Ignite Creation Date:
2024-05-05 @ 10:42 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01163734
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2010-07-12
Brief Title:
Ranolazine in Diastolic Heart Failure
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study of Ranolazine in Patients With Heart Failure With Preserved Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2011-03
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:
RALI-DHF
Brief Summary:
Patients with CAD and clinical symptoms of heart failure or patients with suspected heart failure with preserved ejection fraction HFpEF will be enrolled Study drug will be given as continuous IV infusion followed by oral treatment for 13 days LV pressures and hemodynamic data will be measured prior to and after administration of study drug In addition Doppler ECHO cardiopulmonary exercise testing CPET and NT-pro-BNP determination will be performed Adverse events and safety labs will be collected and monitored
Detailed Description:
This is a randomized double-blind placebo-controlled proof-of-concept study of ranolazine in patients with heart failure with preserved ejection fraction HFpEF Patients will be randomized to receive ranolazine or placebo in a 151 ratio 12 ranolazine 8 placebo
Treatment will consist of intravenous infusion of study drug followed by oral treatment for a total of 14 days treatment period Study contact will be made approximately 14 days after the treatment period to assess safety
Cardiac catheterization will be performed for LV pressures and hemodynamic measurements before and after drug administration Doppler ECHO CPET and NT-pro-BNP determination will be performed at screening and at end of study Adverse events and safety labs will be monitored and collected
Treatment will consist of intravenous infusion of study drug followed by oral treatment for a total of 14 days treatment period Study contact will be made approximately 14 days after the treatment period to assess safety
Cardiac catheterization will be performed for LV pressures and hemodynamic measurements before and after drug administration Doppler ECHO CPET and NT-pro-BNP determination will be performed at screening and at end of study Adverse events and safety labs will be monitored and collected
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