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Premature Ventricular Beats | Study to Reduce Symptoms of Premature Beats With Ranolazine

Premature Ventricular Beats research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Premature Ventricular Beats

Study Interventions

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:RanolazineAfter the initial 6 days of treatment with ranolazine, 500 mg twice daily or matched placebo, subjects will undergo repeat 24 hour electrocardiographic monitoring. If tolerated, the subjects will then have their study medication increased (Ranolazine 1,000 mg twice daily) with the plan to then undergo a repeat 24 hour ambulatory electrocardiographic monitoring in 6 days.

Study Arms

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.

RanolazineSubjects will be consented by the study investigator and then randomly assigned in an allocation-concealed fashion to double blinded treatment with either titrated doses of ranolazine or matched placebo. After the initial 6 days of treatment with ranolazine, 500 mg twice daily or matched placebo, subjects will undergo repeat 24 hour electrocardiographic monitoring. If tolerated, the subjects will then have their study medication increased (Ranolazine 1,000 mg twice daily or matching placebo) with the plan to then undergo a repeat 24 hour ambulatory electrocardiographic monitoring in 6 days. When the subject returns the monitor, subjects will enter the washout period (cessation of the study medication) for 6 days and have electrocardiographic monitoring prior to return to the subject's referring provider for care.

PlaceboSubjects will be consented by the study investigator and then randomly assigned in an allocation-concealed fashion to double-blinded treatment with either titrated doses of ranolazine or matched placebo. After the initial 6 days of treatment with ranolazine, 500 mg twice daily or matched placebo, subjects will undergo repeat 24 hour electrocardiographic monitoring. If tolerated, the subjects will then have their study medication increased (Ranolazine 1,000 mg twice daily or matching placebo) with the plan to then undergo a repeat 24-hour ambulatory electrocardiographic monitoring in 6 days. When the subject returns the monitor, subjects will enter the washout period (cessation of the study medication) for 6 days and have electrocardiographic monitoring prior to return to the subject's referring provider for care.

Study Status

Unknown status

Start Date: January 2014

Completed Date: July 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Reduction in Premature Ventricular Beats

Secondary Outcome: Changes in transthoracic echocardiographic parameters

Study sponsors, principal investigator, and references

Principal Investigator: Michael S Cahill, MD

Lead Sponsor: Walter Reed National Military Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01996618

Nanda S, Levin V, Martinez MW, Freudenberger R. Ranolazine--treatment of ventricular tachycardia and symptomatic ventricular premature beats in ischemic cardiomyopathy. Pacing Clin Electrophysiol. 2010 Dec;33(12):e119-20. doi: 10.1111/j.1540-8159.2010.02733.x.

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