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Atrioventricular BlockNCT03024047

Cohort Description of Younger With AV-block

An observational study of Atrioventricular Block and Progressive Cardiac Conduction Defect, run by University of Aarhus at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 49 years
What is being tested?
Pacemaker
Type of treatment
Medical device
How many people
1,255 participants
Where
1 siteDenmark
Study dates
Jan 2017to Aug 2018
Phase
Observational
Are there results?
None posted in the registry

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 Up to 49 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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).

Who may be able to join

  • 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

Who cannot join

  • Non

Trial locations and contacts

1 site in 1 country.

Johnni T. R. Dideriksen, M.D. contact

0045 40832508

johndide@rm.dk

Denmark1 site
  • Department of cardiology, Research, Aarhus University Hospital, Denmark

    Aarhus, 8200

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

Other trials in Denmark

About this study

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.

Read more

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.

Read the detailed description

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.

Date of first pacemaker implant:

Registered as: Day-month-year

Implant sight

ECG 12 description:

ECG 12 must be taken maximum one week before day of first pacemaker implant Registered as: Bpm., RBBB y/n, LBBB y/n, PR in msec, QRS in msec, QT in msec, QTc in msec (Frederica)

Implant indication:

Registered as one of following:

  1. First-degree atrioventricular block with symptoms
  2. Mobitz type 1 with symptoms
  3. Mobitz type 2
  4. Advanced second-degree atrioventricular block
  5. Third-degree atrioventricular block
  6. Unknown The most malignant is chosen and it is reported if it is intermittent or persistent.

Symptoms:

Registered as one or more of following:

  1. Dyspnoea
  2. Fatigue
  3. Malaise
  4. Dizziness
  5. Syncope
  6. Angina
  7. Cardiac arrest
  8. No symptoms

Echocardiography:

Performed maximum two weeks before day of first pacemaker implant The reported values are what the echocardiographer describes.

Registered as:

LVEF in % (values over 60% is reported as >60 %) Hypertrophy of LV y/n Dilatation of LV y/n Dilatation of LA y/n Valvular disease/artificial valve y/n

Coronary angiography:

At day of first pacemaker implant +/- 4 weeks

Registered as:

Normal y/n Significantly disease on LAD y/n Significantly disease on RCA y/n Significantly disease on CX y/n Significantly disease = leading to CABG, PCI or antithrombotic treatment

Being tested
Pacemaker
Medical subject headings
Atrioventricular Block, Bundle-Branch Block, Genetic Diseases, Inborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PacemakerDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of structural heart disease as cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

  2. Prevalence of ischemic heart disease as cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

  3. Prevalence of congenital heart disease as cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

  4. Prevalence of congenital AV-block

    Measured: 01.01.1996 - 31.12.2015

  5. Prevalence of muscular dystrophy as cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

  6. Prevalence of sarcoidosis as cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

  7. Prevalence of lyme disease as cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

  8. Prevalence of genetic cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

  9. Prevalence of complications to operation as cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

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

    Measured: 01.01.1996 - 31.12.2015

  11. Prevalence of endocarditis as cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

  12. Prevalence of unknown cause of AV-block

    Measured: 01.01.1996 - 31.12.2015

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionAug 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
1,255 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03024047
Sponsor's protocol ID
DAN-BLOCK_Study1
Status last verified
Jan 2017
First submitted
4 Jan 2017
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Atrioventricular Block and Progressive Cardiac Conduction Defect, run by University of Aarhus at 1 site in Denmark.

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 1 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: status not confirmed, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Johnni T. R. Dideriksen, M.D. (0045 40832508, johndide@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of structural heart disease as cause of AV-block (time frame: 01.01.1996 - 31.12.2015). The study lists 12 primary outcomes in all. 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 18 Jan 2017.

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