NCT03092362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 7, 2020

Status Verified

July 1, 2020

Enrollment Period

3.6 years

First QC Date

March 21, 2017

Last Update Submit

August 6, 2020

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillationHeart rate variabilityquality of life

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation symptoms

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

    7 days

Secondary Outcomes (2)

  • Atrial fibrillation symptoms

    7 days

  • Improvement in 6MWD (6 minutes walk distance)

    7 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Persistent atrial fibrillation
  • No previous ablation for atrial fibrillation
  • At least 18 years old
  • Signed written patient's informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Diabetes Center NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related 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.

    PMID: 26298305BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hazem Omran, MD

    HDZ NRW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

November 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

August 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)