Study to Reduce Symptoms of Premature Beats With Ranolazine

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed National Military Medical Center
• Treatments: Ranolazine

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