Outpatients with HFrecEF have a different clinical course than patients with HFpEF and HFrEF, with lower mortality, less frequent hospitalizations, and fewer composite end points. These patients may need to be investigated separately in outcomes studies and clinical trials.

Importance Persistent congestion is associated with worse outcomes in acute heart failure (AHF). Mineralocorticoid receptor antagonists at high doses may relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF. Objective To assess the impact of high dose spironolactone in addition to usual care on N-terminal pro-B-type natriuretic peptide (NTproBNP) levels compared to usual care alone. Design Double blind, placebo (or low dose)-controlled, multicenter, randomized clinical trial Setting Twenty-two acute care hospitals in the Unites States Participants Patients with AHF and NTproBNP level of ≥1000 pg/mL or B-type natriuretic peptide ≥250 pg/mL regardless of ejection fraction, previously receiving no or low-dose (12.5 or 25 mg daily) spironolactone Intervention High dose spironolactone (100 mg) vs. placebo or 25 mg spironolactone (usual care) daily for 96 hours Main Outcomes Measures The primary endpoint was change in NTproBNP levels from baseline to 96 hours. Secondary endpoints included clinical congestion score, dyspnea assessment, net urine output, and net weight change. Safety endpoints included hyperkalemia and changes in renal function. Results A total of 360 patients were randomized (median age 65 years, 36% women, 65% Caucasian, and median left ventricular ejection fraction of 34%. Baseline median NTproBNP levels were 4601 (2697, 9596) pg/ml in the high-dose spironolactone group and 3753 (1968, 7633) pg/ml in the usual care group. There was no significant difference in the log NTproBNP reduction between the two groups (−0.55 [−0.92, −0.18] with high-dose spironolactone and −0.49 [−0.98, −0.14] with usual care, P=0.57). None of the secondary endpoint or day-30 all-cause mortality or heart failure hospitalization rate differed between the two groups. The changes in serum potassium and estimated glomerular filtration rate at 24, 48, 72, and 96 hr. were similar between the two groups. Conclusion and Relevance Addition of high dose spironolactone to usual care in patients with AHF for 96 hours was well tolerated but did not improve either the primary or any of the secondary efficacy endpoints.

Background Simultaneous adherence with multiple self-care instructions among heart failure (HF) patients is not well described. Methods Patient-reported adherence to eight recommendations related to exercise, alcohol, medications, smoking, diet, weight, and symptoms was assessed among 308 HF patients using the Medical Outcomes Study Specific Adherence Scale questionnaire (0=‘never’, 5=‘always’; maximum score=40). A baseline cumulative score of ≥32/40 (average ≥80%) defined good adherence. Clinical events (death/transplantation/ventricular assist device), resource utilization, functional capacity (6-minute walk distance), and health status (Kansas City Cardiomyopathy Questionnaire [KCCQ]) were compared among patients with and without good adherence. Results Mean follow-up 2.0±1.0 years. Adherence ranged from 26.3% (exercise) to 89.9% (medications). A cumulative score indicating good adherence was reported by 35.7%, whereas good adherence with every behavior was reported by 9.1% of patients. Good adherence was associated with fewer hospitalizations (all-cause 87.8 vs. 107.6; P=0.018; HF 29.6 vs. 43.8; P=0.007), and hospitalized days (all-cause 422 vs. 465; P=0.015; HF 228 vs. 282; P<0.001) per 100 person-years; and better health status (KCCQ overall score 70.1±24.6 vs. 63.8±22.8; P=0.011). Adherence was not associated with clinical events or functional capacity. Conclusions Patient-reported adherence with HF self-care recommendations is alarmingly low and selective. Good adherence was associated with lower resource utilization and better health status.

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Background Recent trials with dexamethasone and hydrocortisone have demonstrated benefit in patients with coronavirus disease 2019 (COVID‐19). Data on methylprednisolone are limited. Methods Retrospective cohort of consecutive adults with severe COVID‐19 pneumonia on high‐flow oxygen (FiO2 ≥ 50%) admitted to an academic centre in New York, from 1 March to 15 April 2020. We used inverse probability of treatment weights to estimate the effect of methylprednisolone on clinical outcomes and intensive care resource utilization. Results Of 447 patients, 153 (34.2%) received methylprednisolone and 294 (65.8%) received no corticosteroids. At 28 days, 102 patients (22.8%) had died and 115 (25.7%) received mechanical ventilation. In weighted analyses, risk for death or mechanical ventilation was 37% lower with methylprednisolone (hazard ratio 0.63; 95% CI 0.47‐0.86; P = .003), driven by less frequent mechanical ventilation (subhazard ratio 0.56; 95% CI 0.40‐0.79; P = .001); mortality did not differ between groups. The methylprednisolone group had 2.8 more ventilator‐free days (95% CI 0.5‐5.1; P = .017) and 2.6 more intensive care‐free days (95% CI 0.2‐4.9; P = .033) during the first 28 days. Complication rates were not higher with methylprednisolone. Conclusions In nonintubated patients with severe COVID‐19 pneumonia, methylprednisolone was associated with reduced need for mechanical ventilation and less‐intensive care resource utilization without excess complications.

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