Treatment of Atrial Fibrillation in Finland (FinFib2)

Treatment of Atrial Fibrillation in Finland - the FinFib 2 Study

FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation in Finland. The investigators hypothesis is that the treatment of atrial fibrillation has improved since the introduction of new antiarrhythmic drugs and anticoagulants.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

Detailed Description

FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation (AF) in Finland. It will produce important information such as whether the introduction of the new agents has taken place in accordance with the treatment guidelines in different parts of Finland.

Working hypothesis is that the treatment of AF has improved since the introduction of new antiarrhythmic drugs and anticoagulants. However, the investigators also expect to find out that there are geographical differences in the use of these agents. The expect outcome is that the investigators will identify these differences and be able to better homogenize the treatment of AF in different parts of the country and different levels of the health care system.

The study data will be obtained in the form of a cross-section sampling over two weeks. All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. The investigators estimate the number of patients will be about 1000. Aside from background information, risk data (e.g. CHA2DS2VASc), symptoms (EHRA classification), medication, examinations and the choice of treatment, the only data recorded about each patient with AF will be date of birth and gender. The patients will be divided into four groups according to type of AF: 1. New onset AF, 2. Paroxysmal AF, 3. Persistent AF, 4. Permanent AF. The data will be obtained by the local study doctor using online, protected data collection program. The data will be stored on a secured server, which can be accessed for data entry by the investigators at the study centers. The database is not a personal data register, as identity codes will not be stored at any point and individual patients cannot be identified later through the database. Only the investigator group will have the rights to use the database.

• Study Type: Observational
• Enrollment (Actual): 1013

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Central Hospital
  • Kuopio, Finland
    • Kuopio University Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Tampere, Finland
    • Tampere University Hospital
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study data will be obtained in the form of a cross-section sampling over two weeks. All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. The estimated number of patients is about 1000.

Description

Inclusion Criteria:

All adult patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with AF in the ER; All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to current atrial fibrillation treatment guidelines	All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included for assessment of the adherence of their treatment to current guidelines.	Data collected during the ER visit

Collaborators and Investigators

• Sponsor: Finnish Cardiac Society
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Oulu University Hospital; Kuopio University Hospital; Tampere University Hospital
• Investigators: Study Chair: Pekka Raatikainen, MD, PhD, Heart Center Tampere Univerisity Hospital; Principal Investigator: Juha Hartikainen, MD, Kuopio University Hospital; Principal Investigator: Timo Lauri, MD, Oulu University Hospital; Principal Investigator: Mika Lehto, MD, Helsinki University Central Hospital; Principal Investigator: Markku Mäkijärvi, MD, Helsinki University Central Hospital; Principal Investigator: Juha Lund, MD, Turku University Hospital; Principal Investigator: Heikki Mäkynen, MD, Heart Center Tampere University Hospital

Publications and helpful links

General Publications

• Penttila T, Makynen H, Hartikainen J, Hyppola H, Lauri T, Lehto M, Lund J, Raatikainen MJP; FinFib2 investigators. Antiarrhythmic drug therapy among patients presenting to emergency department with symptomatic atrial fibrillation - a prospective nationwide cohort. Scand J Trauma Resusc Emerg Med. 2017 Aug 15;25(1):81. doi: 10.1186/s13049-017-0424-7.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: atrial fibrillation; anticoagulation; antiarrhythmic medication; CHA2DS2VASc score; HAS-BLED score; CHADS2 score
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: FCS-2013-1; R13044 (Other Identifier: The Pirkanmaa Hospital District Ethical Committee)