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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04542785
Other study ID # REG-078-2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 31, 2021
Est. completion date March 2, 2026

Study information

Verified date March 2022
Source Holbaek Sygehus
Contact Joshua Feinberg, MD
Phone +45 59484530
Email jorf@regionsjaelland.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date March 2, 2026
Est. primary completion date March 2, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Rate 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.

Locations

Country Name City State
Denmark Holbæk Hospital Holbæk
Denmark Hvidovre University Hospital Hvidovre
Denmark Odense University Hospital Odense
Denmark Zealand University Hospital - Roskilde Roskilde

Sponsors (4)

Lead Sponsor Collaborator
Holbaek Sygehus Hvidovre University Hospital, Odense University Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other All-cause mortality Mortality regardless of cause. 1 year
Other All-cause mortality Mortality regardless of cause. 2 year
Other All-cause mortality Mortality regardless of cause. After 3 years
Other Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest. 1 year
Other Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest. 2 year
Other Composite of all-cause mortality, stroke, myocardial infarction and cardiac arrest. After 3 years
Other Cardiac mortality 1 year
Other Cardiac mortality 2 year
Other Cardiac mortality After 3 years
Other Stroke ICD-10 codes I60-I63. 1 year
Other Stroke ICD-10 codes I60-I63. 2 year
Other Stroke ICD-10 codes I60-I63. After 3 years
Other Hospitalisation for worsening of heart failure 1 year
Other Hospitalisation for worsening of heart failure 2 year
Other Hospitalisation for worsening of heart failure After 3 years
Other Number of hospital admissions 1 year
Other Number of hospital admissions 2 year
Other Number of hospital admissions After 3 years
Other Six-minute walking distance 1 year
Other Six-minute walking distance 2 year
Other Six-minute walking distance After 3 years
Other Physical activity measured using a trial accelerometer or similar 1 year
Other Physical activity measured using a trial accelerometer or similar 2 year
Other Physical activity measured using a trial accelerometer or similar After 3 years
Other Presence of sleep apnoea 1 year
Other Presence of sleep apnoea 2 year
Other Presence of sleep apnoea After 3 years
Other Heart rate 1 year
Other Heart rate 2 year
Other Heart rate After 3 years
Other Healthcare costs 1 year
Other Healthcare costs 2 year
Other Healthcare costs After 3 years
Other Various biomarkers 1 year
Other Various biomarkers 2 year
Other Various biomarkers After 3 years
Other Switch to rhythm control strategy 1 year
Other Switch to rhythm control strategy 2 year
Other Switch to rhythm control strategy After 3 years
Other Implantation of a pacemaker or cardioverter-defibrillator 1 year
Other Implantation of a pacemaker or cardioverter-defibrillator 2 year
Other Implantation of a pacemaker or cardioverter-defibrillator After 3 years
Other The questionnaire WorkQ 1 year
Other The questionnaire WorkQ 2 year
Other The questionnaire WorkQ After 3 years
Other Echocardiography - Left ventricle dimensions After 1 year
Other Echocardiography - Left ventricle dimensions After 2 years
Other Echocardiography - Left ventricle dimensions After 3 years
Other Echocardiography - systolic and diastolic function After 1 year
Other Echocardiography - systolic and diastolic function After 2 years
Other Echocardiography - systolic and diastolic function After 3 years
Other Echocardiography - Right ventricle dimension After 1 year
Other Echocardiography - Right ventricle dimension After 2 years
Other Echocardiography - Right ventricle dimension After 3 years
Other Echocardiography - Atrial dimensions After 1 year
Other Echocardiography - Atrial dimensions After 2 years
Other Echocardiography - Atrial dimensions After 3 years
Other Echocardiography - pulmonary pressure After 1 year
Other Echocardiography - pulmonary pressure After 2 years
Other Echocardiography - pulmonary pressure After 3 years
Other Short Form-36 (SF-36) physical component score After 2 years
Other Short Form-36 (SF-36) physical component score After 3 years
Other Days alive outside hospital After 1 year
Other Days alive outside hospital After 2 years
Other Days alive outside hospital After 3 years
Other Atrial Fibrillation Effect on Quality of Life (AFEQT) After 2 years
Other Atrial Fibrillation Effect on Quality of Life (AFEQT) After 3 years
Other Short Form-36 (SF-36) mental component score After 2 years
Other Short Form-36 (SF-36) mental component score After 3 years
Other Serious adverse events After 2 years
Other Serious adverse events After 3 years
Primary Short Form-36 (SF-36) physical component score After 1 year
Secondary Days alive outside hospital After 6 months
Secondary Atrial Fibrillation Effect on Quality of Life (AFEQT) After 1 year
Secondary Short Form-36 (SF-36) mental component score 1 year
Secondary Serious adverse events 1 year
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