Atrial Fibrillation, Persistent, Atrial Fibrillation Chronic, Atrial Fibrillation
Conditions
Keywords
Rate control
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.
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.
Sponsors
Odense University Hospital
Hvidovre University Hospital
Zealand University Hospital
Holbaek Sygehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcome assessors will be blinded. Participants will not be informed of the heart rate target or actual heart rate. Treatment providers managing the heart rate target will not be blinded as the intervention requires information of the heart rate. Other treatment providers will not be informed of the heart rate target.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short Form-36 (SF-36) physical component score | After 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Days alive outside hospital | After 6 months |
| Atrial Fibrillation Effect on Quality of Life (AFEQT) | After 1 year |
| Short Form-36 (SF-36) mental component score | 1 year |
| Serious adverse events | 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Days alive outside hospital | After 1 year | — |
| Switch to rhythm control strategy | 1 year | — |
| Implantation of a pacemaker or cardioverter-defibrillator | 1 year | — |
| The questionnaire WorkQ | 1 year | — |
| Echocardiography - Left ventricle dimensions | After 1 year | — |
| All-cause mortality | 1 year | Mortality regardless of cause. |
| Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest. | 1 year | — |
| Cardiac mortality | 1 year | — |
| Stroke | 1 year | ICD-10 codes I60-I63. |
| Hospitalisation for worsening of heart failure | 1 year | — |
| Echocardiography - systolic and diastolic function | After 1 year | — |
| Six-minute walking distance | 1 year | — |
| Physical activity measured using a trial accelerometer or similar | 1 year | — |
| Presence of sleep apnoea | 1 year | — |
| Heart rate | 1 year | — |
| Healthcare costs | 1 year | — |
| Various biomarkers | 1 year | — |
| Atrial Fibrillation Effect on Quality of Life (AFEQT) | After 2 years | — |
| Short Form-36 (SF-36) mental component score | After 2 years | — |
| Serious adverse events | After 2 years | — |
| Number of hospital admissions | 1 year | — |
| Echocardiography - Right ventricle dimension | After 1 year | — |
| Echocardiography - Atrial dimensions | After 1 year | — |
| Echocardiography - pulmonary pressure | After 1 year | — |
| Short Form-36 (SF-36) physical component score | After 2 years | — |
Countries
Denmark
Contacts
Primary ContactJoshua Feinberg, MD
Outcome results
None listed