Atrial Fibrillation, PersistentDanAFNCT04542785
Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation Randomised Clinical Trial
A study of Atrial Fibrillation, Persistent and Atrial Fibrillation Chronic, run by Holbaek Sygehus at 4 sites in Denmark.
Trial summary
Atrial fibrillation is the most common heart arrhythmia with a prevalence of approximately 2% in the western world. Atrial fibrillation is associated with an increased risk of death and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent, Atrial Fibrillation Chronic, Atrial Fibrillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 4 sitesDenmark
- Study dates
- 31 Mar 2021to 2 Mar 2026
- Phase
- Interventional
- 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
Who may be able to join
- Participants with atrial fibrillation (ECG confirmed and diagnosed by the treatment provider) who at inclusion have either persistent (defined as atrial fibrillation for more than 7days) or permanent atrial fibrillation (only rate control is considered going forward).
- Rate control must be accepted as being the primary management strategy going forward. Consideration towards whether rhythm control is more appropriate must be considered, especially given the results of the Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST).
- Informed consent.
- Adult (18 years or older).
Who cannot join
- No informed consent.
- Initial heart rate under 80 bpm at rest (assessed via ECG before randomisation).
- Less than 3 weeks of anticoagulation with new oral anticoagulants or 4 weeks with efficient warfarin if indicated.
- If the treating physician deems that the participant is not fit to be randomised into both groups based on an individual assessment. Such a decision will be made before randomisation by the treating physician. This can e.g. be participants dependent on a high ventricular rate to maintain a sufficient cardiac output. Such participants could be participants with heart failure, participants with a hemodynamically significant valve dysfunction, or severely dehydrated participants.
- Participants who are haemodynamically unstable and therefore require immediate electrical cardioversion
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites, 4 recruiting
- Recruiting
Holbæk Hospital
Holbæk, 4300
Joshua B Feinberg, MD, 004550587215
Ilan Raymond, MD
- Not yet recruiting
Hvidovre University Hospital
Hvidovre, 2650
Ulrik Dixen, Prof
- Not yet recruiting
Odense University Hospital
Odense, 5000
Axel Brandes, prof.
- Not yet recruiting
Zealand University Hospital - Roskilde
Roskilde, 4000
Ole D Pedersen, DMSc
Uffe Gang, MD
About this study
Official title: Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation (DanAF) Randomised Clinical Trial
Atrial fibrillation is the most common heart arrhythmia with a prevalence of approximately 2% in the western world. Atrial fibrillation is associated with an increased risk of death and morbidity. The comparable effects of a lenient rate control strategy and a strict rate control strategy in patients with atrial fibrillation are uncertain and only one trial has assessed this previously in patients with permanent atrial fibrillation.
The investigators will therefore undertake a randomised, superiority trial at four hospitals in Denmark.
- Being tested
- Rate control
- Keywords
- Rate control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate controlOther
Treatment will be provided according to current guidelines and as such the algorithm for treatment will be differentiated based on the status of left ventricular ejection fraction. For participants with reduced left ventricular ejection fraction, beta-blockers (metoprolol and bisoprolol) will be the primary therapy. Secondary therapies may include digoxin or amiodarone. For participants with preserved left ventricular ejection fraction, the primary therapy will be beta-blockers (metoprolol and bisoprolol) or non-dihydropyridine calcium-channel blockers (verapamil) with secondary therapy consisting of digoxin or amiodarone. Pacing therapies, alone or with atrioventricular node ablation, are utilised as indicated in the view of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Lenient rate control | Experimental | Treating physicians will target a resting heart rate between 80 and 110 beats per minute on a 12-lead resting ECG measured over 1 minute after 5 minutes of rest. Receives: Other: Rate control |
| Strict rate control | Active comparator | Treating physicians will target a resting heart rate a mean resting heart rate < 80 bpm on a 12-lead resting ECG measured over 1 minute after 5 minutes of rest. Receives: Other: Rate control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form-36 (SF-36) physical component score
Measured: After 1 year
Secondary outcomes (4)
Days alive outside hospital
Measured: After 6 months
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Measured: After 1 year
Short Form-36 (SF-36) mental component score
Measured: 1 year
Serious adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start31 Mar 2021
- Primary completion2 Mar 2026 (estimated)
- Study completion2 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation, PersistentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Hvidovre University Hospital, Zealand University Hospital
- Responsible party
- Principal investigator, Joshua Rose-Hansen Feinberg, Holbaek Sygehus
- Investigators
- Joshua Feinberg, MD, Principal investigator, Holbaek University Hospital/University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542785
- Sponsor's protocol ID
- REG-078-2019
- Acronym
- DanAF
- Status last verified
- Mar 2022
- First submitted
- 26 Aug 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share anonymised data in a data repository.
Publications
Cold IM, Feinberg JB, Brandes A, Davidsen U, Dixen U, Dominguez H, Gang UJO, Gluud C, Hadad R, Kristensen KE, van Le DT, Nielsen EE, Olsen MH, Pedersen OD, Raymond IE, Sajadieh A, Soja AMB, Jakobsen JC. Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial. Trials. 2023 Apr 1;24(1):250. doi: 10.1186/s13063-023-07247-7.
PubMed 37005636Feinberg JB, Olsen MH, Brandes A, Raymond L, Nielsen WB, Nielsen EE, Stensgaard-Hansen F, Dixen U, Pedersen OD, Gang UJO, Gluud C, Jakobsen JC. Lenient rate control versus strict rate control for atrial fibrillation: a protocol for the Danish Atrial Fibrillation (DanAF) randomised clinical trial. BMJ Open. 2021 Mar 31;11(3):e044744. doi: 10.1136/bmjopen-2020-044744.
PubMed 33789853
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation (DanAF) Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04542785
- Acronym / sponsor ID
- DanAF / REG-078-2019
- Keywords
- Rate control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Odense University Hospital, Hvidovre University Hospital, Zealand University Hospital
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 9 Sep 2020 (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.
Atrial fibrillation is the most common heart arrhythmia with a prevalence of approximately 2% in the western world. Atrial fibrillation is associated with an increased risk of death and morbidity. The comparable effects of a lenient rate control strategy and a strict rate control strategy in patients with atrial fibrillation are uncertain and only one trial has assessed this previously in patients with permanent atrial fibrillation.
The investigators will therefore undertake a randomised, superiority trial at four hospitals in Denmark.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenient rate control | Experimental | Other: Rate controlTreating physicians will target a resting heart rate between 80 and 110 beats per minute on a 12-lead resting ECG measured over 1 minute after 5 minutes of rest. |
| Strict rate control | Active comparator | Other: Rate controlTreating physicians will target a resting heart rate a mean resting heart rate < 80 bpm on a 12-lead resting ECG measured over 1 minute after 5 minutes of rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with atrial fibrillation (ECG confirmed and diagnosed by the treatment provider) who at inclusion have either persistent (defined as atrial fibrillation for more than 7days) or permanent atrial fibrillation (only rate control is considered going forward).
- Rate control must be accepted as being the primary management strategy going forward. Consideration towards whether rhythm control is more appropriate must be considered, especially given the results of the Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST).
- Informed consent.
- Adult (18 years or older).
Key exclusion criteria (5 listed)
- No informed consent.
- Initial heart rate under 80 bpm at rest (assessed via ECG before randomisation).
- Less than 3 weeks of anticoagulation with new oral anticoagulants or 4 weeks with efficient warfarin if indicated.
- If the treating physician deems that the participant is not fit to be randomised into both groups based on an individual assessment. Such a decision will be made before randomisation by the treating physician. This can e.g. be participants dependent on a high ventricular rate to maintain a sufficient cardiac output. Such participants could be participants with heart failure, participants with a hemodynamically significant valve dysfunction, or severely dehydrated participants.
- Participants who are haemodynamically unstable and therefore require immediate electrical cardioversion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rate controlTreatment will be provided according to current guidelines and as such the algorithm for treatment will be differentiated based on the status of left ventricular ejection fraction. For participants with reduced left ventricular ejection fraction, beta-blockers (metoprolol and bisoprolol) will be the primary therapy. Secondary therapies may include digoxin or amiodarone. For participants with preserved left ventricular ejection fraction, the primary therapy will be beta-blockers (metoprolol and bisoprolol) or non-dihydropyridine calcium-channel blockers (verapamil) with secondary therapy consisting of digoxin or amiodarone. Pacing therapies, alone or with atrioventricular node ablation, are utilised as indicated in the view of the treating physician. | Other | Lenient rate control, Strict rate control |
Primary outcome
Short Form-36 (SF-36) physical component score
Time frame: After 1 year
4 secondary outcomes
Days alive outside hospital
Time frame: After 6 months
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Time frame: After 1 year
Short Form-36 (SF-36) mental component score
Time frame: 1 year
Serious adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 37005636Cold IM, Feinberg JB, Brandes A, Davidsen U, Dixen U, Dominguez H, Gang UJO, Gluud C, Hadad R, Kristensen KE, van Le DT, Nielsen EE, Olsen MH, Pedersen OD, Raymond IE, Sajadieh A, Soja AMB, Jakobsen JC. Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial. Trials. 2023 Apr 1;24(1):250. doi: 10.1186/s13063-023-07247-7.
- Derived from this study: PubMed 33789853Feinberg JB, Olsen MH, Brandes A, Raymond L, Nielsen WB, Nielsen EE, Stensgaard-Hansen F, Dixen U, Pedersen OD, Gang UJO, Gluud C, Jakobsen JC. Lenient rate control versus strict rate control for atrial fibrillation: a protocol for the Danish Atrial Fibrillation (DanAF) randomised clinical trial. BMJ Open. 2021 Mar 31;11(3):e044744. doi: 10.1136/bmjopen-2020-044744.
- Individual participant dataSharing planned: Yes. We will share anonymised data in a data repository.
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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.
Joshua Feinberg, MD principal investigator
Holbaek University Hospital/University of Southern Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Atrial Fibrillation, Persistent and Atrial Fibrillation Chronic, run by Holbaek Sygehus at 4 sites in Denmark.
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 5 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Feinberg, MD (+45 59484530, jorf@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form-36 (SF-36) physical component score (time frame: After 1 year). 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 NCT04542785, which also lists 2 linked publications.
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 16 Mar 2022.