Clinical trial NCT04542785: Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation Randomised Clinical Trial
Official title: Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation (DanAF) Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation, Persistent
Atrial Fibrillation Chronic
Atrial Fibrillation
Keywords: Rate control
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Hvidovre University Hospital
name: Zealand University Hospital
First posted: 2020-09-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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).
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. Informed consent.
4. Adult (18 years or older).

Exclusion Criteria:

1. No informed consent.
2. Initial heart rate under 80 bpm at rest (assessed via ECG 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

Primary outcomes:
measure: Short Form-36 (SF-36) physical component score
timeFrame: After 1 year
Secondary outcomes:
measure: Days alive outside hospital
timeFrame: After 6 months
measure: Atrial Fibrillation Effect on Quality of Life (AFEQT)
timeFrame: After 1 year
measure: Short Form-36 (SF-36) mental component score
timeFrame: 1 year
measure: Serious adverse events
timeFrame: 1 year
Other outcomes:
measure: All-cause mortality
timeFrame: 1 year
measure: All-cause mortality
timeFrame: 2 year
measure: All-cause mortality
timeFrame: After 3 years
measure: Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest.
timeFrame: 1 year
measure: Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest.
timeFrame: 2 year
measure: Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest.
timeFrame: After 3 years
measure: Cardiac mortality
timeFrame: 1 year
measure: Cardiac mortality
timeFrame: 2 year
measure: Cardiac mortality
timeFrame: After 3 years
measure: Stroke
timeFrame: 1 year
measure: Stroke
timeFrame: 2 year
measure: Stroke
timeFrame: After 3 years
measure: Hospitalisation for worsening of heart failure
timeFrame: 1 year
measure: Hospitalisation for worsening of heart failure
timeFrame: 2 year
measure: Hospitalisation for worsening of heart failure
timeFrame: After 3 years
measure: Number of hospital admissions
timeFrame: 1 year
measure: Number of hospital admissions
timeFrame: 2 year
measure: Number of hospital admissions
timeFrame: After 3 years
measure: Six-minute walking distance
timeFrame: 1 year
measure: Six-minute walking distance
timeFrame: 2 year
measure: Six-minute walking distance
timeFrame: After 3 years
measure: Physical activity measured using a trial accelerometer or similar
timeFrame: 1 year
measure: Physical activity measured using a trial accelerometer or similar
timeFrame: 2 year
measure: Physical activity measured using a trial accelerometer or similar
timeFrame: After 3 years
measure: Presence of sleep apnoea
timeFrame: 1 year
measure: Presence of sleep apnoea
timeFrame: 2 year
measure: Presence of sleep apnoea
timeFrame: After 3 years
measure: Heart rate
timeFrame: 1 year
measure: Heart rate
timeFrame: 2 year
measure: Heart rate
timeFrame: After 3 years
measure: Healthcare costs
timeFrame: 1 year
measure: Healthcare costs
timeFrame: 2 year
measure: Healthcare costs
timeFrame: After 3 years
measure: Various biomarkers
timeFrame: 1 year
measure: Various biomarkers
timeFrame: 2 year
measure: Various biomarkers
timeFrame: After 3 years
measure: Switch to rhythm control strategy
timeFrame: 1 year
measure: Switch to rhythm control strategy
timeFrame: 2 year
measure: Switch to rhythm control strategy
timeFrame: After 3 years
measure: Implantation of a pacemaker or cardioverter-defibrillator
timeFrame: 1 year
measure: Implantation of a pacemaker or cardioverter-defibrillator
timeFrame: 2 year
measure: Implantation of a pacemaker or cardioverter-defibrillator
timeFrame: After 3 years
measure: The questionnaire WorkQ
timeFrame: 1 year
measure: The questionnaire WorkQ
timeFrame: 2 year
measure: The questionnaire WorkQ
timeFrame: After 3 years
measure: Echocardiography - Left ventricle dimensions
timeFrame: After 1 year
measure: Echocardiography - Left ventricle dimensions
timeFrame: After 2 years
measure: Echocardiography - Left ventricle dimensions
timeFrame: After 3 years
measure: Echocardiography - systolic and diastolic function
timeFrame: After 1 year
measure: Echocardiography - systolic and diastolic function
timeFrame: After 2 years
measure: Echocardiography - systolic and diastolic function
timeFrame: After 3 years
measure: Echocardiography - Right ventricle dimension
timeFrame: After 1 year
measure: Echocardiography - Right ventricle dimension
timeFrame: After 2 years
measure: Echocardiography - Right ventricle dimension
timeFrame: After 3 years
measure: Echocardiography - Atrial dimensions
timeFrame: After 1 year
measure: Echocardiography - Atrial dimensions
timeFrame: After 2 years
measure: Echocardiography - Atrial dimensions
timeFrame: After 3 years
measure: Echocardiography - pulmonary pressure
timeFrame: After 1 year
measure: Echocardiography - pulmonary pressure
timeFrame: After 2 years
measure: Echocardiography - pulmonary pressure
timeFrame: After 3 years
measure: Short Form-36 (SF-36) physical component score
timeFrame: After 2 years
measure: Short Form-36 (SF-36) physical component score
timeFrame: After 3 years
measure: Days alive outside hospital
timeFrame: After 1 year
measure: Days alive outside hospital
timeFrame: After 2 years
measure: Days alive outside hospital
timeFrame: After 3 years
measure: Atrial Fibrillation Effect on Quality of Life (AFEQT)
timeFrame: After 2 years
measure: Atrial Fibrillation Effect on Quality of Life (AFEQT)
timeFrame: After 3 years
measure: Short Form-36 (SF-36) mental component score
timeFrame: After 2 years
measure: Short Form-36 (SF-36) mental component score
timeFrame: After 3 years
measure: Serious adverse events
timeFrame: After 2 years
measure: Serious adverse events
timeFrame: After 3 years
Locations:
city: Holbæk
country: Denmark
facility: Holbæk Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital - Roskilde
Study officials:
affiliation: Holbaek University Hospital/University of Southern Denmark
name: Joshua Feinberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.