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Completed

NCT Number: NCT02615587

Burden of Illness in Atrial Fibrillation

The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary and secondary diagnosis with AF;
  • The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included.

Exclusion criteria

  • Patients younger than 18 and older than 90 years of age.

Treatment and study plan

Standard of care in AF in Denmark

Drug

As used in clinical practice, analysed as per drug class, not separate drugs.

Primary outcomes

  1. Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+

    Time frame: up to 4 weeks

  2. Number of newly diagnosed patients with (non-valvular) AF per year in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+

    Time frame: up to 4 weeks

  3. Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+

    Time frame: up to 4 weeks

  4. Number of newly diagnosed patients with (non-valvular) AF per year and per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+

    Time frame: up to 4 weeks

  5. Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group

    Time frame: up to 4 weeks

  6. Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+

    Time frame: up to 4 weeks

  7. Number of newly diagnosed patients with stroke in (non-valvular) AF-patients per year in Denmark by gender and age groups 18-65, 66-75, 75+, 80+

    Time frame: up to 4 weeks

  8. Mortality among stroke patients (in AF) compared with that of the population/the 'controls' and the total AF-population, if possible by gender and age group

    Time frame: up to 4 weeks

  9. Direct cost in AF (in total and per patient)

    Time frame: up to 4 weeks

    Costs due to:

    Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine

    Cost will be shown:

    For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes

  10. Direct cost in AF-related stroke (in total and per patient)

    Time frame: up to 4 weeks

    Costs due to:

    Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine

    Cost will be shown:

    For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes

  11. Indirect cost in AF (in total and per patient)

    Time frame: up to 4 weeks

    Costs due to:

    Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities

    Cost will be shown:

    For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes

  12. Indirect cost in AF-related stroke (in total and per patient)

    Time frame: up to 4 weeks

    Costs due to:

    Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities

    Cost will be shown:

    For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes

Secondary outcomes

  1. Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population

    Time frame: up to 4 weeks

    CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)

  2. Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population

    Time frame: up to 4 weeks

    CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)

  3. Number of patients with AF-related stroke rated per average CHADS-score in Danish population

    Time frame: up to 4 weeks

  4. Percentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish populationPercentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish population

    Time frame: up to 4 weeks

  5. Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population

    Time frame: up to 4 weeks

  6. Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population

    Time frame: up to 4 weeks

  7. Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population

    Time frame: up to 4 weeks

  8. Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population

    Time frame: up to 4 weeks

  9. Number of patients per average HAS-BLED-score in Danish AF-population

    Time frame: up to 4 weeks

  10. Percentage (%) of patients per average HAS-BLED-score in Danish AF-population

    Time frame: up to 4 weeks

  11. Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]

    Time frame: up to 4 weeks

  12. Number of patients in total and per CH2ADS2-VASc-score receiving warfarin

    Time frame: up to 4 weeks

  13. Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]

    Time frame: up to 4 weeks

  14. Number of patients in total and per CH2ADS2-VASc-score receiving no treatment

    Time frame: up to 4 weeks

  15. Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA]

    Time frame: up to 4 weeks

  16. Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin

    Time frame: up to 4 weeks

  17. Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs]

    Time frame: up to 4 weeks

  18. Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment

    Time frame: up to 4 weeks

  19. Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total

    Time frame: up to 4 weeks

  20. Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total

    Time frame: up to 4 weeks

  21. Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score

    Time frame: up to 4 weeks

  22. Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score

    Time frame: up to 4 weeks

  23. Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting

    Time frame: up to 4 weeks

    Based on data from the National Patient Registry, the Primary Care Registry and the Registry of Medicinal Product Statistics and inclusion codes for specific fees/services, it will be possible to identify which patients are treated in an AC-clinic and which patients are treated in a GP-setting

  24. Direct and indirect cost of AC medication treatment patterns

    Time frame: up to 4 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Burden of Illness in Atrial Fibrillation in Denmark

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2015
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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