Condition category
Circulatory System
Date applied
09/03/2010
Date assigned
06/04/2010
Last edited
06/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Robert Hatala

ORCID ID

Contact details

Národný ústav srdcových a cievnych chorôb
Pod Krásnou hôrkou 1
Bratislava 37
833 48
Slovakia
hatala@nusch.sk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009, protocol version 6.0, 18.01.2010

Study information

Scientific title

Project REAL FIB - atrial fibrillation in real Praxis register: a multicentre, non-interventional, observational and prospective study

Acronym

REAL FIB

Study hypothesis

Charting of therapeutic methods indicated by medical doctors of different specialisations (cardiologists, internists) in prevention of atrial fibrillation from all over the country.

Ethics approval

Multicentric Ethics Committee approved on the 21st December 2009 (ref: 108728/2009-11)

Study design

Multicentre non-interventional observational prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Atrial fibrillation (AF)

Intervention

This is a non-interventional study, all interventions will be performed according to common clinical Praxis in the management and follow up of patients with atrial fibrillation on treatment.

Baseline visit:
1. Demographic data collection
2. Risk factors assessment: height, weight, age, patient history (hypertension, age when AF diagnosed, coronary disease, heart failure, New York Heart Association [NYHA] classification, systolic dysfunction, ejection fraction, diastolic dysfunction, sick sinus syndrome, cardiostimulator, implantable cardioverter-defibrillator [ICD], history of cardiovascular surgery, other heart diseases, mitral valve disease and type, diabetes mellitus), blood sugar level, dyslipidaemia, cholesterol level, low density lipoprotein [LDL]-cholesterol level, chronic renal insufficiency, creatinine, urea, ions, thyreopathy, body mass index [BMI], transient ischaemic attack [TIA]/cerebrovascular accident [CVA], alcohol abuse, family history for AF, CHADS score
3. AF characteristics
4. Treatment strategy (rhythm control, frequency control, thrombembolism prevention, other treatment)

Follow up (6 months):
1. Basic data
2. Accidental events
3. Treatment strategy

Follow up (12 months):
1. Basic data
2. Accidental events
3. Treatment strategy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. To assess clinical profile of patients with atrial fibrillation
2. To assess contemporary treatment modalities and its effectiveness
3. To observe occurence of cardiovascular events prospectively

Secondary outcome measures

1. To analyse correlation between treatment modalities indicated by medical doctors of different specialisations (cardiologists, internists) in prevention of atrial fibrillation
2. To collect treatment safety data

Overall trial start date

01/02/2010

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

All patients diagnosed with atrial fibrillation (any age, either sex)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/02/2010

Recruitment end date

30/04/2011

Locations

Countries of recruitment

Slovakia

Trial participating centre

Národný ústav srdcových a cievnych chorôb
Bratislava 37
833 48
Slovakia

Sponsor information

Organisation

Masaryk University (Czech Republic)

Sponsor details

c/o Doc. RNDr. Ladislav Dušek
Ph.D.
Institute of Biostatistics and Analyses
Faculty of Medicine and the Faculty of Science
Kamenice 2
Brno-Bohunice
625 00
Czech Republic
dusek@iba.muni.cz

Sponsor type

University/education

Website

http://www.muni.cz/

Funders

Funder type

University/education

Funder name

Masaryk University (Czech Republic) - Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes