RATE-AF

  • Research type

    Research Study

  • Full title

    Evaluating different rate control therapies in permanent atrial fibrillation: A prospective, randomised, open-label, blinded endpoint study comparing digoxin and beta-blockers as initial rate control therapy. RAte control Therapy Evaluation in permanent Atrial Fibrialltion: RATE-AF

  • IRAS ID

    191437

  • Contact name

    Dipak Kotecha

  • Contact email

    d.kotecha@bham.ac.uk

  • Eudract number

    2015-005043-13

  • Clinicaltrials.gov Identifier

    NCT02391337

  • Duration of Study in the UK

    2 years, 5 months, 1 days

  • Research summary

    Atrial fibrillation (AF) is a common heart condition that causes an irregular and often rapid heart rate. The lifetime risk of developing AF in adults is 1 in 4 and we can expect twice as many people to have this disease over the next 20 years. Patients are typically elderly and often have a number of other medical conditions, including high blood pressure and heart failure. In addition, AF is a common cause of stroke, hospital admissions and early death, and leads to reduced quality of life. An important part of AF treatment is the control of heart rate, however we currently lack evidence as to which medication is the best for rate-control and whether we can improve quality of life or heart function.

    The RATE-AF trial is designed to compare two strategies of rate-control, based either on initial treatment with digoxin or beta-blockers. 160 patients with AF in need of rate-control therapy will be randomly assigned to these two treatments which are frequently used in clinical practice. Recruitment will occur through one NHS Acute Trust, with additional support through another Acute NHS Trust and Primary Care (Participant Identification Centres; PICs). We will establish the best method for determining quality of life using patient focus groups as well as the optimal technique for assessing the function of the heart using cardiac ultrasound (echocardiography). Patients will remain on study therapy for one year and a comparison made of the effects of treatment compared to baseline. The aim of the study is to identify whether these treatments can improve quality of life and heart function, and lay the groundwork for a larger clinical trial that will determine the best and most cost-effective rate-control strategy for patients with AF.

  • REC name

    East Midlands - Derby Research Ethics Committee

  • REC reference

    16/EM/0178

  • Date of REC Opinion

    18 Jul 2016

  • REC opinion

    Further Information Favourable Opinion