Atrial Fibrillation in Relationship to Sleep Quality and Plasma Biomarkers
AFISBIO
AFISBIO - Atrial Fibrillation in Relationship to Sleep Quality and Plasma Biomarkers.
1 other identifier
observational
200
1 country
4
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 quality of sleep between the cohort with and without AFib by the means of sleeping quality questionnaire
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2018
CompletedFirst Submitted
Initial submission to the registry
December 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 29, 2019
March 1, 2019
1.7 years
December 5, 2018
March 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Plasmatic biomarkers
Compare the plasmatic biomarkers between the cohort with and without atrial fibrillation: 1. Coagulation a D - dimer b Fibrinogen 2. Inflammation and fibrosis a Hs - CRP b AGEs c Soluble RAGE 3. Hemodynamics (LA stretch) a Apelin b NT - proBNP c Hs - troponin 4. MicroRNA a miRNA - 1 b miRNA - 19 c miRNA - 21 d miRNA - 124 e miRNA - 150 f miRNA - 328
Day of inclusion
Quality of sleep
Compare the quality of sleep between the cohort with and without atrial fibrillation by the means of Athens Insomnia Scale (AIS). It is measured by assessing eight factors amongst which first five factors are related to nocturnal sleep and last three factors are related to daytime dysfunction. These are rated on a 0-3 scale and the sleep is finally evaluated from the cumulative score of all factors and reported as an individual's sleep outcome. A cut-off score of ≥6 on the AIS is used to establish the diagnosis of insomnia.
Day of inclusion
Secondary Outcomes (1)
Diagnostic plasmatic biomarker
Day of inclusion
Study Arms (2)
Study group
Adult patients with documented paroxysmal, nonvalvular atrial fibrillation with CHA2DS2-VASc score \> 2 (for females \> 3) and sinus rhythm at the time of inclusion. In total 100 patients will be included.
Control group
Patients without a history of palpitations or irregular heart rhythm. AFib will be excluded with the help of 7 days ECG Holter and ECG event recorder monitoring. In total 100 patients will be included. Propensity matching according to the: * CHA2DS2-VASc parameters * LVEF: preserved (\<40%), mid-range (40-49%) and reduced (\>50%) * Presence of diastolic dysfunction * Glomerular filtration rate: (≥1,5 ml/s), (1,4-1 ml/s) and (0,9-0,5 ml/s) * Drugs: ACE-I/ARB, betablockers, digoxin, amiodarone * BMI: (\<30kg/m2), (30-39kg/m2) and (≥40kg/m2) * Smoking (\>5 cigarettes per day)
Interventions
ECHO parameters 1. LA diameter 2. LVEDD 3. LVEF 4. Diastolic dysfunction 5. Valvular disease
1. Coagulation * D - dimer * Fibrinogen 2. Inflammation and fibrosis * Hs - CRP * AGEs * Soluble RAGE 3. Hemodynamics (LA stretch) * Apelin * NT - proBNP * Hs - troponin 4. MiRNA * miRNA - 1 * miRNA - 133 * miRNA - 29b * miRNA - 208a * miRNA - 208b * miRNA - 499
Athens insomnia scale questionnaire
Patient receives ECG Holter monitor if included to the control group
Patient receives ECG event recorder for twice daily (or if symptoms), 90 seconds duration ECG monitoring if included to the control group
Eligibility Criteria
Slovak hospitals and outpatients clinics
You may qualify if:
- 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
- No history of palpitations
- Propensity matching
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Premedix Academylead
Study Sites (4)
Allan Bohm
Bratislava, 81102, Slovakia
East Slovak Institute of Cardiovascular Diseases
Košice, Slovakia
Hospital
Malacky, Slovakia
University hospital
Nitra, Slovakia
Biospecimen
serum, plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allan Bohm, MD
The National Institution of Cardiovascular Diseases
- PRINCIPAL INVESTIGATOR
Stefan Farsky, Associate professor
Slovak league against hypertension
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2018
First Posted
February 26, 2019
Study Start
April 11, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share