Ranolazine Mediated PVC Reduction in Ischemic Heart Disease
United States6 participantsStarted 2014-12
Plain-language summary
The purpose of this study is to determine whether ranolazine has beneficial effects on cardiac ischemia through reduction of premature ventricular contraction burden.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males and females aged 18 years and older
* Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* History of ischemic heart disease (prior bypass or coronary stenting, documentation on cardiac catheterization, nuclear SPECT imaging, cardiac MR, stress echocardiography, or exercise stress testing). Subjects are not required to have chronic angina to be enrolled in the study
* Elevated PVC burden (1%) on prior Holter/event monitor in previous 12 months or evidence for PVC(s) on baseline ECG within prior 12 months.
* Sexually active females of childbearing potential must agree to utilize effective methods of contraception during heterosexual intercourse throughout the treatment period and for 14 days following discontinuation of the study medication
Exclusion Criteria:
* Hospitalization for hyperthyroidism, pericarditis, myocarditis, or pulmonary embolism within 4 weeks prior to screening
* Implantation of ICD or permanent pacemaker within 1 month of screening
* New York Heart Association (NYHA) Class III and IV heart failure or NYHA Class II heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic within 4 weeks prior to Screening.
* Myocardial infarction, unstable angina, or coronary artery bypass graft (CABG) surgery within three months prior to Screening or percutaneous coronary intervention (PCI) within 4 …
What they're measuring
1
The Effect of Ranolazine on the PVC Burden Over 30 Days
Timeframe: Baseline (7 day) Holter compared to day 30 (7 day) Holter