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RecruitingNCT04542785DanAFUpdated Mar 16, 2022

Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation Randomised Clinical Trial

An interventional study of Rate control in Atrial Fibrillation, Persistent, Atrial Fibrillation Chronic and Atrial Fibrillation, sponsored by Holbaek Sygehus. Recruiting at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.

Sponsored by Holbaek Sygehus · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2021; still recruiting 5 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Atrial Fibrillation, Persistent
  • Atrial Fibrillation Chronic
  • Atrial Fibrillation

Browse trials for

Keywords

  • Rate control
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 350 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Holbaek Sygehus is the lead sponsor of 27 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants with atrial fibrillation ( 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).
  2. 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).
  3. .
  4. Adult (18 years or older).

Exclusion criteria

Exclusion Criteria:

  1. No .
  2. Initial heart rate under 80 bpm at rest (assessed via before randomisation).
  3. Less than 3 weeks of anticoagulation with new oral anticoagulants or 4 weeks with efficient warfarin if indicated.
  4. 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.
  5. Participants who are haemodynamically unstable and therefore require immediate electrical cardioversion
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
350 participants (estimated)

Study arms

  • Experimental
    Lenient rate control

    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.

    Other: Rate control

  • Active comparator
    Strict rate control

    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.

    Other: Rate control

Interventions

  • OtherRate control

    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.

06

What researchers measure

Primary outcomes

  1. Short Form-36 (SF-36) physical component score

    Time frame: After 1 year

Secondary outcomes

  1. Days alive outside hospital

    Time frame: After 6 months

  2. Atrial Fibrillation Effect on Quality of Life (AFEQT)

    Time frame: After 1 year

  3. Short Form-36 (SF-36) mental component score

    Time frame: 1 year

  4. Serious adverse events

    Time frame: 1 year

Other outcomes

  1. All-cause mortality

    Mortality regardless of cause.

    Time frame: 1 year

  2. All-cause mortality

    Mortality regardless of cause.

    Time frame: 2 year

  3. All-cause mortality

    Mortality regardless of cause.

    Time frame: After 3 years

  4. Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest.

    Time frame: 1 year

  5. Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest.

    Time frame: 2 year

  6. Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest.

    Time frame: After 3 years

  7. Cardiac mortality

    Time frame: 1 year

  8. Cardiac mortality

    Time frame: 2 year

  9. Cardiac mortality

    Time frame: After 3 years

  10. Stroke

    ICD-10 codes I60-I63.

    Time frame: 1 year

  11. Stroke

    ICD-10 codes I60-I63.

    Time frame: 2 year

  12. Stroke

    ICD-10 codes I60-I63.

    Time frame: After 3 years

  13. Hospitalisation for worsening of heart failure

    Time frame: 1 year

  14. Hospitalisation for worsening of heart failure

    Time frame: 2 year

  15. Hospitalisation for worsening of heart failure

    Time frame: After 3 years

  16. Number of hospital admissions

    Time frame: 1 year

  17. Number of hospital admissions

    Time frame: 2 year

  18. Number of hospital admissions

    Time frame: After 3 years

  19. Six-minute walking distance

    Time frame: 1 year

  20. Six-minute walking distance

    Time frame: 2 year

  21. Six-minute walking distance

    Time frame: After 3 years

  22. Physical activity measured using a trial accelerometer or similar

    Time frame: 1 year

  23. Physical activity measured using a trial accelerometer or similar

    Time frame: 2 year

  24. Physical activity measured using a trial accelerometer or similar

    Time frame: After 3 years

  25. Presence of sleep apnoea

    Time frame: 1 year

  26. Presence of sleep apnoea

    Time frame: 2 year

  27. Presence of sleep apnoea

    Time frame: After 3 years

  28. Heart rate

    Time frame: 1 year

  29. Heart rate

    Time frame: 2 year

  30. Heart rate

    Time frame: After 3 years

  31. Healthcare costs

    Time frame: 1 year

  32. Healthcare costs

    Time frame: 2 year

  33. Healthcare costs

    Time frame: After 3 years

  34. Various biomarkers

    Time frame: 1 year

  35. Various biomarkers

    Time frame: 2 year

  36. Various biomarkers

    Time frame: After 3 years

  37. Switch to rhythm control strategy

    Time frame: 1 year

  38. Switch to rhythm control strategy

    Time frame: 2 year

  39. Switch to rhythm control strategy

    Time frame: After 3 years

  40. Implantation of a pacemaker or cardioverter-defibrillator

    Time frame: 1 year

  41. Implantation of a pacemaker or cardioverter-defibrillator

    Time frame: 2 year

  42. Implantation of a pacemaker or cardioverter-defibrillator

    Time frame: After 3 years

  43. The questionnaire WorkQ

    Time frame: 1 year

  44. The questionnaire WorkQ

    Time frame: 2 year

  45. The questionnaire WorkQ

    Time frame: After 3 years

  46. Echocardiography - Left ventricle dimensions

    Time frame: After 1 year

  47. Echocardiography - Left ventricle dimensions

    Time frame: After 2 years

  48. Echocardiography - Left ventricle dimensions

    Time frame: After 3 years

  49. Echocardiography - systolic and diastolic function

    Time frame: After 1 year

  50. Echocardiography - systolic and diastolic function

    Time frame: After 2 years

  51. Echocardiography - systolic and diastolic function

    Time frame: After 3 years

  52. Echocardiography - Right ventricle dimension

    Time frame: After 1 year

  53. Echocardiography - Right ventricle dimension

    Time frame: After 2 years

  54. Echocardiography - Right ventricle dimension

    Time frame: After 3 years

  55. Echocardiography - Atrial dimensions

    Time frame: After 1 year

  56. Echocardiography - Atrial dimensions

    Time frame: After 2 years

  57. Echocardiography - Atrial dimensions

    Time frame: After 3 years

  58. Echocardiography - pulmonary pressure

    Time frame: After 1 year

  59. Echocardiography - pulmonary pressure

    Time frame: After 2 years

  60. Echocardiography - pulmonary pressure

    Time frame: After 3 years

  61. Short Form-36 (SF-36) physical component score

    Time frame: After 2 years

  62. Short Form-36 (SF-36) physical component score

    Time frame: After 3 years

  63. Days alive outside hospital

    Time frame: After 1 year

  64. Days alive outside hospital

    Time frame: After 2 years

  65. Days alive outside hospital

    Time frame: After 3 years

  66. Atrial Fibrillation Effect on Quality of Life (AFEQT)

    Time frame: After 2 years

  67. Atrial Fibrillation Effect on Quality of Life (AFEQT)

    Time frame: After 3 years

  68. Short Form-36 (SF-36) mental component score

    Time frame: After 2 years

  69. Short Form-36 (SF-36) mental component score

    Time frame: After 3 years

  70. Serious adverse events

    Time frame: After 2 years

  71. Serious adverse events

    Time frame: After 3 years

07

Study locations

1 of 4 sites recruiting
  • Holbæk Hospital
    Holbæk, 4300, Denmark
    Recruiting
    • Joshua B Feinberg, MD · Contact004550587215
    • Ilan Raymond, MD · Principal investigator
  • Hvidovre University Hospital
    Hvidovre, 2650, Denmark
    Not yet recruiting
    • Ulrik Dixen, Prof · Principal investigator
  • Odense University Hospital
    Odense, 5000, Denmark
    Not yet recruiting
    • Axel Brandes, prof. · Principal investigator
  • Zealand University Hospital - Roskilde
    Roskilde, 4000, Denmark
    Not yet recruiting
    • Ole D Pedersen, DMSc · Principal investigator
    • Uffe Gang, MD · Sub investigator
08

References and documents

Publications

  • Feinberg 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 ↗

Individual participant data

Plan to share: Yes — We will share anonymised data in a data repository.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Not possible to describe yet but will be made available within a timely manner after publication of results.

Access criteria: Sharing will abide by the General Data Protection Regulation and the Danish data protections laws.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04542785
Lead sponsor
Holbaek Sygehus
Collaborators
Odense University Hospital, Hvidovre University Hospital, Zealand University Hospital
Responsible party
Joshua Rose-Hansen Feinberg (MD, Holbaek Sygehus) — Principal investigator
First posted
Sep 9, 2020
Start date
Mar 31, 2021
Primary completion
Mar 2, 2026 (estimated)
Completion
Mar 2, 2026 (estimated)
Last update
Mar 16, 2022

Study contacts

Joshua Feinberg, MD
Contact
jorf@regionsjaelland.dk
+45 59484530
Joshua Feinberg, MD
principal investigator · Holbaek University Hospital/University of Southern Denmark

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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