Beat-to-beat Variability in Persistent Atrial Fibrillation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03092362

Acronym

BVAR-Afib

Enrollment

Registered

2017-03-27

Start date

2016-11-30

Completion date

2020-06-30

Last updated

2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation, Heart rate variability, quality of life

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Atrial fibrillation symptoms	7 days	Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate variability

Secondary

Measure	Time frame	Description
Atrial fibrillation symptoms	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)	7 days	Whether 6MWD improvement after treatment of atrial fibrillation correlates with heart rate variability.

Countries

Germany

Outcome results