Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03631654
Status:
WITHDRAWN
Last Update Posted:
2022-01-05
First Post:
2018-08-03
Brief Title:
Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes A Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to obtain funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ivabradine a selective inhibitor of the If current in the sinoatrial node provides heart rate reduction and leads to a reduction in heart failure hospitalizations For this reason the American College of Cardiology ACC and the American Heart Association AHA guidelines provide a class IIa recommendation for ivabradine in stable heart failure patients with LVEF 35 and New York Heart Association NYHA class II-III symptoms who are on a beta blocker at maximum tolerated dose with a resting heart rate of 70 beats per minute or greater While ivabradine leads to improvement in outcomes in stable NYHA class II-III chronic heart failure patients its role in class IV stage D heart failure and cardiogenic shock is less clear
Ivabradines effect on acute cardiogenic shock has been evaluated by two recent studies In the MODIFY trial a randomized control study evaluating ivabradine in patients with multiorgan dysfunction the addition of ivabradine did not result in significant heart rate reductions or other positive clinical outcomes However a small prospective trial demonstrated a significant decrease in heart rate and NT-proBNP with the addition of ivabradine in patients with acute cardiogenic shock on dobutamine While few data investigate ivabradines role in acute cardiogenic shock it has yet to be studied in heart failure patients on long-term inotropic therapy Inotropes such as dobutamine and milrinone result in tachycardia and may lead to ventricular arrhythmias Moreover patients on chronic inotropes are typically off beta blockers and have few pharmacological options available to help reduce heart rates Ivabradine may have a role in decreasing heart rate and improving outcomes in patients on chronic inotropes
Given the benefits of ivabradine in stable chronic heart failure patients we plan to perform a study investigating the role of ivabradine in NYHA Stage D patients on home inotropes
Our primary objective is to analyze changes in two cardiac biomarkers NT-proBNP and high-sensitivity troponin Our secondary outcomes include changes in noninvasive echocardiographic hemodynamics changes in arrhythmia burden and heart failure symptom modification based on 6-minute walk test results
Ivabradines effect on acute cardiogenic shock has been evaluated by two recent studies In the MODIFY trial a randomized control study evaluating ivabradine in patients with multiorgan dysfunction the addition of ivabradine did not result in significant heart rate reductions or other positive clinical outcomes However a small prospective trial demonstrated a significant decrease in heart rate and NT-proBNP with the addition of ivabradine in patients with acute cardiogenic shock on dobutamine While few data investigate ivabradines role in acute cardiogenic shock it has yet to be studied in heart failure patients on long-term inotropic therapy Inotropes such as dobutamine and milrinone result in tachycardia and may lead to ventricular arrhythmias Moreover patients on chronic inotropes are typically off beta blockers and have few pharmacological options available to help reduce heart rates Ivabradine may have a role in decreasing heart rate and improving outcomes in patients on chronic inotropes
Given the benefits of ivabradine in stable chronic heart failure patients we plan to perform a study investigating the role of ivabradine in NYHA Stage D patients on home inotropes
Our primary objective is to analyze changes in two cardiac biomarkers NT-proBNP and high-sensitivity troponin Our secondary outcomes include changes in noninvasive echocardiographic hemodynamics changes in arrhythmia burden and heart failure symptom modification based on 6-minute walk test results
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None