Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01505179
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2011-12-08
Brief Title:
The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2020-01
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:
RAZE
Brief Summary:
The purpose of this study is to determine whether treatment with Ranolazine will improve exercise capacity in patients with Heart Failure with preserved left ventricular ejection fraction or HFPEF
Detailed Description:
Denise Barnard MD and her associates are conducting a research study to find out more about ways to improve symptoms in patients with Heart Failure with Preserved Ejection Fraction HFPEF Heart failure with preserved ejection fraction is a condition where the heart squeezes well but is stiff This stiffness in the heart muscle makes the heart unable to fill leading to shortness of breath and decreased exercise tolerance Subjects with HFPEF are asked to participate in this study There will be approximately 40 participants enrolled in this study The purpose of this study is to investigate the effects of Ranolazine Ranexa in patients with HFPEF The study is sponsored by the manufacturers of the drug Gilead Pharmaceuticals
Ranolazine is a drug that affects the ion channels in the heart In patients with heart failure these ion channels do not work properly and contribute to make the heart stiff A stiff heart leads to the symptoms of shortness of breath which patients with HFPEF experience Due to its properties Ranolazine may improve this stiffness Ranolazine could improve subjects shortness of breath and ability to exercise
Currently ranolazine carries FDA approval for the treatment of chronic angina only We intend to study ranolazine in patients with HFPEF in the absence of documented ischemia to determine whether the drugs lusitropic properties can improve exercise capacity in HFPEF patients
Previous trials of ranolazine in patients with chronic angina found that there was a dose-dependent relationship between improvements in exercise capacity and ranolazine However there did appear to be a plateau in which 1500 mg of ranolazine twice daily improved exercise capacity only slightly more than 1000 mg of ranolazine given twice daily Additionally there was a substantially higher rate of adverse events mainly nausea dizziness and asthenia with the higher dose Given the desire to maximize benefit and minimize the risk of adverse events ranolazine 1000 mg by mouth twice daily was chosen as the target dose
To properly evaluate the effects of Ranolazine this research study is set up as a double blind placebo controlled study Subjects will be randomly assigned like rolling a dice to either Ranolazine or placebo inactive substance Subjects will have a 50 chance of getting the study drug and 50 chance of getting placebo
Ranolazine is a drug that affects the ion channels in the heart In patients with heart failure these ion channels do not work properly and contribute to make the heart stiff A stiff heart leads to the symptoms of shortness of breath which patients with HFPEF experience Due to its properties Ranolazine may improve this stiffness Ranolazine could improve subjects shortness of breath and ability to exercise
Currently ranolazine carries FDA approval for the treatment of chronic angina only We intend to study ranolazine in patients with HFPEF in the absence of documented ischemia to determine whether the drugs lusitropic properties can improve exercise capacity in HFPEF patients
Previous trials of ranolazine in patients with chronic angina found that there was a dose-dependent relationship between improvements in exercise capacity and ranolazine However there did appear to be a plateau in which 1500 mg of ranolazine twice daily improved exercise capacity only slightly more than 1000 mg of ranolazine given twice daily Additionally there was a substantially higher rate of adverse events mainly nausea dizziness and asthenia with the higher dose Given the desire to maximize benefit and minimize the risk of adverse events ranolazine 1000 mg by mouth twice daily was chosen as the target dose
To properly evaluate the effects of Ranolazine this research study is set up as a double blind placebo controlled study Subjects will be randomly assigned like rolling a dice to either Ranolazine or placebo inactive substance Subjects will have a 50 chance of getting the study drug and 50 chance of getting placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 110344 | OTHER | UCSD Human Research Protections Program | None |