Ranolazine for the Treatment of sYmPtoms of PaLpitations in patiEnts With Ischemic Heart Disease - The RYPPLE Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Occurrence of symptoms of palpitations
研究概览
简要总结
Patients with ischemic heart disease often report multiple symptoms, including angina and palpitations. Ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels. It remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time. Aim of this study is to test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status of patients with ischemic heart disease by reducing the occurrence of palpitations.
详细描述
Background:
Patients with ischemic heart disease often report multiple symptoms, including angina and palpitations.
Ranolazine is a novel antianginal and antiischemic drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury. Furthermore, ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels.
It has previously been shown that treatment with ranolazine can reduce the frequency of supraventricular and ventricular tachycardia in the short term. In a subgroup analysis of the MERLIN-TIMI 36 trial, the continuous ECGs of 6,351 patients were analyzed. The results showed that, in comparison with placebo, treatment with ranolazine resulted in fewer episodes of ventricular tachycardia that lasted 8 beats or longer (5.3% versus 8.3%; P <0.001), and in fewer episodes of supraventricular tachycardia (44.7% versus 55%; P <0.001) and new-onset atrial fibrillation (1.7% versus 2.4%; P=0.08).
It remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of palpitations
- •Angiographically-proven coronary artery disease
- •Stable conditions
- •No recent acute coronary syndromes
- •Able to understand and willing to sign the informed consent form
- •Symptomatic patients (palpitation) with stable angina pectoris already on therapy with beta-blockers and/or calcium antagonists.
排除标准
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours
- •Severe renal failure
- •Severe hepatic failure
研究组 & 干预措施
Ranolazine
Patients will receive ranolazine 750 mg bid for 30 days
干预措施: Ranolazine (Drug)
Placebo
Patients will receive placebo for 30 days
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of symptoms of palpitations
时间窗: Up to 30 days
Occurrence of symptoms of palpitations
次要结局
- Occurrence of arrhythmia in case of symptoms of palpitations(Up to 30 days)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza