Predischarge Initiation of Ivabradine in the Management of Heart Failure (PRIME-HF)
Status:
Completed
Trial end date:
2018-10-15
Target enrollment:
Participant gender:
Summary
The PRIME-HF study is a multi-center, patient-level, randomized, open-label study of
approximately 450 patients with reduced (left ventricular ejection fraction) LVEF of ≤ 35%
and heart-rate ≥70 beats per minute (bpm) who are being discharged from the hospital
following stabilization from acute heart failure (HF)(primary or secondary) and will be
randomized to a treatment strategy of predischarge initiation of ivabradine or usual care.
All participants should have a follow-up visit within 7-14 days of hospital discharge. Heart
rate and systolic blood pressure will be assessed at this clinical visit. For participants
randomized to predischarge initiation of ivabradine and on ivabradine 5mg BID, the heart rate
may be used to adjust the dose the dose to 2.5mg BID or 7.5mg BID. For participants
randomized to usual care, ivabradine may be initiated at the provider's discretion. All
participants will have a second follow-up study visit 6 weeks (42 +/- 14 days)
post-discharge. Heart rate, systolic blood pressure and quality of life (KCCQ and PGA) will
be assessed. For participants already taking ivabradine in either treatment group, the heart
rate may again be used to adjust the dose of ivabradine. For participants not yet receiving
ivabradine, it may be initiated at the provider's discretion. All participants will receive a
90 (+/-7) day post-discharge phone call by site to assess for event status and tolerability
of ivabradine. All participants will have a final study visit at 180 (+/-14) days
post-discharge. Heart rate, systolic blood pressure and quality of life (Kansas City
Cardiomyopathy Questionnaire and Patient Global Assessment) will be assessed. The attending
physician may initiate ivabradine per usual care clinical practice.
The primary hypothesis of the PRIME-HF study is that, compared with usual care, a treatment
strategy of initiation of ivabradine prior to discharge for a hospitalization with acute HF
will be associated with a greater proportion of participants using ivabradine at 180 days.
Secondary objectives are to assess the impact of predischarge initiation of ivabradine
on:Heart Rate (Change in heart rate from baseline to 180 days and Median heart rate at 180
days) and Patient-Centered Outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ) and
Patient Global Assessment (PGA)). Tertiary objectives will be to explore the impact of
predischarge initiation of ivabradine on other assessments of evidence-based implementation
of ivabradine and beta-blockers at 180 days. Evaluations will incorporate data based on
whether or not indication status was retained and whether or not an ivabradine prescription
was provided. Tolerability of ivabradine and adverse events during study follow-up.