Study to Reduce Symptoms of Premature Beats With Ranolazine

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Premature Ventricular Beats

In brief

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

Key facts

Study ID

NCT01996618

Run by

Walter Reed National Military Medical Center

People needed

72

Starts

2014-01-01

Expected to finish

2016-07-01

Last updated by the study team

2015-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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