Ranolazine for Improving Symptoms of Palpitations (RYPPLE)

This study is not yet open for participant recruitment.
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01495520
First received: December 15, 2011
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Drug: Ranolazine
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Occurrence of symptoms of palpitations [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    Occurrence of symptoms of palpitations


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
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)
Arms Assigned Interventions
Active Comparator: Ranolazine
Patients will receive ranolazine 750 mg bid for 30 days
Drug: Ranolazine
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
Drug: Placebo
os, pill, b.i.d., 30 days
Other Name: Placebo

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495520

Contacts
Contact: Francesco Pelliccia, MD +39064997 f.pelliccia@mclink.it

Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Francesco Pelliccia, MD University Sapienza
  More Information

No publications provided

Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01495520     History of Changes
Other Study ID Numbers: 671/2011/D
Study First Received: December 15, 2011
Last Updated: March 6, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by University of Roma La Sapienza:
Arrhythmias
palpitations

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014