Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Implementation of a palliative care consultation trigger tool for hospitalised patients with acute decompensated heart failure

Heart failure is a leading cause of hospitalisations. Integration of palliative care services with medical therapy in the management of hospitalised patients with heart failure is imperative. Unfortunately, there are no standardised criteria for palliative care referrals among hospitalised patients with acute decompensated heart failure. The objective of our quality improvement project was to develop and implement a palliative care consult trigger tool for hospitalised patients with acute decompensated heart failure. We found that among eligible patients, palliative care referrals were underused, likely contributing to misalignment of goals of care and suboptimal advance care planning. We developed a trigger tool and designed and implemented structured multicomponent educational interventions to improve the appropriateness and timeliness of inpatient palliative care consultations in this high-risk population. The educational interventions led to a significant increase in the rate of appropriate inpatient palliative care consultations among hospitalised patients with acute decompensated heart failure (46.3% vs 27.7%; p=0.02). In addition, palliative care referrals resulted in better alignment of goals of care at the time of hospital discharge, as measured by a significant increase in the completion rate of a healthcare proxy form (11.4% vs 47.2%; p<0.001) and a Medical Order for Life-Sustaining Treatment form (2.0% vs 24.1%; p<0.001), as well as the establishment of a Do-Not-Resuscitate order (2.7% vs 29.6%; p<0.001). Furthermore, the intervention resulted in a significant decrease in the hospital readmission rate up to 90 days post-discharge (43.6% vs 8.3%; p<0.001). This quality improvement project calls for the development and adoption of standardised criteria for palliative care referrals to benefit hospitalised patients with heart failure and reduce symptom burden, align goals of care and improve quality of life

Response by Sex in Patient-Centered Outcomes With Baroreflex Activation Therapy in Systolic Heart Failure

The aim of this study was to assess sex differences in the efficacy and safety of baroreflex activation therapy (BAT) in the BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial. Patients were randomized 1:1 to receive guideline-directed medical therapy (GDMT) alone (control group) or BAT plus GDMT. Pre-specified subgroup analyses including change from baseline to 6 months in 6-min walk distance (6MWD), quality of life (QoL) assessed using the Minnesota Living With Heart Failure Questionnaire (MLWHQ), New York Heart Association (NYHA) functional class, and N-terminal pro–B-type natriuretic peptide (NT-proBNP) were conducted in men versus women. Fifty-three women and 211 men were evaluated. Women had similar baseline NT-proBNP levels, 6MWDs, and percentage of subjects with NYHA functional class III symptoms but poorer MLWHQ scores (mean 62 ± 22 vs. 50 ± 24; p = 0.01) compared with men. Women experienced significant improvement from baseline to 6 months with BAT plus GDMT relative to GDMT alone in MLWHQ score (−34 ± 27 vs. −9 ± 23, respectively; p < 0.01), 6MWD (44 ± 45 m vs. −32 ± 118 m; p < 0.01), and improvement in NYHA functional class (70% vs. 27%; p < 0.01), similar to the responses seen in men, with no significant difference in safety. Women receiving BAT plus GDMT had a significant decrease in NT-proBNP (−43% vs. 7% with GDMT alone; difference −48%; p < 0.01), while in men this decrease was −15% versus 2%, respectively (difference −17%; p = 0.08), with an interaction p value of 0.05. Women in BeAT-HF had poorer baseline QoL than men but demonstrated similar improvements with BAT in 6MWD, QoL, and NYHA functional class. Women had a significant improvement in NT-proBNP, whereas men did not. (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196) [Display omitted