aarhus University Hospital, Denmark

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Atrioventricular Block; Bundle-Branch Block; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Johnni T. R. Dideriksen, M.D.

CONTACT

0045 40832508; johndide@rm.dk

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 18, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2018
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

DK (1)