Clinical trial NCT01495520: Ranolazine for Improving Symptoms of Palpitations
Official title: Ranolazine for the Treatment of sYmPtoms of PaLpitations in patiEnts With Ischemic Heart Disease - The RYPPLE Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Heart Disease
Keywords: Arrhythmias
palpitations
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of symptoms of palpitations
timeFrame: Up to 30 days
Secondary outcomes:
measure: Occurrence of arrhythmia in case of symptoms of palpitations
timeFrame: Up to 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University Sapienza
name: Francesco Pelliccia, MD
role: PRINCIPAL_INVESTIGATOR
References: