Phase 4
N=161
Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)
Permanent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02391337 ↗Enrolled (actual)
161
Serious AEs
21.1%
Results posted
Jun 2021
Primary outcome: Primary: Patient Reported Quality of Life (SF-36) — 29.7; 31.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bisoprolol (Drug); Digoxin (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Birmingham
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Quality of Life (SF-36) |
29.7; 31.9 | — |
| SECONDARY Left Ventricular Ejection Fraction |
59.8; 59.7 | — |
| SECONDARY Diastolic Function- Measured by the E/e'. |
10.8; 10.8 | — |
| SECONDARY B-type Natriuretic Peptide (BNP) at 6 Months. |
1209; 1057.5 | — |
| SECONDARY Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months. |
329; 366 | — |
| SECONDARY Patient Reported Outcomes- (AFEQT) at 12 Months. |
68.1; 75.6 | — |
| SECONDARY Patient Reported Outcomes (SF36) Version 2 at 12 Months. |
29.4; 32.5; 51.3; 53.6; 27.5; 31.5 | — |
| SECONDARY Patient Reported Outcomes (EQ-5D-5L) |
0.62; 0.66 | — |
| SECONDARY Ambulatory Heart-rate. |
73.7; 78.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adult patients aged 60 years or older, able to provide informed written consent
- Permanent AF, characterised (at time of randomisation) as a physician decision for rate-control with no plans for cardioversion, anti-arrhythmic medication, or ablation therapy
- Symptoms of breathlessness (New York Heart Association Class II or more)
- Able to provide written, informed consent
Exclusion Criteria
- Established indication for beta-blocker therapy, e.g. survived myocardial infarction in the last 6 months
- Known contraindications for therapy with beta-blockers or digoxin, e.g. a history of severe bronchospasm that would preclude use of beta-blockers, or known intolerance to these medications
- Baseline heart rate <60 bpm
- Known intolerance of beta-blockers or digoxin
- A history of severe bronchospasm (e.g. due to asthma) that would preclude use of beta-blockers
- Baseline heart rate <60 bpm
- History of second or third-degree heart block
- Supraventricular arrhythmias associated with accessory conducting pathways (e.g. Wolff-Parkinson-White syndrome) or a history of ventricular tachycardia or fibrillation
- Planned pacemaker implantation, pacemaker-dependent rhythm or history of atrioventricular node ablation
- Decompensated heart failure (evidenced by need for intravenous inotropes, vasodilators or diuretics) within 14 days prior to randomisation
- A current diagnosis of hypertrophic cardiomyopathy, myocarditis or constrictive pericarditis
- Received or on waiting list for heart transplantation
- Initiation of cardiac resynchronization therapy (with/without defibrillator) within 6 months prior to randomisation
- Intravenous infusions for heart failure (inotropes, vasodilators or diuretics) within 7 days prior to randomisation
- A current diagnosis of hypertrophic cardiomyopathy, myocarditis or constrictive pericarditis
- Received or on waiting list for heart transplantation
- Receiving renal replacement therapy
- Major surgery, including thoracic or cardiac surgery, within 3 months of randomisation
- Severe, concomitant non-cardiovascular disease (including malignancy) that is expected to reduce life expectancy
Data sourced from ClinicalTrials.gov (NCT02391337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.