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Aims: It remains unclear if early administration of i.v. nesiritide in patients hospitalized with acute heart failure (AHF) is associated with improved clinical outcomes.Methods and Results: We analysed data from 7007 patients enrolled in ASCEND-HF to examine the associations between time to treatment with study medication (nesiritide or placebo) and clinical endpoints: (i) moderate to marked dyspnoea relief on a 7-point Likert scale at 6 h; (ii) 30-day all-cause mortality or re-hospitalization; and (iii) 30-day all-cause mortality. The median time to study drug administration was 16.7 h (25th, 75th percentiles = 6.5, 23.1), with significant regional variation (e.g. median of 13.0 h in Asia-Pacific vs. 18.4 h in North America). After risk adjustment, each hour delay in study medication after the first 10 h from initial hospital presentation was associated with modestly reduced odds of dyspnoea relief [(adjusted odds ratio (OR) 0.98, 95% confidence interval (CI) 0.98-0.99; P < 0.0001]. Every hour delay in study medication was associated with modestly higher all-cause mortality or re-hospitalization (unadjusted OR 1.01, 95% CI 1.01-1.02; P < 0.001) due to pre-randomization therapies and known predictors of 30-day outcomes (adjusted P = 0.12). There was no significant association between time to study drug and all-cause mortality (P > 0.08).Conclusion: In a large international AHF trial, time to treatment with study medication varied markedly across regions. Earlier administration of study medication was associated with modestly better dyspnoea relief, but not 30-day clinical outcomes. The association between timing of treatment with study medication and study endpoints may have implications for the interpretation of AHF studies and future trial design. [ABSTRACT FROM AUTHOR]

Background: Patients hospitalized for acute decompensated heart failure (ADHF) are at high risk for early mortality and rehospitalization. Risk stratification of ADHF using clinically available data on admission is increasingly important to integrate with clinical pathways. Our goal was to create a simple method of screening patients upon admission to identify those with increased risk of future adverse events., Methods: Using ASCEND-HF, a pragmatic clinical trial conducted in 398 sites globally, we developed and validated logistic regression risk models for (a) 30-day mortality/HF rehospitalization, (b) 30-day mortality/all-cause rehospitalization, (c) 30-day all-cause mortality, and (d) 180-day all-cause mortality. Fifty-one candidate variables were evaluated based on prior publications and clinical review. Final models were selected based on stepwise selection with entry and a staying criterion of P < .01. The 30-day mortality model was externally validated, and coefficients were converted to an additive risk score., Results: Among 7,141 patients, the median age was 67 years, 34% were female, and 80% had a left ventricular ejection fraction <40%. The models had between 5 and 12 risk factors with c-indices ranging from 0.68 to 0.75. A simplified score, including age, systolic blood pressure, sodium, blood urea nitrogen, and dyspnea at rest, discriminated 30-day mortality risk from 0.5% (score 0) to 53% (score 10)., Conclusions: Commonly available clinical variables provide simple risk stratification for clinical outcomes among patients with ADHF, and these models may be considered for integration into routine clinical care., (Copyright © 2015. Published by Elsevier Inc.)

Background: Translation of evidence-based heart failure (HF) therapies to clinical practice is incomplete and may vary internationally. We examined common measures of quality of care in patients enrolled in the international Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure trial., Methods and Results: Patients were admitted to 398 hospitals for acute HF in 5 regions (North America, n=3149; Latin America, n=658; Asia Pacific, n=1744; Central Europe, n=966; and Western Europe, n=490). Predefined quality indicators assessed at hospital discharge included the following: medications (angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers, aldosterone antagonists, hydralazine/nitrates, statin therapy, and warfarin), use (or planned use) of implantable intracardiac devices, and blood pressure control (<140/90 mm Hg). We determined regional variations in quality indicators as well as the temporal variation of these indicators during the course of the trial. There was significant variation in conformity among different quality indicators, ranging from 0% to 89%. Of all potential performance opportunities, 19 076 of 32 268 (59%) were met, with Central Europe highest at 64%, followed by North America (63%), Western Europe (61%), Latin America (56%), and Asia Pacific (51%; P<0.0001). North America, Central Europe, and Asia Pacific regions demonstrated a modest increase in quality indicator conformity over time, although there was no significant change in other regions., Conclusions: Quality of care for patients hospitalized with acute HF varies and remains suboptimal even within a randomized clinical trial, which included quality improvement interventions. Specific measures designed to improve performance measures should be implemented even within multicenter clinical trials.