Persistent Atrial FibrillationBVAR-AfibNCT03092362
Beat-to-beat Variability in Persistent Atrial Fibrillation
An observational study of Persistent Atrial Fibrillation, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Persistent atrial fibrillation
- No previous ablation for atrial fibrillation
- At least 18 years old
- Signed written patient's informed consent
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart and Diabetes Center NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
About this study
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.
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- persistent atrial fibrillation, Heart rate variability, quality of life
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation symptoms
Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate variability
Measured: 7 days
Secondary outcomes (2)
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).
Measured: 7 days
Improvement in 6MWD (6 minutes walk distance)
Whether 6MWD improvement after treatment of atrial fibrillation correlates with heart rate variability.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startNov 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazem Omran, MD, Principal investigator, HDZ NRW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092362
- Sponsor's protocol ID
- HDZNRW-KA-009-HO
- Acronym
- BVAR-Afib
- Status last verified
- Jul 2020
- First submitted
- 21 Mar 2017
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26298305
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beat-to-beat Variability in Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03092362
- Acronym / sponsor ID
- BVAR-Afib / HDZNRW-KA-009-HO
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- persistent atrial fibrillation, Heart rate variability, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Persistent atrial fibrillation
- No previous ablation for atrial fibrillation
- At least 18 years old
- Signed written patient's informed consent
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial fibrillation symptoms
Time frame: 7 days
Whether atrial fibrillation symptoms assessed by Quality-of-Life questionnaires correlates with heart rate variability
2 secondary outcomes
Atrial fibrillation symptoms
Time frame: 7 days
Improvement in 6MWD (6 minutes walk distance)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Background: PubMed 26298305Cygankiewicz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazem Omran, MD principal investigator
HDZ NRW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Atrial Fibrillation, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation symptoms (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.