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2017 ; 7
(7
): e015099
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A review of rate control in atrial fibrillation, and the rationale and protocol
for the RATE-AF trial
#MMPMID28729311
Kotecha D
; Calvert M
; Deeks JJ
; Griffith M
; Kirchhof P
; Lip GY
; Mehta S
; Slinn G
; Stanbury M
; Steeds RP
; Townend JN
BMJ Open
2017[Jul]; 7
(7
): e015099
PMID28729311
show ga
BACKGROUND AND OBJECTIVE: Atrial fibrillation (AF) is common and causes impaired
quality of life, an increased risk of stroke and death as well as frequent
hospital admissions. The majority of patients with AF require control of heart
rate. In this article , we summarise the limited evidence from clinical trials
that guides prescription, and present the rationale and protocol for a new
randomised trial. As rate control has not yet been shown to reduce mortality,
there is a clear need to compare the impact of therapy on quality of life,
cardiac function and exercise capacity. Such a trial should concentrate on the
long-term effects of treatment in the largest proportion of patients with AF,
those with symptomatic permanent AF, with the aim of improving patient
well-being. DESIGN AND INTERVENTION: The RAte control Therapy Evaluation in
permanent Atrial Fibrillation (RATE-AF) trial will enrol 160 participants with a
prospective, randomised, open-label, blinded end point design comparing initial
rate control with digoxin or bisoprolol. This will be the first head-to-head
randomised trial of digoxin and beta-blockers in AF. PARTICIPANTS: Recruited
patients will be aged ΓΆΒ?Β¥60 years with permanent AF and symptoms of
breathlessness (equivalent to New York Heart Association class II or above), with
few exclusion criteria to maximise generalisability to routine clinical practice.
OUTCOME MEASURES: The primary outcome is patient-reported quality of life, with
secondary outcomes including echocardiographic ventricular function, exercise
capacity and biomarkers of cellular and clinical response. Follow-up will occur
at 6 and 12 months, with feasibility components to inform the design of a future
trial powered to detect a difference in hospital admission. The RATE-AF trial
will underpin an integrated approach to management including biomarkers,
functions and symptoms that will guide future research into optimal, personalised
rate control in patients with AF. ETHICS AND DISSEMINATION: East Midlands-Derby
Research Ethics Committee (16/EM/0178); peer-reviewed publications. TRIAL
REGISTRATION: Clinicaltrials.gov: NCT02391337; ISRCTN: 95259705. Pre-results.