NCT01495520

Ranolazine for Improving Symptoms of Palpitations

Ranolazine for the Treatment of sYmPtoms of PaLpitations in patiEnts With Ischemic Heart Disease - The RYPPLE Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Purpose: The primary objective 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.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	Ranolazine	os, pill, 750 mg, b.i.d., 30 days
DRUG	Placebo	os, pill, b.i.d., 30 days

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-12-01
• Completion: 2016-12-01
• First posted: 2011-12-20
• Last updated: 2013-03-07