Study to Reduce Symptoms of Premature Beats With Ranolazine



Status:Recruiting
Conditions:Cardiology, Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:January 2014
End Date:July 2016
Contact:Michael S Cahill, MD
Email:michael.s.cahill.mil@health.mil
Phone:301-295-0394

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Reduction of Symptomatic Ventricular Premature Beats With Ranolazine

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

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.

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
We found this trial at
1
site
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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mi
from
Bethesda, MD
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