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Trial record 76 of 1655 for:    Slovakia

Atrial Fibrillation in Relationship to Sleep Quality and Plasma Biomarkers (AFISBIO)

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ClinicalTrials.gov Identifier: NCT03855540
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
NGO: Research Institute of Academy

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


Condition or disease Intervention/treatment
Atrial Fibrillation 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

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: AFISBIO - Atrial Fibrillation in Relationship to Sleep Quality and Plasma Biomarkers.
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Diagnostic Test: ECHOcardiography

ECHO parameters

  1. LA diameter
  2. LVEDD
  3. LVEF
  4. Diastolic dysfunction
  5. Valvular disease

Diagnostic Test: Peripheral blood samples for plasmatic biomarkers
  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

Diagnostic Test: Athens insomnia scale questionnaire
Athens insomnia scale questionnaire

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)
Diagnostic Test: ECHOcardiography

ECHO parameters

  1. LA diameter
  2. LVEDD
  3. LVEF
  4. Diastolic dysfunction
  5. Valvular disease

Diagnostic Test: Peripheral blood samples for plasmatic biomarkers
  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

Diagnostic Test: Athens insomnia scale questionnaire
Athens insomnia scale questionnaire

Diagnostic Test: ECG Holter monitor
Patient receives ECG Holter monitor if included to the control group

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




Primary Outcome Measures :
  1. Plasmatic biomarkers [ Time Frame: Day of inclusion ]

    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

  2. Quality of sleep [ Time Frame: Day of inclusion ]
    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.


Secondary Outcome Measures :
  1. Diagnostic plasmatic biomarker [ Time Frame: Day of inclusion ]

    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


Biospecimen Retention:   Samples With DNA
serum, plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Slovak hospitals and outpatients clinics
Criteria

Inclusion Criteria: 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 Criteria: 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855540


Contacts
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Contact: Allan Bohm, MD +421259320111 allan.bohm@gmail.com

Locations
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Slovakia
Allan Bohm Recruiting
Bratislava, Slovakia, 81102
Contact: Allan Bohm, MD    0259320111    allan.bohm@gmail.com   
East Slovak Institute of Cardiovascular Diseases Recruiting
Košice, Slovakia
Contact: Marianna Vachalcová, MD    421914241352    vachalcova@gmail.com   
Hospital Recruiting
Malacky, Slovakia
Contact: Tomas Uher, MD       uher@gmail.com   
University hospital Recruiting
Nitra, Slovakia
Contact: Peter Snopek, MD       snopek@gmail.com   
Contact: Viera Kissová, MD         
Sub-Investigator: Monika Urbanová, MD         
Sponsors and Collaborators
NGO: Research Institute of Academy
Investigators
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Principal Investigator: Allan Bohm, MD The National Institution of Cardiovascular Diseases
Principal Investigator: Stefan Farsky, Associate professor Slovak league against hypertension

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Responsible Party: NGO: Research Institute of Academy
ClinicalTrials.gov Identifier: NCT03855540     History of Changes
Other Study ID Numbers: 0012018
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NGO: Research Institute of Academy:
Atrial fibrillation
ECG monitoring
quality of sleep
plasmatic biomarkers
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes