Beat-to-beat Variability in Persistent Atrial Fibrillation

NCT ID: NCT03092362

Last Updated: 2020-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hazem Omran, MD

Role: PRINCIPAL_INVESTIGATOR

HDZ NRW

Locations

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Heart and Diabetes Center NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 26298305 (View on PubMed)

Other Identifiers

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HDZNRW-KA-009-HO

Identifier Type: -

Identifier Source: org_study_id

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