Beat-to-beat Variability in Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— BVAR-Afib  

Official title:

Beat-to-beat Variability in Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092362
• Other study ID #: HDZNRW-KA-009-HO
• Status: Completed
• Start date: November 2016
• Est. completion date: June 2020

Study information

• Verified date: July 2020
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Heart and Diabetes Center NRW	Bad Oeynhausen	North Rhine Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation symptoms	Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate variability	7 days
Secondary	Atrial fibrillation symptoms	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).	7 days
Secondary	Improvement in 6MWD (6 minutes walk distance)	Whether 6MWD improvement after treatment of atrial fibrillation correlates with heart rate variability.	7 days