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We examined the effects of istaroxime in patients hospitalized for acute heart failure (AHF) related Society for Cardiovascular Angiography and Interventions (SCAI) stage B pre-cardiogenic shock (CS).Sixty patients with AHF without acute myocardial infarction with pre-CS, defined as systolic blood pressure (SBP)90 mmHg without hypoperfusion, venous lactate ≥2 mmol/L and/or mechanical or inotropic support, were randomized to istaroxime 1.0-1.5 μg/kg/min or placebo for 24 h. The primary endpoint, the adjusted area under the curve (AUC) change in SBP from time of treatment to 6 h, was 53.1 (standard error [SE] 6.88) mmHg × hour versus 30.9 (SE 6.76) mmHg × hour with istaroxime versus placebo (p = 0.017). Adjusted SBP AUC at 24 h was 291.2 (SE 27.5) versus 208.7 (SE 27.0) mmHg × hour (p = 0.025). At 24 h, some echocardiographic measurements improved with istaroxime versus placebo including cardiac index (+0.21 L/min/mIn a phase 2a study of patients with AHF related pre-CS, istaroxime improved blood pressure and some echocardiography measures related to heart failure and was well tolerated.

Aims Dyspnoea is the most common symptom leading to hospitalization for acute heart failure (AHF). Its early and persistent relief is an important goal of therapy, but little is known about its course, determinants, and prognostic significance. Methods and results In a post hoc analysis, we studied changes in dyspnoea and in-hospital course in 303 subjects with AHF enrolled in the PROTECT pilot trial. Changes in dyspnoea were assessed by patient self-report using a seven-point Likert scale daily to discharge and at Days 7 and 14. We defined dyspnoea relief as a moderate to marked improvement of dyspnoea at both 24 and 48 h, and treatment success as dyspnoea relief without worsening HF or renal function or death during the first 7 days. Dyspnoea relief occurred in 54% of the patients, while treatment success was achieved in 44% of the patients. By Day 14, only 75% of patients reported a moderate or marked improvement in dyspnoea. Both dyspnoea relief and treatment success were associated with greater improvement in signs of congestion, shorter hospitalization duration, and a lower 60-day mortality rate. Treatment success, but not dyspnoea relief, was also associated with a lower incidence of 60-day death or re-hospitalization for HF or renal failure. Conclusion Half of patients admitted for AHF do not have substantial improvement in dyspnoea at 24 h and 25% do not have substantial improvement at 7 and 14 days from admission. Dyspnoea relief and treatment success are associated with shorter length of stay and lower 60-day mortality. These analyses should be confirmed in larger studies.

A major limitation in acute heart failure (AHF) research has been the lack of an outcome measure paralleling re-infarction in acute coronary syndromes. The aim of the present study was to assess the time course, prognostic factors and outcome of early worsening heart failure (WHF) in patients admitted for AHF to a community hospital. All AHF admissions between December 2003 and March 2004 in a regional medical center were recorded. Patients were followed through admission and for 6 months after discharge. Early WHF was defined as WHF occurring during the initial 7 days from admission. Study endpoints were cardiovascular mortality and WHF (defined as worsening or persistent signs or symptoms of AHF requiring rescue therapy or hospital readmission). Early WHF rate was 29% and was associated with markers of AHF severity on presentation (higher troponin I, lower oxygen saturation, need for mechanical ventilation, intravascular diuretics and inotropes). Early WHF was a powerful predictor of death during 6 months of follow up, with an age-adjusted hazard ratio of 3.3 (95% confidence interval 1.7-6.3). Early WHF is a common adverse event in patients admitted with AHF, and is associated with AHF severity and excessive 6-month mortality. WHF should be considered as a clinically important endpoint in AHF studies.

Previous studies suggest that hyponatraemia is a marker of neurohormonal activation and increased mortality in patients with acute heart failure (AHF). Although diabetes is a common co-morbidity in heart failure, no prior study has considered the impact of serum glucose on this relationship. Methods: Over four consecutive months we prospectively registered all patients admitted due to AHF. Sodium and glucose levels were determined immediately upon admission. Patients were followed through admission and for the next 6 months. Of 342 patients enrolled, complete data were available for 331 patients. Results: Hyponatraemia (sodium

Background Although blood pressure (BP) is elevated in patients with acute heart failure (AHF), first admission BP has not been meticulously recorded before treatment in previous studies. Methods During three consecutive months, all AHF admissions (335 patients) to a city hospital which provides the sole inpatient medical service for approximately 500,000 people were registered. First BP was recorded before treatment at the first patient encounter in the ambulance or the emergency room. Results Mean BP at admission was 164±38/88±22 mm Hg. Mean BP in the highest quartile was 212±22/115±13 mm Hg. Patients with higher baseline BP had higher ejection fraction (highest versus lowest quartile 48±13% vs. 33±14%, p

Published investigations of the association between urinary tract infection (UTI) and preterm delivery used logistic regression or chi-squared tests. Because both exposure and outcome are time dependent, these methods were not optimal and did not account for person-time under observation, potentially an important feature given the variability of women's entry to prenatal care as well as of gestational lengths. Previous researchers probably classified as exposed some women whose UTI occurred after their pregnancies exceeded 37 weeks. We applied the previous analytical methods to 1990-93 births from two Durham, NC, USA, hospitals (n = 4053) and demonstrate survival methods as an alternative. Two logistic regression models were fitted with differing exposure definitions: model 1 in which exposed = UTI diagnosed after 20 weeks' gestation; and model 2 in which exposed = UTI diagnosed between 20 weeks' and 37 weeks' gestation. Model 3 used proportional hazards regression with person-time after 20 weeks and before UTI diagnosis as unexposed, and person-time after diagnosis as exposed. Models were fit with and without five time-constant potential confounders. Model 1 yielded an adjusted odds ratio (OR) of 0.8 [95% confidence interval (CI) 0.5, 1.2], and model 2, which did not include UTI diagnoses after 37 weeks, an adjusted OR of 0.9 [95% CI 0.6, 1.4]. The Cox model hazard ratio (HR) for preterm delivery was 1.1 (adjusted) [95% CI 0.7, 1.7]. As these results indicated some bias, but not remarkable differences, we conducted a sensitivity analysis using 100 samples of 80% of the original data set, with replacement to determine how large the differences might be in other, similar data sets. The Cox method consistently produced higher effect estimates than either logistic model. The two samples with the greatest differences between the Cox and logistic model estimates yielded an OR of 1.47 [95% CI 0.95, 2.29] for model 1 vs. HR of 2.06 [95% CI 1.39, 3.06] for model 3, and an OR of 1.41 [95% CI 0.88, 2.25] for model 2 vs. HR of 1.79 [95% CI 1.17, 2.71] for model 3 respectively. Previous published results on UTI and preterm delivery require cautious interpretation. Data on UTI timing should be gathered to allow appropriate analyses; survival methods account for person-time under observation and ensure that studied exposures precede effects.