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Atrial FibrillationAFISBIONCT03855540

Atrial Fibrillation in Relationship to Sleep Quality and Plasma Biomarkers

An observational study of Atrial Fibrillation, run by Premedix Academy at 4 sites in Slovakia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
ECHOcardiography, Peripheral blood samples for plasmatic biomarkers and Athens insomnia scale questionnaire
How many people
200 participants
Where
4 sitesSlovakia
Study dates
11 Apr 2018to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Slovak hospitals and outpatients clinics

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Allan Bohm, MD contact

+421259320111

allan.bohm@gmail.com

Slovakia4 sites, 4 recruiting
  • Allan Bohm

    Bratislava, 81102

    Allan Bohm, MD, 0259320111, allan.bohm@gmail.com

    Recruiting
  • East Slovak Institute of Cardiovascular Diseases

    Košice

    Marianna Vachalcová, MD, 421914241352, vachalcova@gmail.com

    Recruiting
  • Hospital

    Malacky

    Tomas Uher, MD, uher@gmail.com

    Recruiting
  • University hospital

    Nitra

    Peter Snopek, MD, snopek@gmail.com

    Viera Kissová, MD

    Recruiting

Other trials in Slovakia

About this study

Official title: AFISBIO - Atrial Fibrillation in Relationship to Sleep Quality and Plasma Biomarkers.

  1. Compare the plasmatic biomarkers between the cohort with and without AFib.
  2. Find sensitive and specific biomarkers that could be used for the diagnostic management of AFib.
  3. Compare the quality of sleep between the cohort with and without AFib by the means of sleeping quality questionnaire
Read the 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 subclinical. Detection of subclinical AFib is highly challenging as only a minority of the patients is diagnosed during a standard examinations with a 12 - lead ECG or a 24h ECG Holter monitoring. Documented AFib causes 15% of ischemic strokes, however approximately 25% of ischemic strokes is of an unknown etiology. It is believed that undetected subclinical AFib is responsible for these strokes. There is also evidence that asymptomatic AFib is associated with a higher incidence of strokes in comparison to symptomatic AFib.

Due to the fact that the standard ECG examination is not sufficient for AFib detection, various ECG screening methods have been introduced. Intermittent short ECG recording seems to be more effective than 24-hour Holter ECG in the detection of the arrhythmia however, it is not known whether it is superior to the 7 - day ECG Holter monitoring.

Plasmatic biomarkers might be of a paramount importance in the diagnostic management.

Several plasmatic biomarkers were tested to find an association with AFib. Perhaps the most studied ones were the natriuretic peptides that showed to be significantly increased in patients with AFib. Similarly, high sensitivity troponins are elevated in patients with the AFib. Another marker of left atrial stretching and also of ionotropic effects is apelin. Patients with lone AFib showed a significantly decreased levels of this peptide. Conflicting results were shown in studies with inflammatory biomarkers such as high sensitivity CRP Parameters reflecting thrombogenesis were also found to be associated with the arrhythmia. Fibrinogen and fibrin D-dimer were significantly increased in paroxysmal AFib. Finally, in the last years, the circulating micro RNAs emerged as a promising biomarker of AFib, having important function in suppression of messenger RNA responsible for thrombogenesis and ionotropic functions.

The weakness of the mentioned studies is, that the biomarkers were usually tested in patients with a few comorbidities. So, it is not known whether these biomarkers are specific for AFib "per se" or whether they just reflect pathophysiological mechanisms like inflammation, fibrogenesis or left atrium stretching that is also present in other cardiovascular diseases. Furthermore, the AFib cohorts were often not matched with the control groups adding more uncertainty. To clarify these questions, we designed a study where plasmatic biomarkers will be studied in high risk cohort of patients with AFib having several cardiovascular comorbidities. These patients will be subsequently matched with a control group according to the age, gender and the cardiovascular comorbidities.

Similarly, as the continuum of organic changes of the heart from the left ventricular diastolic dysfunction, left atrial dilatation ending with heart failure, there is also "arrhythmology continuum" in patients with arterial hypertension to supraventricular premature contractions via paroxysmal tachycardia of fibrillation up to the permanent atrial fibrillation (AFib). A common etiopathology factor of these disorders is increased sympathetic activity, which together with the catecholamine release during the stress causes arrhythmogenic substrates due to the atrial fibrogenesis. The relation between sleep disorders and the AFib is poorly understood. Micro awakenings during the night increases sympathetic activity and the arterial blood pressure. Other possible mechanism might be the decrease of plasmatic melatonin related to aging. Sleep disorders are linked to the increased heart rate, worsening of the heart rate variability, increased metabolism and body temperature, increased beta EEG activity and activation of the hypothalamic - pituitary - adrenal axis. In patients with arterial hypertension, there is an increased occurrence of premature atrial contractions that is linked to increased risk of AF incidence.

Being tested
ECHOcardiography, Peripheral blood samples for plasmatic biomarkers, Athens insomnia scale questionnaire, ECG Holter monitor, ECG event recorder
Keywords
Atrial fibrillation, ECG monitoring, quality of sleep, plasmatic biomarkers
Medical subject headings
Atrial Fibrillation, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECHOcardiographyDiagnostic test

    ECHO parameters

    1. LA diameter
    2. LVEDD
    3. LVEF
    4. Diastolic dysfunction
    5. Valvular disease
  • Peripheral blood samples for plasmatic biomarkersDiagnostic test

    1. Coagulation
    • D - dimer
    • Fibrinogen
    1. Inflammation and fibrosis
    • Hs - CRP
    • AGEs
    • Soluble RAGE
    1. Hemodynamics (LA stretch)
    • Apelin
    • NT - proBNP
    • Hs - troponin
    1. MiRNA
    • miRNA - 1
    • miRNA - 133
    • miRNA - 29b
    • miRNA - 208a
    • miRNA - 208b
    • miRNA - 499
  • Athens insomnia scale questionnaireDiagnostic test

    Athens insomnia scale questionnaire

  • ECG Holter monitorDiagnostic test

    Patient receives ECG Holter monitor if included to the control group

  • ECG event recorderDiagnostic test

    Patient receives ECG event recorder for twice daily (or if symptoms), 90 seconds duration ECG monitoring if included to the control group

Study groups in NCT03855540
Study groupRoleWhat they receive
Study groupAdult 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.
Receives: Diagnostic Test: ECHOcardiography; Diagnostic Test: Peripheral blood samples for plasmatic biomarkers; Diagnostic Test: Athens insomnia scale questionnaire
Control groupPatients 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)
Receives: Diagnostic Test: ECHOcardiography; Diagnostic Test: Peripheral blood samples for plasmatic biomarkers; Diagnostic Test: Athens insomnia scale questionnaire; Diagnostic Test: ECG Holter monitor; Diagnostic Test: ECG event recorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day of inclusion

  2. 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.

    Measured: Day of inclusion

Secondary outcomes (1)
  1. Diagnostic plasmatic biomarker

    Find sensitive and specific biomarker that could be used for the diagnostic management of 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

    Measured: Day of inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2019
  2. Study start11 Apr 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03855540
Sponsor's protocol ID
0012018
Acronym
AFISBIO
Status last verified
Mar 2019
First submitted
5 Dec 2018
Last updated
29 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Premedix Academy at 4 sites in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Allan Bohm, MD (+421259320111, allan.bohm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasmatic biomarkers (time frame: Day of inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.

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