ISRCTN95259705已完成4 期
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)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
研究概览
简要总结
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28729311 2020 results in https://doi.org/10.1001/jama.2020.23138 (added 25/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult patients aged 60 years or older
- •2. 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
- •3. Symptoms of breathlessness (New York Heart Association Class II or more)
- •4. Able to provide written informed consent
排除标准
- •Current exclusion criteria as of 22/06/2018:
- •1. Established clinical indication for beta-blocker therapy, e.g. myocardial infarction in the last 6 months
- •2. 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
- •3. Baseline heart rate history of atrioventricular node ablation
- •4. History of second or third-degree heart block
- •5. Supraventricular arrhythmias associated with accessory conducting pathways (e.g. Wolff-Parkinson-White syndrome) or a history of ventricular tachycardia or fibrillation
- •6. Decompensated heart failure (evidenced by need for intravenous inotropes, vasodilators or diuretics) within 14 days prior to randomisation
- •7. A current diagnosis of obstructive hypertrophic cardiomyopathy, myocarditis or constrictive pericarditis
- •8. Received or on waiting list for heart transplantation
- •9. Receiving renal replacement therapy
- •10. Major surgery, including thoracic or cardiac surgery, within 3 months of randomisation
- •11. Severe, concomitant non-cardiovascular disease (including malignancy) that is expected to reduce life expectancy
- •Previous exclusion criteria:
- •1. Established clinical indication for beta-blocker therapy, e.g. myocardial infarction in the last 6 months
- •2. 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
- •3. Baseline heart rate history of atrioventricular node ablation
- •4. Decompensated heart failure (evidenced by need for intravenous inotropes, vasodilators or diuretics) within 14 days prior to randomisation
- •5. A current diagnosis of obstructive hypertrophic cardiomyopathy, myocarditis or constrictive pericarditis
- •6. Received or on waiting list for heart transplantation
- •7. Receiving renal replacement therapy
- •8. Major surgery, including thoracic or cardiac surgery, within 3 months of randomisation
- •9. Severe, concomitant non-cardiovascular disease (including malignancy) that is expected to reduce life expectancy
研究者
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