Beat-to-beat Variability in Persistent Atrial Fibrillation

Overview

Heart rate variability (HRV) in patients with atrial fibrillation (AF) is hardly studied. Though a reduced HRV in patients with heart failure and reduced ejection fraction (HFrEF) has been associated with poor prognosis. Data on HRV in AF-patients without a reduced ejection fraction is lacking. We hypothesize that those patients with persistent atrial fibrillation and larger beat-to-beat variability would be more symptomatic than does those with smaller HRV. To asses this theory we intend to perform a prospective observational trial. Symptoms of Atrial fibrillation will be assessed using Quality of Life questionnaires and 6 minutes walking test. Heart rate variability will be assessed using 24 hour Holter ECG monitoring.

The correlation between symptoms and heart rate variability will be then assessed.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2020

Clinical Trial Outcome Measures

Primary Measures

  • Atrial fibrillation symptoms
    • Time Frame: 7 days
    • Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate variability

Secondary Measures

  • Atrial fibrillation symptoms
    • Time Frame: 7 days
    • Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate reserve. Heart rate reserve is defined as the difference between maximal heart rate (220- age in years) and mean heart rate during atrial fibrillation (assessed by 24 hour Holter ECG monitoring).
  • Improvement in 6MWD (6 minutes walk distance)
    • Time Frame: 7 days
    • Whether 6MWD improvement after treatment of atrial fibrillation correlates with heart rate variability.

Participating in This Clinical Trial

Inclusion Criteria

  • Persistent atrial fibrillation
  • No previous ablation for atrial fibrillation
  • At least 18 years old
  • Signed written patient's informed consent

Exclusion Criteria

  • Paroxysmal atrial fibrillation
  • Previous ablation therapy for atrial fibrillation
  • Reduced left ventricular ejection fraction (LVEF<35%)
  • Permanent ventricular pacing (including cardiac resynchronization therapy CRT)
  • Acute coronary syndrome (ACS) during past 6 weeks.
  • Stroke or TIA within past 6 weeks.
  • Cardiac surgical operation/ intervention within past 3 months.
  • Acute decompensated heart failure
  • Treatment with IV Inotropic medications (e.g. Dobutamine, Levosimendan)
  • Mitral valve replacement or rheumatic mitral valve stenosis
  • Neurological or psychological disease that may impair patient's judgement or compliance
  • Pregnancy or Breast-feeding women.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heart and Diabetes Center North-Rhine Westfalia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hazem Omran, MD, Principal Investigator, HDZ NRW

References

Cygankiewicz I, Corino V, Vazquez R, Bayes-Genis A, Mainardi L, Zareba W, de Luna AB, Platonov PG; MUSIC Trial Investigators. Reduced Irregularity of Ventricular Response During Atrial Fibrillation and Long-term Outcome in Patients With Heart Failure. Am J Cardiol. 2015 Oct 1;116(7):1071-5. doi: 10.1016/j.amjcard.2015.06.043. Epub 2015 Jul 16.

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