Bethesda, Maryland 20889


Purpose:

Investigate whether ranolazine, a novel anti-anginal agent with antiarrhythmic properties, has a role in the management of symptomatic ventricular premature beats.


Study summary:

The main objective is to compare the effect of ranolazine versus placebo on premature ventricular beats (using 24-hour ambulatory electrocardiographic monitoring) for subjects with symptomatic palpitations. Subject population will consist of seventy-two adult subjects of both sexes who have greater than 1,000 premature ventricular beats during initial monitoring.


Criteria:

Inclusion Criteria: - Subjects male and female 18 years and older - Symptoms of palpitations - Greater than or equal to 1,000 Ventricular Premature Beats during 24-hour electrocardiographic monitoring - Completion of a consent form prior to pre-randomization Holter monitor Exclusion Criteria: - Moderate to severe symptomatic heart failure, New York Heart Association Class III/IV - Moderate to severe symptomatic angina, Canadian Cardiovascular Classification III/IV - Moderate to severe structural heart disease in the absence of an implantable cardiac defibrillator in a subject who would otherwise be eligible for a defibrillator (e.g. history of myocardial infarction and a left ventricular ejection fraction less than 30%) - Clinically significant hepatic disease (cirrhosis or chronic hepatitis) or abnormal liver associated enzymes greater than three times the upper limits of normal - A baseline corrected QT interval greater than or equal to 500msec or history of congenital channelopathy (long QT syndrome, Brugada syndrome) or torsades de pointes. - Treatment with agents known to prolong the QTc interval - Treatment with agents that are potent or moderately potent inhibitors of CYP3A, to include, but is not limited to the following: ketoconazole, HIV protease inhibitors (i.e. ritonavir), macrolide antibiotics (i.e. clarithromycin), diltiazem and verapamil - Females who are pregnant, planning to get pregnant, or breast feeding ( females under the age of 55 years who have not previously undergone surgical sterilization procedures will have serum qualitative pregnancy testing) - Thyroid stimulating hormone less than 0.27 IU/mL - Serum magnesium less than 1.5mg/dL - Serum potassium less than 3.5 mEq/dL or greater than 5.0 mEq/dL - Estimated GFR less than 30 mL/min


NCT ID:

NCT01996618


Primary Contact:

Principal Investigator
Michael S Cahill, MD
Walter Reed National Military Medical Center

Michael S Cahill, MD
Phone: 301-295-0394
Email: michael.s.cahill.mil@health.mil


Backup Contact:

Email: carin.j.smith.mil@health.mil
Carin J Smith, MD
Phone: 301-295-0394


Location Contact:

Bethesda, Maryland 20889
United States

Michael S Cahill, MD
Phone: 301-295-0394
Email: michael.s.cahill.mil@health.mil

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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