To test whether an early, comprehensive, rhythm control therapy can prevent adverse cardiovascular outcomes in patients with recent-onset atrial fibrillation (AF) compared to usual care.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A composite of cardiovascular death, stroke / transient ischemic attack (TIA),
and hospitalization due to worsening of heart failure or due to acute coronary
syndrome.
The 1st co-primary outcome parameter is defined as the time to the first
occurrence of a composite of the above mentioned components. The 2nd co-primary
outcome is nights spent in hospital per year.
Secondary outcome
Several secondary outcomes will be assessed in the study population. Key
secondary outcomes: Each of the components of the primary outcome, time to
recurrent AF, cardiovascular hospitalizations, all-cause hospitalizations, left
ventricular function, quality of life, cognitive function, cost of therapy.
These and additional secondary outcome parameters will be assessed in the main
trial and in investigator driven sub-studies.
Assessment of safety: The primary safety outcome comprises all deaths, the
components of the primary efficacy parameter plus other adverse events related
to the study intervention with special emphasis on proarrhythmia and
complications due to interventions.
Background summary
Atrial fibrillation (AF) affects 1-2% of the population in Europe, doubles
death rates, and causes deaths, severe strokes, heart failure, and acute
coronary syndrome. Present management of AF, consisting of antithrombotic
therapy, rate control, and often inconsistently applied rhythm control therapy,
only partially prevents these complications. New, relatively safe
antiarrhythmic agents and catheter-based isolation of the pulmonary veins
provide potentially synergistic novel therapeutic options to maintain sinus
rhythm, but their impact on major cardiovascular outcomes in AF remains
controversial. Furthermore, long-lasting AF induces irreversible atrial damage
and thereby renders sinus rhythm much more difficult to maintain.
EAST prospectively tests the hypothesis that an early, structured rhythm
control therapy based on antiarrhythmic drugs and catheter ablation can prevent
AF-related complications in patients with recent-onset AF when compared to
usual care.
Study objective
To test whether an early, comprehensive, rhythm control therapy can prevent
adverse cardiovascular outcomes in patients with recent-onset atrial
fibrillation (AF) compared to usual care.
Study design
Investigator-driven, Prospective, parallel-group, randomized, open, blinded
outcome assessment (PROBE) parallel-group interventional multi-centre trial.
Phase IV.
Intervention
Patients will be randomized to early therapy or usual care. In the early
therapy group, patients will receive either catheter ablation (usually by
pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early
time point. The initial therapy will be selected by the local investigator.
Upon AF recurrence, both modalities will be combined. Usual care will be
conducted following the current ESC guidelines for AF treatment. In addition to
antithrombotic therapy and therapy of underlying heart disease, usual care
usually consists of an initial attempt to control symptoms by rate control
therapy (bisoprolol, digoxin, digitoxin, metoprolol, verapamil).
Early rhythm control therapy will be guided by ECG monitoring.
All therapies applied in EAST are authority approved and mar-keted modalities.
Study burden and risks
Early, structured rhythm control therapy has the potential to improve prognosis
of AF patients by preventing AF-related cardiovascular complications.
As all treatments in EAST are in-line with clinical practice and recommended by
guidelines, adverse events are expected to occur in similar clinical
manifestations and at a comparable rate as the known adverse events of the
approved therapies applied in the trial.
In light of the safety profile of the employed, established drugs and the
frequency of AF and its possible cardiovascular complications the benefit-risk
assessment turns out to be positive.
Mendelstraße 11 1
Münster 48149
DE
Mendelstraße 11 1
Münster 48149
DE
Listed location countries
Age
Inclusion criteria
1. Recent onset AF, i.e. AF with a known history of <= 1 year prior to randomisation
2. Risk for stroke as evidenced by
EITHER
a) one of the following: age > 75 years, prior stroke or transient ischemic attack (TIA)
OR
b) two of the following: hypertension, diabetes mellitus, left ventricular hypertrophy, age > 65 years, female sex, peripheral artery disease, kidney disease (MDRD stage III or IV), stable heart
failure (NYHA II or LVEF <50%), severe coronary artery disease (previous myocardial infarction, CABG or PCI)
Exclusion criteria
1. prior AF ablation or surgical therapy of AF
2. patients not suitable for rhythm control of AF
3. severe mitral valve stenosis
4. prosthetic mitral valve
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021258-20-NL |
| ClinicalTrials.gov | NCT01288352;ISRCTN04708680 |
| CCMO | NL37017.042.11 |