Status:
UNKNOWN
Atrial Fibrillation in Relationship to Sleep Quality and Plasma Biomarkers
Lead Sponsor:
Premedix Academy
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
A. Compare the plasmatic biomarkers between the cohort with and without AFib. B. Find sensitive and specific biomarkers that could be used for the diagnostic management of AFib. C. Compare the quali...
Detailed Description
AFib is the most common sustained arrhythmia, associated with an increased risk of stroke, heart failure, and mortality. Despite the high prevalence, AFib may be asymptomatic and consequently subclini...
Eligibility Criteria
Inclusion
- The specific criteria for inclusion in the study group are:
- Age \>17 years
- Documented, nonvalvular paroxysmal AFib in the duration of more than 6 min. (medical history or ECG monitoring)
- CHA2DS2-VASc score \> 2 for males
- CHA2DS2-VASc score \> 3 for females
- Sinus rhythm at the time of inclusion
- The specific criteria for inclusion in the control group are:
- No history of palpitations
- AFib exclusion with the 7 days ECG Holter and ECG event recorder monitoring
- Propensity matching
Exclusion
- Exclusion criteria for both groups:
- Electrical cardioversion less than 7 days prior to inclusion
- Acute coronary syndrome less than 1 month prior to inclusion
- Cardiac surgery less than 3 months prior to inclusion
- Acute or decompensated heart failureat the time of inclusion
- Pregnancy
- Cardiomyopathy
- Alcoholism (≥ 8 drinks/week)
- Thyrotoxicosis
- Renal Disease (Dialysis/ transplant/CrCl \< 0,5ml/s)
- Liver disease (cirrhosis/ transaminase \> 3x ULT/ bilirubin \> 2x ULT)
- Mechanical proshetic valves
- Severe mitral stenosis
- Class I and IV antiarrhythmic drugs usage in last month
- Class III antiarrhythmic drugs usagein last 3 months
Key Trial Info
Start Date :
April 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03855540
Start Date
April 11 2018
End Date
December 31 2019
Last Update
March 29 2019
Active Locations (4)
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1
Allan Bohm
Bratislava, Slovakia, 81102
2
East Slovak Institute of Cardiovascular Diseases
Košice, Slovakia
3
Hospital
Malacky, Slovakia
4
University hospital
Nitra, Slovakia