The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial is the first randomised clinical trial of digoxin vs beta-blockers in patients with atrial fibrillation and heart failure symptoms. It is a unique trial as it uses patient and public involvement (PPI) in trial design and management. In other words, the RATE-AF trial is carried out with or by the members of the public instead of being about or for them.
The application of PPI in trial development and management offers several benefits. First, it can augment patient recruitment and increase enrollment rates. PPI can also assist in the overall deployment of a clinical trial, ethical approval, protocol amendments if required, improved participant adherence and reduced cost. In addition, PPI can help embed the patient voice into clinical research, leading to overall benefits for all stakeholders.
The RATE-AF trial addresses a major gap in the management of atrial fibrillation. One hundred and sixty patients with permanent AF and dyspnoea were recruited to the trial.
Researchers found no difference in the primary outcome of the physical component of quality of life, long-term heart rate control, deterioration in left ventricular ejection fraction between digoxin and beta-blockers. Patients in the digoxin group had better improvement in modified European Heart Rhythm Association functional class compared to beta-blockers. Less adverse events were also reported with digoxin compared to beta-blockers. Overall, many of the patient-reported elements of general and treatment-related quality of life were observed to be better with digoxin.
Study findings are also important, but another important element of the RATE-AF trial is the involvement of patients, carers and the public. It is a unique approach that should be more broadly applied across other clinical trials and specialties.
Source: European Heart Journal
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