Ischemic Heart Disease | Ranolazine for Improving Symptoms of Palpitations
Ischemic Heart Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Ischemic Heart Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Ranolazineos, pill, 750 mg, b.i.d., 30 days
Drug:Placeboos, pill, b.i.d., 30 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RanolazinePatients will receive ranolazine 750 mg bid for 30 days
PlaceboPatients will receive placebo for 30 days
Start Date: January 2014
Completed Date: December 2016
Phase: Phase 4
Primary Outcome: Occurrence of symptoms of palpitations
Secondary Outcome: Occurrence of arrhythmia in case of symptoms of palpitations
Study sponsors, principal investigator, and references
Principal Investigator: Francesco Pelliccia, MD
Lead Sponsor: University of Roma La Sapienza