Ranolazine for Improving Symptoms of Palpitations (RYPPLE)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Ranolazine for the Treatment of sYmPtoms of PaLpitations in patiEnts With Ischemic Heart Disease - The RYPPLE Trial|
- Occurrence of symptoms of palpitations [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]Occurrence of symptoms of palpitations
- Occurrence of arrhythmia in case of symptoms of palpitations [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]Definition of presence, number, type and duration of the arrhythmia in case of the patient-reported symptoms of palpitations
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Ranolazine
Patients will receive ranolazine 750 mg bid for 30 days
os, pill, 750 mg, b.i.d., 30 days
Other Name: Ranexa TM, Gilead, US
Placebo Comparator: Placebo
Patients will receive placebo for 30 days
os, pill, b.i.d., 30 days
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495520
|Contact: Francesco Pelliccia, MDfirstname.lastname@example.org|
|Principal Investigator:||Francesco Pelliccia, MD||University Sapienza|