Effect of High-dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Arrhythmias
研究概览
简要总结
Heart failure patients represent a group of individuals at higher risk for cardiac arrhythmias. There is a perception that caffeine consumption may represent an increase in this risk. Although the medical staff and health professionals suggest a reduction in the intake of this substance to patients considered at risk, there is no scientific proof for this recommendation.
Some animal studies suggest a possible association between arrhythmias and caffeine use with higher doses, but this finding did not appear in human studies. In particular, little is known about the association between caffeine consumption and arrhythmias in patients with heart failure, especially at higher doses of consumption.
More specific and safe guidelines on caffeine consumption are needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure in NYHA functional class I-III
- •LV Ejection fraction <45%
- •Age > 18 y.o.
- •Cardio-defibrillator implanted with normal functioning with at least 30 days.
排除标准
- •Impossibility of take caffeine
- •Inability to perform an exercise test
- •Initial use of amiodarone in the last 2 months
- •Unstable ventricular arrhythmias, shock or ATP in the last 60 days
- •Hospitalization in the last two months due to decompensated heart failure
研究组 & 干预措施
Placebo
Lactose 500mg
Caffeine
Caffeine 500mg
干预措施: caffeine (Dietary Supplement)
结局指标
主要结局
Arrhythmias
时间窗: 6 hours
次要结局
未报告次要终点
研究者
Luis Eduardo Paim Rohde
Professor
Hospital de Clinicas de Porto Alegre