Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01705509
Status:
TERMINATED
Last Update Posted:
2020-02-18
First Post:
2012-10-10
Brief Title:
The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients ERIC
Sponsor:
Cardiovascular Institute of the South Clinical Research Corporation
Organization:
Cardiovascular Institute of the South Clinical Research Corporation
Study Overview
Official Title:
The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients ERIC
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to lack of resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERIC
Brief Summary:
This is a proof of concept trial using ranolazine a medication in patients with known Coronary Artery Disease and reduced left ventricular function EF 40 We propose that ranolazine therapy will result in demonstrative improvements in cardiac function that can be objectively assessed using the parameters measured with CPET We propose that demonstrative improvement in CPET parameters on ranolazine will translate into improved patient outcomes for this patient population
Detailed Description:
Selected patients will undergo a CPET evaluation The initial CPET will identify patients with underlying ischemia and serve as a baseline study Ischemia will be assessed using 1 peak VO2 measures the peak transport of O2 to the tissues when O2 extraction from the blood is maximal 2 the anaerobic threshold AT measures the sustainable work capacity in units of VO2 3 the O2-pulse measurements at the AT peak VO2 estimate stroke volume at those levels of exercise and 4 the relationship of O2 uptake to work rate ΔVO2ΔWR provides information on the ability of the cardiac output to increase Patients whoseCPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week -4 days to 1000mg BID A second CPET will be performed after 4 weeks - 4 days of maximum therapy CPET results before and after therapy will undergo a statistical comparison The initial off treatment CPET measurement will serve as the control to assess changes found during therapy No medication changes or revascularization procedures will occur during the study If patients require and undergo a medication change or a revascularization procedure they will be excluded from the study
Patients will be contacted at the completion of week one prior to up titration then at the end of week two to ensure tolerance and compliance with the 1000mg BID dose Patients will perform the second CPET study at week four - 1 week The trial medication will be assessed and counted to ensure that patients have taken there allotted pill count for the duration of the study Patients who are found to be noncompliant of less than 80 will be excluded from the study
Patients will be contacted at the completion of week one prior to up titration then at the end of week two to ensure tolerance and compliance with the 1000mg BID dose Patients will perform the second CPET study at week four - 1 week The trial medication will be assessed and counted to ensure that patients have taken there allotted pill count for the duration of the study Patients who are found to be noncompliant of less than 80 will be excluded from the study
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