Beat-to-beat Variability in Persistent Atrial Fibrillation (BVAR-Afib)

August 6, 2020 updated by: Heart and Diabetes Center North-Rhine Westfalia

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine Westphalia
      • Bad Oeynhausen, North Rhine Westphalia, Germany, 32545
        • Heart and Diabetes Center NRW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation symptoms
Time Frame: 7 days
Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate variability
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 days
Improvement in 6MWD (6 minutes walk distance)
Time Frame: 7 days
Whether 6MWD improvement after treatment of atrial fibrillation correlates with heart rate variability.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Investigators

  • Principal Investigator: Hazem Omran, MD, HDZ NRW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 24, 2017

First Posted (ACTUAL)

March 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZNRW-KA-009-HO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Persistent Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe