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

Atrial Fibrillation Clinical Trial

— DanAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04542785
• Other study ID #: REG-078-2019
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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