Ignite Creation Date:
2024-05-05 @ 9:57 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00998218
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2009-10-16
Brief Title:
Effect of Ranolazine on Arrhythmias and Microvolt T- Wave Alternans MVTWA Patients With LV Dysfunction
Sponsor:
Aspirus Heart and Vascular Institute-Research and Education
Organization:
Aspirus Heart and Vascular Institute-Research and Education
Study Overview
Official Title:
The Effect of Ranolazine on Cardiac Arrhythmias and Microvolt T- Wave Alternans in Patients With Significant Left Ventricular Dysfunction
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose this investigation is to more thoroughly investigate the effects of ranolazine on arrhythmias and microvolt t-wave alternans in patients who have an automatic implantable cardioverter defibrillator AICD implanted either prophylactically to prevent sudden cardiac death as well as in patients who may have had a clinically significant arrhythmic event prompting the insertion of the automatic implantable cardioverter defibrillator It is anticipated this study will provide valuable new insight into the potential use of ranolazine to treat arrhythmias in higher risk patients
Detailed Description:
The device clinic of Aspirus Wausau Hospital follows approximately 2800 patients with pacemakers and automatic implantable cardioverter defibrillators AICD Approximately 300 of these patients have had an AICD inserted for primary or secondary arrhythmia prevention From these 300 patients approximately 20 patients who have an AICD implanted either prophylactically or for an established malignant arrhythmia will be recruited for this short study
This is a study to investigate the effect of ranolazine on arrhythmias detected by their device to see if it will reduce abnormal beats It will also study whether ranolazine will impact microvolt t-wave alternans MVTWA a measure of the tendency to have a serious arrhythmia Approximately 10 patients with ischemic cardiomyopathy and 10 patients with a non-ischemic cardiomyopathy will be chosen All will have an ejection fraction of 40 or less Prior to institution of ranolazine a MVTWA study will be performed Cambridge Heart Inc The AICD will be used to generate the increase in the heart rate needed to induce MVTWA Each patient will have MVTWA assessed at 80 beatsminute and then again at 110 beatsminute To eliminate interpretation bias the auto interpretation feature of the MVTWA device will be used to determine whether the study is positive MVTWA present or negative MVTWA absent or indeterminate In the coarse of this study each patient will undergo a total of 3 MVTWA studies in an identical manner using the AICD to provide the needed changes in heart rate
After informed consent is obtained the patient will begin a 10-day ranolazine run in Each randomized participant will be given a 10-day supply of ranolazine to make certain they tolerate the medication constipation is by far the most common limiting side effect Each participant will be started on 500 mg BID and after 3 days increased to 1000 mg BID Participants able to tolerate at least 500 mg BID will then be considered eligible to participate in the study and randomly assigned to either ranolazine at 1000 mg BID or 500 mg BID if the 1000 mg dose was not tolerated or a comparable placebo for the next 4 weeks
At least 3 days after the run in and prior to randomization each patient will be brought in for or the baseline MVTWA and the device clinic will purge the AICD of data and reset the data counter The patient will then immediately begin either placebo or ranolazine according to randomization After 4 weeks the MVTWA study will be repeated on either placebo or ranolazine and the arrhythmia data down loaded from the AICD recorded and the arrhythmia counters and device operation counter again reset Each patient will then cross over to the other therapy ranolazine or placebo for the next 4 weeks and the device interrogated and the MVTWA study repeated in an identical manner
This is a study to investigate the effect of ranolazine on arrhythmias detected by their device to see if it will reduce abnormal beats It will also study whether ranolazine will impact microvolt t-wave alternans MVTWA a measure of the tendency to have a serious arrhythmia Approximately 10 patients with ischemic cardiomyopathy and 10 patients with a non-ischemic cardiomyopathy will be chosen All will have an ejection fraction of 40 or less Prior to institution of ranolazine a MVTWA study will be performed Cambridge Heart Inc The AICD will be used to generate the increase in the heart rate needed to induce MVTWA Each patient will have MVTWA assessed at 80 beatsminute and then again at 110 beatsminute To eliminate interpretation bias the auto interpretation feature of the MVTWA device will be used to determine whether the study is positive MVTWA present or negative MVTWA absent or indeterminate In the coarse of this study each patient will undergo a total of 3 MVTWA studies in an identical manner using the AICD to provide the needed changes in heart rate
After informed consent is obtained the patient will begin a 10-day ranolazine run in Each randomized participant will be given a 10-day supply of ranolazine to make certain they tolerate the medication constipation is by far the most common limiting side effect Each participant will be started on 500 mg BID and after 3 days increased to 1000 mg BID Participants able to tolerate at least 500 mg BID will then be considered eligible to participate in the study and randomly assigned to either ranolazine at 1000 mg BID or 500 mg BID if the 1000 mg dose was not tolerated or a comparable placebo for the next 4 weeks
At least 3 days after the run in and prior to randomization each patient will be brought in for or the baseline MVTWA and the device clinic will purge the AICD of data and reset the data counter The patient will then immediately begin either placebo or ranolazine according to randomization After 4 weeks the MVTWA study will be repeated on either placebo or ranolazine and the arrhythmia data down loaded from the AICD recorded and the arrhythmia counters and device operation counter again reset Each patient will then cross over to the other therapy ranolazine or placebo for the next 4 weeks and the device interrogated and the MVTWA study repeated in an identical manner
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None