Clinical Trial: Cohort Description of Younger With AV-block

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title:

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 tec

Detailed Summary:

Method:

The following covariates will be reported.

Date of diagnosis of AV-block:

The date of diagnosis is defined as the day the physician diagnoses the AV-block. E.g. if the patient has a Holter monitoring performed, the date of diagnosis is the dag the monitoring is reviewed.

Reported as: Day-month-year

Comorbidity at day of first pacemaker implant:

Registered as one or more of the following:

  1. Diabetes
  2. Hypertension
  3. Hypercholesterolemia
  4. Heart failure
  5. Atrial fibrillation or flutter
  6. Ischemic heart disease
  7. Sarcoidosis
  8. Connecting tissue disorder
  9. Other

Smoking status at day of first pacemaker implant:

Registered as: Current, former, never

Device selected at first pacemaker implant:

Registered as: DDD, CTR, etcetera

Genetic investigation:

Is there performed genetic investigation due to the finding of AV-block? Investigation must be initiated maximum 4 weeks after day of first pacemaker implant.

Registered as: y/n.

Sponsor: University of Aarhus

Current Primary Outcome:

  • Prevalence of structural heart disease as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of ischemic heart disease as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of congenital heart disease as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of congenital AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of muscular dystrophy as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of sarcoidosis as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of lyme disease as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of genetic cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of complications to operation as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of complications to radio frequency ablation as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of endocarditis as cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]
  • Prevalence of unknown cause of AV-block [ Time Frame: 01.01.1996 - 31.12.2015 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Aarhus

Dates:
Date Received: January 4, 2017
Date Started: January 2017
Date Completion:
Last Updated: January 13, 2017
Last Verified: January 2017