Beat-to-beat Variability in Persistent Atrial Fibrillation

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.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart and Diabetes Center NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Atrial fibrillation symptoms

Time frame: 7 days

Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate variability

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Acronym: BVAR-Afib

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Mar 27, 2017
Registry last updated: Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed