drugset / Trial / NCT02391337

Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)

NCT02391337

Phase 4 Completed 161 enrolled University of Birmingham
RandomizedParallel-groupOpen-labelTreatment

Summary

Atrial fibrillation is a common heart rhythm disturbance, causing important discomfort for patients, a high risk of stroke, frequent hospital admissions and a two-fold increase in death. The number of patients with this condition are expected to double in the next 20 years. Medications to control heart-rate are used in the majority of patients, although the choice of agent is often guided by local preference rather than evidence from controlled trials. Despite the fact that patients with atrial fibrillation have high rates of other cardiac conditions such as heart failure, clinicians have insufficient evidence to personalise the use of different therapies. This feasibility study will allow us to develop a range of methods that can characterise patients according to the pumping and relaxing function of the heart, the burden of symptoms and to identify new blood markers. In this way, the investigators hope to improve clinical practice guidelines, allowing doctors to prescribe appropriate treatments for the right patients. The research will be focused around a randomised trial of two medication strategies, providing much-needed data on the comparison of digoxin and beta-blockers (two commonly-used drugs in patients with atrial fibrillation). It will also allow us to identify the best way to record patient-reported quality of life and develop robust techniques to determine heart function using non-invasive imaging, facilitating the conduct of a large-scale clinical trial. The key objectives of the research programme are to define the optimal medications for patients with atrial fibrillation and identify the most valid, reproducible and cost-effective methods to examine patients. The ultimate aim of the project is to improve clinical outcomes in atrial fibrillation, benefiting patients, the National Health Service and the global community.

Timeline

Start
2016-12-20
Primary completion
2019-04-15
Completion
2019-09-16

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bisoprolol Other / unclassified 15 mg Oral
Comparator Digoxin Other / unclassified 62.5 ug Oral
Comparator Digoxin Other / unclassified 125 ug Oral

Indications