Ranolazine for Improving Symptoms of Palpitations

Ischemic Heart Disease Clinical Trial

— RYPPLE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01495520
• Other study ID #: 671/2011/D
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 15, 2011
• Last updated: March 6, 2013
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2013
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD
• Phone: +39064997
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours

• Severe renal failure

• Severe hepatic failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Ranolazine
os, pill, 750 mg, b.i.d., 30 days
• Placebo
os, pill, b.i.d., 30 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of symptoms of palpitations	Occurrence of symptoms of palpitations	Up to 30 days	No
Secondary	Occurrence of arrhythmia in case of symptoms of palpitations	Definition of presence, number, type and duration of the arrhythmia in case of the patient-reported symptoms of palpitations	Up to 30 days	No