Atrial fibrillation, stroke, heart failure, myocardial infarction, cognitive dysfunction MedDRA version: 17.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders MedDRA version: 17.1 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders MedDRA version: 17.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders M
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Kompetenznetz Vorhofflimmern e.V. (AFNET)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Recent-onset AF (= 1 year prior to enrolment) 2. At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 s. 3. EITHER one of the following: * age > 75 years or * prior stroke or transient ischemic attack OR two of the following: * age > 65 years, * female sex, * arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg), * diabetes mellitus (treated by drugs or insulin) or impaired glucose tolerance 30 * severe coronary artery disease (previous myocardial infarction, CABG or PCI) * Stable heart failure (NYHA II or LVEF =65 years) yes F.1.3.1 Number of subjects for this age range 2000
Exclusion criteria
Exclusion criteria: 1. Any disease that limits life expectancy to less than 1 year. 2. Participation in another clinical trial, either within the past two months or ongoing 3. Previous participation in the EAST trial. 4. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized. 5. Breastfeeding women. 6. Drug abuse. 7. Prior AF ablation or surgical therapy of AF. 8. Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone. 9. Patients not suitable for rhythm control of AF. 10. Severe mitral valve stenosis. 11. Prosthetic mitral valve. 12. Clinically relevant hepatic dysfunction requiring specific therapy. 13. Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled. 14. Severe renal dysfunction (stage V, requiring or almost requiring dialysis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether an early and comprehensive rhythm control therapy can prevent adverse cardiovascular outcomes in patients with atrial fibrillation (AF) compared to usual care.;Secondary Objective: n.a.;Primary end point(s): A composite of cardiovascular death, stroke, transitoric ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome. The first co-primary outcome parameter is defined as the time to the first occurrence of a composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary. The second co-primary outcome parameter is nights spent in hospital per year. ;Timepoint(s) of evaluation of this end point: A first interim analysis is to be performed when the first 171 events in the 1st co-primary outcome have been observed. If the assumptions are met, this will happen 32 months after the first patient was randomized. The second interim analysis is to be performed when the first 343 events in the 1st co-primary outcome have been observed (approximately 47 months after the first patient was randomized). The third interim analysis is to be performed when the first 514 events have been observed (approximately 59 (11) months after the first (last) patient was randomized). The final analysis is to be performed when 685 events have been observed. If the assumptions are met, this will happen 72 (24) months after the first (last) patient was randomized. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Cardiovascular death 2. stroke 3. worsening of heart failure assessed by hospitalizations 4. acute coronary syndrome assessed by hospitalizations 5. time to recurrent atrial fibrillation 6. cardiovascular hospitalisations 7. all-cause hospitalisations 8. left ventricular function assessed by transthoracic echocardiography 9. quality of life changes assessed by EQ-5D and SF-12 10. cognitive function assessed by MoCA;Timepoint(s) of evaluation of this end point: Evaluation of secondary end points no. 1-7 at the end of the trial (i.e. after 6 years). Evaluation of secondary end points no. 8-10 at month 24 after randomisation. | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Contacts
Public ContactClinical Trials Information
Kompetenznetz Vorhofflimmern e.V. (AFNET)
Outcome results
None listed