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Ranolazine for Improving Symptoms of Palpitations

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01495520
Acronym
RYPPLE
Enrollment
100
Registered
2011-12-20
Start date
2014-01-31
Completion date
2016-12-31
Last updated
2013-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

Arrhythmias, palpitations

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.

Interventions

DRUGRanolazine

os, pill, 750 mg, b.i.d., 30 days

DRUGPlacebo

os, pill, b.i.d., 30 days

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of symptoms of palpitationsUp to 30 daysOccurrence of symptoms of palpitations

Secondary

MeasureTime frameDescription
Occurrence of arrhythmia in case of symptoms of palpitationsUp to 30 daysDefinition of presence, number, type and duration of the arrhythmia in case of the patient-reported symptoms of palpitations

Contacts

Primary ContactFrancesco Pelliccia, MD
f.pelliccia@mclink.it+39064997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026