A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial

Abstract

Background and objectiveAtrial 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 interventionThe 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.ParticipantsRecruited patients will be aged ≥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 measuresThe 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 disseminationEast Midlands-Derby Research Ethics Committee (16/EM/0178); peer-reviewed publications.Trial registrationClinicaltrials.gov: NCT02391337; ISRCTN: 95259705. Pre-results.

European Society of Cardiology smartphone and tablet applications for patients with atrial fibrillation and their health care providers

“…46 The text was then edited by a team of patient representatives with AF (funded through a UK National Institute of Health Research grant on improving patient outcomes in AF). 47 The patient app will also present information on individual stroke risk and provide a personal health record and symptom diary. Patients are asked to fill in sections about relevant previous health issues, which can facilitate consultation when shared with their health care professional(s).…”

Value of speckle tracking echocardiography for prediction of stroke risk in atrial fibrillation: Time to spare a stare outside the box?

“…Although there is no consensus about this, a targeted heart rate control has been reported to have led to normal sinus rhythm at 1 year . A British prospective study is in progress to address the matter. The mean heart rate in the LAAT group was higher in the study by Kupczynska et al .…”

Importance and Assessment of Quality of Life in Symptomatic Permanent Atrial Fibrillation: Patient Focus Groups from the RATE-AF Trial

“…The trial is the first to directly compare longer-term heart rate con-trol using digoxin and beta-blocker therapy in this patient group (clinicaltrials.gov: NCT02391337, ISRCTN: 95259705, and Eu-draCT: 2015-005043-13). The rationale and design of the study have previously been described [7]; in brief, the trial was embedded within the UK National Health Service (NHS), with minimal selection criteria to reflect routine clinical care. Patients were aged 60 years or older, with permanent AF, in need of rate control, and breathlessness equivalent to at least New York Heart Association (NYHA) class II.…”

“…Three validated QoL questionnaires were used in the RATE-AF trial [7]. AF-specific QoL was assessed using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire [10].…”