Ivabradine in Stage D Heart Failure Patients on Chronic Inotropes
Status:
Withdrawn
Trial end date:
2021-08-31
Target enrollment:
Participant gender:
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.
Ivabradine's 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
ivabradine's 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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore