Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study
试验速览
- 阶段
- 2 期
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days)
研究概览
简要总结
This proposal details the implementation of an international (Singapore and New Zealand) multi-centre study to test a novel therapeutic strategy aimed at reducing the burden of atrial fibrillation - an important medical condition with major healthcare implications. Unique aspects of this study include i) a non-arrhythmic treatment target (mineralocorticoid receptor antagonism) -targeting the arrhythmogenic substrate of AF before it becomes permanently established, ii) the use of pacemaker monitoring capability to accurately document AF burden, thus increasing the power of the study and iii) multi-national collaborative, double blind design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years (without child-bearing potential for women);
- •With a permanent pacemaker capable of AF monitoring;
- •Device documented AF in the last 12 months; Defined as:
- •i. atrial high rate events (AHRE) > 220 bpm for >1% of the time; or ii. > 6 mins on at least one occasion
排除标准
- •Persistent (defined as sustained AF lasting continuously for 7 or more days)
- •History of heart failure with indication for MRAs
- •Any existing clinical indication for MRA or K+ sparing diuretic such as uncontrolled hypertension or oedema
- •Contraindication to MRA
- •Severe renal dysfunction (eGFR <30ml/min by CKD-Epi)
- •Sustained hyperkalaemia (defined as K+ >5mmol/L in the absence of reversible cause)
- •Receiving AF suppression pacing
- •Women of child bearing potential
- •Patients taking medications which may interact with the study drug or increase the level of potassium in the blood, include lithium, amiloride, cyclosporine, eplerenone, tacrolimus, and triamterene.
研究组 & 干预措施
Active
For patients randomized to active experimental arm: Spironolactone
Patient will receive study drug for 18 months. Study drug dosages are 1 tablet alternate day, 1 tablet per day, or 2 tablets per day, with 1 tablet being 25mg spironolactone. Study drugs are titrated every 3 months based on patients' potassium and eGFR blood tests results.
干预措施: Spironolactone 25mg (Drug)
Control
For patients randomized to control arm: Placebo
Patient will receive placebo for 18 months. Placebo dosages are 1 tablet alternate day, 1 tablet per day, or 2 tablets per day. Placebo are titrated every 3 months based on patients' potassium and eGFR blood tests results.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days)
时间窗: 18 months
Development of persistent AF (defined as the first episode of sustained AF lasting for more than 7 days)
次要结局
- Number of AF episodes(18 months)
- Number of admissions for AF(18 months)
- Change in LV volumes in millimetre(18 months)
- Change in systolic and diastolic function(18 months)
- Change in cardiac and systemic markers(18 months)
- Change in cardiac and systemic markers of inflammation(18 months)
- Change in cardiac and systemic markers of fibrosis(18 months)
- Number of symptomatic AF episodes(18 months)
- Change in LA volumes in millimetre(18 months)
- Percentage of total time in AF.(18 months)