Trial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation Unit
Status:
Unknown status
Trial end date:
2020-06-30
Target enrollment:
Participant gender:
Summary
Ivabradine (IVA) has been shown to decrease the risk of hospitalizations for worsening Heart
Failure and was associated with a trend towards improved mortality in the SHIFT1 trial.
SHIFT1 excluded patients within 4 weeks of hospital discharge, so the efficacy and safety of
IVA in this setting is less clear.
In today's health care environment more and more patients that present to the Emergency
Department (ED) for mild Acute Heart Failure (AHF) are being placed into observation unit and
subsequently discharged, or discharged outright from the ED. This is not only a growing
segment of patients, but also represents an important window of opportunity to intervene with
a potentially effective therapy.
Moreover, at this point in a patient's experience (being discharged after getting treated for
exacerbation of Heart Failure), it's not clear that beta blockers (BB) should yet be
increased/started due to the recent state of exacerbation.
Standard treatment of worsened heart failure presenting to the ED or urgent care includes
diuretics (e. g. furosemide) and vasodilators (e.g. ACE-I, ARB, Hydralazine/Isosorbide or
ARNi), but according to usual standard of care, titration of beta blockade is often reserved
for outpatient follow up after a period of demonstrated stability (in the ambulatory
setting).
This is in contradistinction to hospitalized patients, where patients have been observed by
the treating team for days, presumably show stability and improvement, and starting low dose
BB at the time of hospital discharge has been shown to be safe. As such these ED/Observation
discharge patients are often not optimal candidates for intensification of BB at the time of
release, and could be considered to be at maximally tolerated BB dose (for at least for 2-4
weeks). This may represent a vulnerable period for these patients; its unknown in the setting
of Observation discharge but evidence from hospitalized patients indicates that the highest
daily risk of rehospitalization is in the days just after discharge. IVA may be effective
post observation unit management (where lower risk Heart Failure (HF) patients are typically
placed), to reduce heart rate (without decreasing contractility, such as a BB would) to help
reduce the risk of hospitalization or emergency care, but safety and efficacy (in terms of
heart rate lowering) in this setting has not been previously explored.
Additionally, the SHIFT1 trial lacked African Americans and this unique patient population
has not been previously studied with IVA. The investigating sites serve a predominantly
African American patient population. Therefore the proposed study represents an important
opportunity to gather data on IVA effect in this understudied group of patients.