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Background: Patients hospitalized for acute heart failure experience poor health status, including a high burden of symptoms and physical limitations, and poor quality of life. SGLT2 (sodium-glucose cotransporter 2) inhibitors improve health status in chronic heart failure, but their effect on these outcomes in acute heart failure is not well characterized. We investigated the effects of the SGLT2 inhibitor empagliflozin on symptoms, physical limitations, and quality of life, using the Kansas City Cardiomyopathy Questionnaire (KCCQ) in the EMPULSE trial (Empagliflozin in Patients Hospitalized With Acute Heart Failure Who Have Been Stabilized)., Methods: Patients hospitalized for acute heart failure were randomized to empagliflozin 10 mg daily or placebo for 90 days. The KCCQ was assessed at randomization and 15, 30, and 90 days. The effects of empagliflozin on the primary end point of clinical benefit (hierarchical composite of all-cause death, heart failure events, and a 5-point or greater difference in KCCQ Total Symptom Score [TSS] change from baseline to 90 days) were examined post hoc across the tertiles of baseline KCCQ-TSS. In prespecified analyses, changes (randomization to day 90) in KCCQ domains, including TSS, physical limitations, quality of life, clinical summary, and overall summary scores were evaluated using a repeated measures model., Results: In total, 530 patients were randomized (265 each arm). Baseline KCCQ-TSS was low overall (mean [SD], 40.8 [24.0] points). Empagliflozin-treated patients experienced greater clinical benefit across the range of KCCQ-TSS, with no treatment effect heterogeneity (win ratio [95% CIs] from lowest to highest tertile: 1.49 [1.01-2.20], 1.37 [0.94-1.99], and 1.48 [1.00-2.20], respectively; P for interaction=0.94). Beneficial effects of empagliflozin on health status were observed as early as 15 days and persisted through 90 days, at which point empagliflozin-treated patients experienced a greater improvement in KCCQ TSS, physical limitations, quality of life, clinical summary, and overall summary (placebo-adjusted mean differences [95% CI]: 4.45 [95% CI, 0.32-8.59], P =0.03; 4.80 [95% CI, 0.00-9.61], P =0.05; 4.66 [95% CI, 0.32-9.01], P =0.04; 4.85 [95% CI, 0.77-8.92], P =0.02; and 4.40 points [95% CI, 0.33-8.48], P =0.03, respectively)., Conclusions: Initiation of empagliflozin in patients hospitalized for acute heart failure produced clinical benefit regardless of the degree of symptomatic impairment at baseline, and improved symptoms, physical limitations, and quality of life, with benefits seen as early as 15 days and maintained through 90 days., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT0415775.

Aims: Recovery of well-being after hospitalisation for acute heart failure (AHF) is a measure of the success of interventions and the quality of care but has rarely been quantified. Accordingly, we measured health status after discharge in an international registry (REPORT-HF) of AHF., Methods and Results: The analysis included 4606 patients with AHF who survived to hospital discharge, had known vital status at 6 months, and were enrolled in the United States of America, Russian Federation, or Western Europe, where the Kansas City Cardiomyopathy Questionnaire (KCCQ) was administered. Median age was 69 years (quartiles 59-78), 40% were women, and 34% had a left ventricular ejection fraction (LVEF) <40%, and 12% patients died by 6 months. Of 2475 patients with a follow-up KCCQ, 28% were 'alive and well' (KCCQ >75), while 43% had poor health status (KCCQ ≤50). Being 'alive and well' was associated with new-onset AHF, LVEF <40%, younger age, higher baseline KCCQ, country, and race. Associations were similar for increasing health status, with the exception of country and addition of comorbidities., Conclusion: In this international global registry, health status recovery after AHF hospitalisation was highly variable. Those with the best health status at 6 months were younger, had new-onset heart failure, and higher baseline KCCQ; nearly one-third of survivors were 'alive and well'. Investigating reasons for changes in KCCQ after hospitalisation might identify new therapeutic targets to improve patient-centred outcomes., (© 2022 European Society of Cardiology.)

Aims: Vitamin D deficiency is prevalent in heart failure (HF), but its relevance in early stages of heart failure with preserved ejection fraction (HFpEF) is unknown. We tested the association of 25-hydroxyvitamin D [25(OH)D] serum levels with mortality, hospitalizations, cardiovascular risk factors, and echocardiographic parameters in patients with asymptomatic diastolic dysfunction (DD) or newly diagnosed HFpEF., Methods and Results: We measured 25(OH)D serum levels in outpatients with risk factors for DD or history of HF derived from the DIAST-CHF study. Participants were comprehensively phenotyped including physical examination, echocardiography, and 6 min walk test and were followed up to 5 years. Quality of life was evaluated by the Short Form 36 (SF-36) questionnaire. We included 787 patients with available 25(OH)D levels. Median 25(OH)D levels were 13.1 ng/mL, mean E/e' medial was 13.2, and mean left ventricular ejection fraction was 59.1%. Only 9% (n = 73) showed a left ventricular ejection fraction <50%. Fifteen per cent (n = 119) of the recruited participants had symptomatic HFpEF. At baseline, participants with 25(OH)D levels in the lowest tertile (≤10.9 ng/L; n = 263) were older, more often symptomatic (oedema and fatigue, all P ≤ 0.002) and had worse cardiac [higher N-terminal pro-brain natriuretic peptide (NT-proBNP) and left atrial volume index, both P ≤ 0.023], renal (lower glomerular filtration rate, P = 0.012), metabolic (higher uric acid levels, P < 0.001), and functional (reduced exercise capacity, 6 min walk distance, and SF-36 physical functioning score, all P < 0.001) parameters. Increased NT-proBNP, uric acid, and left atrial volume index and decreased SF-36 physical functioning scores were independently associated with lower 25(OH)D levels. There was a higher risk for lower 25(OH)D levels in association with HF, DD, and atrial fibrillation (all P ≤ 0.004), which remained significant after adjusting for age. Lower 25(OH)D levels (per 10 ng/mL decrease) tended to be associated with higher 5 year mortality, P = 0.05, hazard ratio (HR) 1.55 [1.00; 2.42]. Furthermore, lower 25(OH)D levels (per 10 ng/mL decrease) were related to an increased rate of cardiovascular hospitalizations, P = 0.023, HR = 1.74 [1.08; 2.80], and remained significant after adjusting for age, P = 0.046, HR = 1.63 [1.01; 2.64], baseline NT-proBNP, P = 0.048, HR = 1.62 [1.01; 2.61], and other selected baseline characteristics and co-morbidities, P = 0.043, HR = 3.60 [1.04; 12.43]., Conclusions: Lower 25(OH)D levels were associated with reduced functional capacity in patients with DD or HFpEF and were significantly predictive for an increased rate of cardiovascular hospitalizations, also after adjusting for age, NT-proBNP, and selected baseline characteristics and co-morbidities., (© 2019 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

Background: Depression is more common in females than in males and is 3-5 times more prevalent in patients with heart failure (HF) than in the general population. The 9-item Patient Health Questionnaire (PHQ-9) is a validated depression screening instrument; higher sum-scores predict adverse clinical outcomes. Sex- and gender differences in PHQ-9 symptom profile, diagnostic and prognostic properties, and impact on health-related quality of life (HRQOL) have not been comprehensively studied in HF patients., Methods and Results: This post hoc analysis from the Interdisciplinary Network Heart Failure program enrolled 852/1022 participants (67 ± 13 years, 28% female) who completed the PHQ-9 at hospital discharge after cardiac decompensation. All had a left ventricular ejection fraction ≤ 40%. Women had a higher mean PHQ-9 sum-score than men (8.4 ± 5.6 vs. 7.4 ± 5.5; p = 0.027), and higher proportions rated the following items ≥ 2 (i.e., present on ≥ 50% of days): 'feeling down, hopeless' (25.8 vs. 18.0%; p = 0.011); 'fatigue' (51.9 vs. 37.2%; p < 0.001); and 'trouble concentrating' (21.6 vs. 15.4%; p = 0.032). A PHQ-9 sum-score ≥ 10 predicted increased mortality in women [hazard ratio 1.91 (95% confidence interval 1.06-3.43); p = 0.030] and men [2.10 (1.43-3.09); p < 0.001] and was associated with worse HRQOL (p < 0.001 for all comparisons). Sum-scores ≥ 10 predicted higher re-hospitalization rates in men only [1.35 (1.08-1.69); p = 0.008]., Conclusions: Differences in several PHQ-9 items indicated sex- or gender-specific depression symptomatology in HF. For both sexes, HRQOL and survival were worse when PHQ-9 sum-score was ≥ 10, but higher sum-scores predicted higher re-hospitalization rates in men only. Considering these specific aspects might help optimize care strategies in HF.

Background: Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States., Objective: MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland., Methods and Results: After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit., Conclusions: The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems., Trial Registration: ClinicalTrials.gov; NCT02693691.

Aims: Heart failure is known to profoundly affect health-related quality of life (HRQoL). We aimed to describe both generic and disease-specific HRQoL in a large community-based sample of patients with systolic heart failure (SHF) and to identify important somatic and psychosocial correlates., Methods and Results: Seven hundred and two patients, 67 ± 12 years old, 71 % men, with distributions of New York Heart Association (NYHA) functional classes I/II/III/IV of 2/55/39/4 % were included in this cross-sectional analysis. Generic HRQoL was measured with the SF-36 health survey, disease-specific HRQoL with the Kansas City Cardiomyopathy Questionnaire, and depression with the self-reported Patient Health Questionnaire (PHQ-9). Both generic- and disease-specific HRQoL measurements indicated moderate to poor HRQoL. The KCCQ scores demonstrated higher sensitivity to the varying levels of heart failure severity as compared to the SF-36 scores. Patients with either a minor (15 %) or a major depression (24 %) reported significantly and substantially lower HRQoL (p < .001) than patients without depression did. In multivariable regression analyses, depression accounted for the largest part of the variance of both generic and specific HRQoL (12 and 36 %, respectively), whereas most biomedical variables had no or only a marginal influence., Conclusion: Patients with SHF suffer from severe limitations of HRQoL. Depression was the most important correlate of both generic and disease-specific HRQoL.

Background: Depression is highly prevalent in patients with chronic heart failure (CHF) and may bias patients' reports of their health-related quality of life (HRQoL). Depressed patients may rate their limitations of HRQoL worse even when their condition is rather good. We aimed to examine whether co-morbid depression alters the relationship between disease severity and HRQoL, thus compromising the validity of a CHF-specific HRQoL measure., Methods: A sample of 233 outpatients with CHF (mean age 64.5 years, 70% male) was evaluated. Depression was measured with the Patient Health Questionnaire and CHF-specific HRQoL with the Kansas City Cardiomyopathy Questionnaire (KCCQ). CHF severity was assessed with physician ratings of the New York Heart Association (NYHA) functional class., Results: Both NYHA functional class and depression independently impacted the various subscales of the KCCQ. Regarding the symptom- and function-related subscales, a dose-response relationship between disease severity and HRQoL was observed also in depressed patients. In contrast, in the quality of life subscale covering life satisfaction an interaction effect of disease severity and depression was found. In this subscale, a dose-response relationship between increasing disease severity and worsening HRQoL was no longer present among the depressed., Conclusions: Both disease severity and depression impacted each heart failure-specific HRQoL dimension while the presence of depression seemed to distort the relationship between disease severity and HRQoL in the quality of life subscale. As quality of life may depend more on the presence of depression than on the severity of CHF, assessing depression may help interpreting HRQoL scores., (Copyright (c) 2008 Elsevier Ireland Ltd. All rights reserved.)

Background: To examine whether depression and heart failure severity are independent predictors of both the physical and psychologic domains of health-related quality of life (HRQoL) in patients with chronic heart failure., Methods and Results: A sample of 206 outpatients with chronic heart failure (mean age 64 years, 69% male) was evaluated. Depression was measured with the Patient Health Questionnaire and disease-specific HRQoL with the Kansas City Cardiomyopathy Questionnaire. Heart failure severity was assessed with physician ratings of the New York Heart Association (NYHA) functional class. The simultaneous effects of predictor variables on outcomes were estimated using structural equation modeling. Both depression and NYHA functional class independently predicted the physical domain of HRQoL. By contrast, the psychologic domain was only predicted by depression, but not by NYHA functional class., Conclusions: Our results suggest that comorbid depression has an independent impact on both physical and psychologic HRQoL in patients with chronic heart failure after controlling for the severity of heart failure symptoms, while heart failure severity only impacts physical HRQoL. Thus, assessment of comorbid depression may help interpreting reduced HRQoL in heart failure patients. Research seems warranted evaluating whether the amelioration of depression may enhance patients' HRQoL in chronic heart failure.

Objective: The aim of this study was to examine whether the physical and mental components of health-related quality of life (HRQoL) are independent predictors of survival in patients with chronic heart failure (CHF)., Methods: A cohort of 231 outpatients with CHF was followed prospectively for 986 days (median; interquartile range=664-1120). Generic HRQoL was measured with the Short Form-36 Health Survey (SF-36), disease-specific HRQoL was measured with the Kansas City Cardiomyopathy Questionnaire, and depression was measured with the self-reported Patient Health Questionnaire., Results: Both generic and disease-specific HRQoL were predictive of survival on univariate analyses. After adjustment for prognostic factors such as age, gender, degree of left ventricular dysfunction, and functional status, only the mental health component of SF-36 and the disease-specific HRQoL remained significant. When depression was included, both measures also lost their predictive power., Conclusion: Our data suggest that the prognostic value of patients' HRQoL reflects confounding with the severity of disease and comorbid depression.

Patients' health-related quality of life is increasingly being included as an additional endpoint when evaluating the treatment of chronic heart failure. Although generic self-report instruments measuring health-related quality of life are available, there is a lack of disease-specific instruments covering various dimensions of quality of life with high reliability, validity and sensitivity to chance. Thus, the aim of the present study was to evaluate the German version of a new heart failure-specific quality of life measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ). The sample consisted of 233 consecutively recruited outpatients of a university department in Germany. Test-retest-reliability was high (intraclass correlation coefficient 0.93 for both the Functional State and the Clinical Summary total scores). Construct validity was demonstrated with strong correlations to respective subscales of the SF-36. Known groups validity was shown by both statistically and clinically significant differences between NYHA classes. The examination of sensitivity to change yielded promising results. The questionnaire was well accepted by the participating patients. The KCCQ proved to be a reliable and valid self-report instrument for measuring disease-specific quality of life in chronic heart failure.

Aims: Heart failure (HF) leads to repeat hospitalisations and reduces the duration and quality of life. Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS™ HF system was shown to be safe and reduce HF hospitalisation (HFH) rates in New York Heart Association (NYHA) class III patients. However, these findings have not been replicated in health systems outside the United States. Therefore, the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) evaluated the safety, feasibility, and performance of this device in Germany, The Netherlands, and Ireland.Methods and Results: A total of 234 NYHA class III patients (68 ± 11 years, 22% female, ≥1 HFH in the preceding year) from 31 centres were implanted with a CardioMEMS sensor and underwent PAP-guided HF management. One-year rates of freedom from device- or system-related complications and from sensor failure (co-primary outcomes) were 98.3% [95% confidence interval (CI) 95.8-100.0] and 99.6% (95% CI 97.6-100.0), respectively. Survival rate was 86.2%. For the 12 months post- vs. pre-implant, HFHs decreased by 62% (0.60 vs. 1.55 events/patient-year; hazard ratio 0.38, 95% CI 0.31-0.48; P < 0.0001). After 12 months, mean PAP decreased by 5.1 ± 7.4 mmHg, Kansas City Cardiomyopathy Questionnaire (KCCQ) overall/clinical summary scores increased from 47.0 ± 24.0/51.2 ± 24.8 to 60.5 ± 24.3/62.4 ± 24.1 (P < 0.0001), and the 9-item Patient Health Questionnaire sum score improved from 8.7 ± 5.9 to 6.3 ± 5.1 (P < 0.0001).Conclusion: Haemodynamic-guided HF management proved feasible and safe in the health systems of Germany, The Netherlands, and Ireland. Physician-directed treatment modifications based on remotely obtained PAP values were associated with fewer HFH, sustainable PAP decreases, marked KCCQ improvements, and remission of depressive symptoms. [ABSTRACT FROM AUTHOR]

Aims The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure ( HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF (International REgistry to assess medical Practice with lOngitudinal obseRvation for Treatment of Heart Failure) is a global, prospective, and observational study designed to characterize patient trajectories longitudinally during and following an index hospitalization for HF. Methods Data collection for the registry will be conducted at ∼300 sites located in ∼40 countries. Comprehensive data including demographics, clinical presentation, co-morbidities, treatment patterns, quality of life, in-hospital and post-discharge outcomes, and health utilization and costs will be collected. Enrolment of ∼20 000 adult patients hospitalized with new-onset (first diagnosis) HF or decompensation of chronic HF over a 3-year period is planned with subsequent 3 years follow-up. Perspective The REPORT-HF registry will explore the clinical characteristics, management, and outcomes of HF worldwide. This global research programme may have implications for the formulation of public health policy and the design and conduct of international clinical trials. [ABSTRACT FROM AUTHOR]

Background Heart failure ( HF) pharmacotherapy is often not prescribed according to guidelines. This longitudinal study investigated prescription rates and dosages of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACEi/ ARB), beta-blockers, and mineralocorticoid receptor antagonists ( MRA), and concomitant changes of symptoms, echocardiographic parameters of left ventricular ( LV) function and morphology and results of the Short Form-36 ( SF-36) Health Survey in participants of the Interdisciplinary Network Heart Failure ( INH) programme. Methods and results The INH study evaluated a nurse-coordinated management, HeartNetCare-HFTM ( HNC), against Usual Care ( UC) in patients hospitalized for decompensated HF [ LV ejection fraction ( LVEF) ≤40% before discharge). A total of 706 subjects surviving >18 months (363 UC, 343 HNC) were examined 6-monthly. At baseline, 92% received ACEi/ ARB, ( HNC/ UC 91/93%, P = 0.28), 86% received beta-blockers (86/86%, P = 0.83), and 44% received MRA (42/47%, P = 0.07). After 18 months, beta-blocker use had increased only in HNC (+7.6%, P < 0.001). Guideline-recommended target doses were achieved more frequently in HNC for ACEi/ ARB ( HNC/ UC: 50/25%, P < 0.001) and beta-blockers (39/15%, P < 0.001). The following variables were more improved and/or better in subjects undergoing HNC compared with UC: LVEF (47 ± 12 vs. 44 ± 12%, P = 0.004, change +17/+14%, P = 0.010), LV end-diastolic diameter (59 ± 9 vs. 61 ± 9.6 mm, P = 0.024, change −2.3/-1.4mm, P = 0.13), New York Heart Association class (1.9 ± 0.7 vs. 2.1 ± 0.7, P = 0.001, change −0.44/-0.25, P = 0.002) and SF-36 physical component summary score (41.6 ± 11.2 vs. 38.5 ± 11.8, P = 0.004, change +3.3 vs. +1.1 score points, P < 0.02). Conclusions Prescription rates and dosages of ACEi/ ARB and beta-blockers improved more in HNC than UC patients. Concomitantly, participation in HNC was associated with significantly better clinical outcomes and more favourable echocardiographic changes after 18 months. [ABSTRACT FROM AUTHOR]

The article discusses a study on mode of action and effects of standardized collaborative disease management on mortality and morbidity in patients with systolic heart failure. It states that multidisciplinary disease management programs may bridge the gap between existing therapeutic options and clinical practice considering that European and U.S. surveys showed implementation of evidence-based therapies is fragmentary. The results showed that death occurred more often in usual care (UC).

Abstract: Background: Depression and chronic heart failure (CHF) are common conditions, both of which are clinically and economically highly relevant. Major depression affects 20–40% of CHF patients and predicts adverse outcomes in terms of quality of life, morbidity and mortality as well as health care expenditure, independent of other factors of prognostic relevance. Aims: The purpose of the MOOD-HF trial is to clarify whether antidepressant pharmacotherapy improves outcome in CHF patients, and if so by which mechanism(s). Methods: MOOD-HF is a prospective, randomised, double-blind, placebo-controlled, 2-armed, parallel-group multicenter trial investigating the effects of the serotonin re-uptake inhibitor (SSRI) escitalopram on morbidity and mortality (primary endpoint), severity of depression, anxiety, cognitive function, quality of life and health care expenditure in 700 patients with symptomatic systolic CHF and major depression diagnosed by structured clinical interview. All patients will receive optimised pharmacotherapy for CHF. Duration of follow-up, including close safety monitoring, is 12–24 months from randomisation. Perspective: MOOD-HF is the first prospective randomised controlled trial to assess the effects of antidepressant pharmacotherapy on hard somatic endpoints, the mechanism(s) of action of SSRI treatment, as well as safety in New York Heart Association functional class II-IV CHF patients. The results are expected to promote the development of evidence-based recommendations for managing depression in the context of CHF. Trial registration: ISRCTN.org. Identifier: ISRCTN33128015 [Copyright &y& Elsevier]

Abstract: Aims: Depression is common in heart failure (HF) and associated with adverse outcomes. This study aimed to investigate incidence rates and predictors of depression in patients sampled from four subprojects of the German Competence Network Heart Failure. Methods: Eight hundred thirty nine symptomatic HF patients free of depression at baseline underwent repeat depression screening (Patient Health Questionnaire, PHQ-9) after 12months. Ordered logistic regression analysis was employed to search for predictors of incident depression. Results: Incident minor (major) depression was observed in 61 (7.3%) and 47 (5.6%) of the population. Depression was recurrent in 15 (25%) and 16 (34%), respectively. Multiple regression analysis revealed seven variables predicting minor or major depression: Previous depressive episode (odds ratio [OR] 4.04, 95% confidence interval [CI] 2.37–6.89, p ≤0.001), previous resuscitation (OR 2.44, CI 1.23–4.81, p =0.010), current smoking (OR 2.06, CI 1.08–3.50, p =0.008), >4 visits/year to general practitioner (OR 1.67, CI 1.06–2.63, p =0.026), New York Heart Association class (OR 1.54/class, 95% CI 1.05–2.25, p =0.027), PHQ-9 baseline sum-score (OR 1.18/point, CI 1.11–1.27, p <0.001), and SF-36 physical functioning (OR 1.08/−5 points, CI 1.03–1.13, p =0.002). Conclusions: In these HF patients initially free of depression annual incidence rates were high. Several independent predictors allowed identification of patients at particular risk. Although obtained in a selected cohort these findings call, in view of the grave prognosis of HF patients with comorbid depression, for regular depression screening and development of specific supportive strategies to improve patient care and outcomes in HF. [Copyright &y& Elsevier]