Recruiting

RanolazineStudy to Reduce Symptoms of Premature Beats With Ranolazine

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT01996618

Conditions

Premature Ventricular Beats

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ranolazine

Study Details

Brief summary:

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

Conditions

Premature Ventricular Beats

Study ID

NCT01996618

Start date

Jan, 2014

Status verified date

Nov, 2013

Completion date

Jul, 2016

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ranolazine

Subjects 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.

placebo comparator: Placebo

Subjects 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.

Interventions

Ranolazine

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) with the plan to then undergo a repeat 24 hour ambulatory electrocardiographic monitoring in 6 days.

Primary outcome measure

Reduction in Premature Ventricular Beats [ Time Frame: 24-hour Holter Monitor after 14 days of therapy ]

Central Contacts and Locations

Central contacts

Michael S Cahill, MD

301-295-0394 michael.s.cahill.mil@health.mil

Carin J Smith, MD

301-295-0394 carin.j.smith.mil@health.mil

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889

Contacts

Michael S Cahill, MD

301-295-0394 michael.s.cahill.mil@health.mil

Principal Investigator:

Michael S Cahill, MD

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

May 1, 2015

Last verified

Nov, 2013

Keywords

Premature Ventricular Beats
Premature Heart Beats
Ranolazine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2015-05-01.