Clinical trial NCT03092362: Beat-to-beat Variability in Persistent Atrial Fibrillation
Official title: Beat-to-beat Variability in Persistent Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation
Heart rate variability
quality of life
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with persistent atrial fibrillation (defined as lasting more than seven days or requiring termination by cardioversion either with drugs or by direct current cardioversion) who are admitted at our clinic.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Atrial fibrillation symptoms
timeFrame: 7 days
Secondary outcomes:
measure: Atrial fibrillation symptoms
timeFrame: 7 days
measure: Improvement in 6MWD (6 minutes walk distance)
timeFrame: 7 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center NRW
state: North Rhine Westphalia
Study officials:
affiliation: HDZ NRW
name: Hazem Omran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.