Whether visit-to-visit blood pressure variability (BPV) is associated with adverse outcomes in patients with heart failure (HF) with preserved ejection fraction is unclear. We assessed these associations in 3184 patients with HF (51.0% women; mean age, 68.6 years) with preserved ejection fraction (≥45%) enrolled in the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist). BPV indexes were the SD, variability independent of the mean, and average real variability. The primary end point consisted of total mortality, myocardial infarction, stroke, and hospitalized HF. We computed hazard ratios for the risks associated with 1-SD increase in BPV indexes, using multivariable Cox regression to adjust for the BP level and confounders. In the placebo group (n=1577), the primary composite end point, stroke, and hospitalized HF were significantly associated with systolic and diastolic BPV (hazard ratios, ≥1.28; P ≤0.008) and total mortality with systolic BPV (hazard ratios ≥1.20; P ≤0.010). In the spironolactone group (n=1607), the primary end point and hospitalized HF were associated with both systolic and diastolic BPV (hazard ratios ≥1.17; P ≤0.006). Sensitivity analyses stratified by sex, median age, and region generated confirmatory results. Most of the interactions between randomized group and BPV indexes were not significant. In conclusion, in patients with HF with preserved ejection fraction, greater systolic and diastolic BPV were associated with adverse health outcomes over and beyond the BP level.

Objective: In patients with heart failure with preserved ejection fraction (HFpEF), whether living alone could contribute to a poor prognosis remains unknown. We sought to investigate the association of living alone with clinical outcomes in patients with HFpEF. Methods: Symptomatic patients with HFpEF with a follow-up of 3.3 years (data collected from August 2006 to June 2013) in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial were classified as patients living alone and those living with others. The primary outcome was defined as a composite of cardiovascular death, aborted cardiac arrest, or HF hospitalization. Results: A total of 3103 patients with HFpEF were included; 25.2% of them were living alone and were older, predominantly female, and less likely to be White and have more comorbidities compared with the other patients. After multivariate adjustment for confounders, living alone was associated with increased risks of HF hospitalization (hazard ratio [HR] = 1.29, 95% confidence interval [CI] = 1.03-1.61) and any hospitalization (HR = 1.26, 95% CI = 1.12-1.42). A significantly increased risk of any hospitalization (HR = 1.16, 95% CI = 1.01-1.34) was also observed in the Americas-based sample. In addition, each year increase in age, female sex, non-White race, New York Heart Association functional classes III and IV, dyslipidemia, and chronic obstructive pulmonary disease were independently associated with living alone. Conclusions: We assessed the effect of living arrangement status on clinical outcomes in patients with HFpEF and suggested that living alone was associated with an independent increase in any hospitalization. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT00094302.

Background: Liver dysfunction is prevalent in patients with heart failure (HF), but the prognostic significance of liver function tests (LFTs) remains controversial. Heart failure with preserved ejection fraction (HFpEF) had been introduced for some time, but no previous study had focused on LFTs in HFpEF. Thus, we aim to evaluate the prognostic significance of LFTs in well-defined HFpEF patients.Methods and Results: We conveyed a post-hoc analysis of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial (TOPCAT). The primary outcome was the composite of cardiovascular mortality, HF hospitalization, and aborted cardiac arrest, and the secondary outcomes were cardiovascular mortality and HF hospitalization. In Cox proportional hazards models, aspartate transaminase (AST) and alanine transaminase (ALT) were not associated with any of the outcomes. On the contrary, increases in total bilirubin (TBIL) and alkaline phosphatase (ALP) were associated with increased risks of the primary outcome [TBIL: adjusted hazard ratio (HR), 1.17; 95% confidence interval (CI) 1.08–1.26; ALP: adjusted HR, 1.12; 95% CI 1.04–1.21], cardiovascular mortality (TBIL: adjusted HR, 1.16; 95% CI 1.02–1.31; ALP: adjusted HR, 1.16; 95% CI 1.05–1.28), and HF hospitalization (TBIL: adjusted HR, 1.22; 95% CI 1.12–1.33; ALP: adjusted HR, 1.12; 95% CI 1.03–1.23).Conclusion: Elevated serum cholestasis markers TBIL and ALP were significantly associated with a poor outcome in HFpEF patients without chronic hepatic diseases, while elevated ALT and AST were not.

Background:The prognostic significance of blood urea nitrogen (BUN)/creatinine ratio specifically in chronic heart failure with preserved ejection fraction (HFpEF) patients remained unclear. We aimed to evaluate the association of BUN/creatinine ratio (baseline level and visit-to-visit variation) with the risk of adverse clinical outcomes among patients with chronic HFpEF. Methods and results: This is a secondary analysis of the Treatment of PreservedCardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial. Of the enrolled 3445 participants in the TOPCAT trial, associations between BUN/creatinine and clinical outcomes were examined in a subset of 1521 (baseline measurements level) and 1453 (visit-to-visit variation) participants. A multivariable Cox proportional hazard model was used to assess the prognostic significance of BUN/creatinine ratio and BUN/creatinine ratio variation for the prespecified clinical outcomes. A higher BUN/creatinine ratio was associated with a higher risk of all-cause mortality (hazard ratio [HR] = 1.52, 95%CI, 1.21-1.91; p < .001) as well as cardiovascular disease mortality (HR = 1.83, 95%CI, 1.35-2.49; p < .001) in the fully adjusted model. Greater visit-to-visit variability in BUN/creatinine ratio tended to be independently associated with a higher risk of heart failure hospitalization and primary endpoint (p < .001 for both outcomes). Furthermore, those findings were consistent across participants stratified by the presence of chronic kidney disease at baseline.