Loading
Ivabradine / Heart Failure · Phase 4 Trial
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a terminated Phase 4 RCT investigating ivabradine initiated at observation unit discharge in acute heart failure patients, primarily African American. The trial enrolled only 19 participants before termination and has reported no outcome results in this registry record.
Phase 4, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Heart Failure; age from 19 Years; to 89 Years. Intervention: Ivabradine (Corlanor). Compared with: Placebo — Placebo Comparator. n = 19. 2 sites: United States.
This is a terminated Phase 4 RCT investigating ivabradine initiated at observation unit discharge in acute heart failure patients, primarily African American. The trial enrolled only 19 participants before termination and has reported no outcome results in this registry record.
Primary outcome measure (change in heart rate) is a surrogate; no hard clinical outcomes (hospitalizations, mortality) reported. Registry record contains no efficacy, safety, or statistical data; cannot evaluate any treatment effect.
No clinical impact can be assessed because this trial was terminated and reported no outcomes. The registry record indicates the study question (ivabradine safety and efficacy in post-observation-unit discharge heart failure) remains unanswered.
This is a terminated trial registry record with only 19 participants enrolled and no results posted; it represents early-phase exploratory work in an understudied population without outcome data.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed because this trial was terminated and reported no outcomes. The registry record indicates the study question (ivabradine safety and efficacy in post-observation-unit discharge heart failure) remains unanswered.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT03168529). This is a study registration, not published results. Lead sponsor: Phillip Levy. Recruitment status: TERMINATED. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 19 participants (ACTUAL). Conditions: Heart Failure. Interventions: DRUG: Ivabradine; DRUG: Placebo. Primary outcome measures: Change in Heart Rate , Heart rate to be recorded at baseline, day 14 (+/-1), and day 28 (+/-2).. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.