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 Duek
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
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