Ranolazine for Improving Symptoms of Palpitations (RYPPLE)
Primary Purpose
Ischemic Heart Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Arrhythmias, 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ranolazine
Placebo
Arm Description
Patients will receive ranolazine 750 mg bid for 30 days
Patients will receive placebo for 30 days
Outcomes
Primary Outcome Measures
Occurrence of symptoms of palpitations
Occurrence of symptoms of palpitations
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01495520
First Posted
December 15, 2011
Last Updated
March 6, 2013
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01495520
Brief Title
Ranolazine for Improving Symptoms of Palpitations
Acronym
RYPPLE
Official Title
Ranolazine for the Treatment of sYmPtoms of PaLpitations in patiEnts With Ischemic Heart Disease - The RYPPLE Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
Arrhythmias, palpitations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
Patients will receive ranolazine 750 mg bid for 30 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo for 30 days
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa TM, Gilead, US
Intervention Description
os, pill, 750 mg, b.i.d., 30 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
os, pill, b.i.d., 30 days
Primary Outcome Measure Information:
Title
Occurrence of symptoms of palpitations
Description
Occurrence of symptoms of palpitations
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Occurrence of arrhythmia in case of symptoms of palpitations
Description
Definition of presence, number, type and duration of the arrhythmia in case of the patient-reported symptoms of palpitations
Time Frame
Up to 30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Pelliccia, MD
Phone
+39064997
Email
f.pelliccia@mclink.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Pelliccia, MD
Organizational Affiliation
University Sapienza
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ranolazine for Improving Symptoms of Palpitations
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