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Cohort Description of Younger With AV-block

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ClinicalTrials.gov Identifier: NCT03024047
Recruitment Status : Unknown
Verified January 2017 by University of Aarhus.
Recruitment status was:  Not yet recruiting
First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment
Atrioventricular Block Progressive Cardiac Conduction Defect Genetic Disease Device: Pacemaker

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1255 participants
Time Perspective: Retrospective
Study Start Date : January 2017
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of structural heart disease as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  2. Prevalence of ischemic heart disease as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  3. Prevalence of congenital heart disease as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  4. Prevalence of congenital AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  5. Prevalence of muscular dystrophy as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  6. Prevalence of sarcoidosis as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  7. Prevalence of lyme disease as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  8. Prevalence of genetic cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  9. Prevalence of complications to operation as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  10. Prevalence of complications to radio frequency ablation as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  11. Prevalence of endocarditis as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  12. Prevalence of unknown cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]


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Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024047


Contacts
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Contact: Johnni T. R. Dideriksen, M.D. 0045 40832508 johndide@rm.dk

Locations
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Denmark
Department of cardiology, Research, Aarhus University Hospital, Denmark Not yet recruiting
Aarhus, Denmark, 8200
Contact: Johnni T. R. Dideriksen, M.D.    0045 40832508    johndide@rm.dk   
Sponsors and Collaborators
University of Aarhus

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03024047     History of Changes
Other Study ID Numbers: DAN-BLOCK_Study1
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Genetic Diseases, Inborn
Atrioventricular Block
Cardiac Conduction System Disease
Bundle-Branch Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes