Abstract 13: Advance Directives in Heart Failure Patients

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Shannon M Dunlay ◽  
Paul S Mueller ◽  
Keith M Swetz ◽  
Veronique L Roger
Keyword(s):  
Heart Failure ◽  
Health Status ◽  
End Of Life ◽  
Advance Directives ◽  
Kansas City ◽  
Functional Class ◽  
Artificial Nutrition ◽  
Older Individuals ◽  
Nyha Functional Class ◽  
Health Status Questionnaires

Background: Heart failure (HF) has an overall poor prognosis, with only half of patients surviving more than 5 years after diagnosis. Although it is recommended that all patients with HF have advance directives (ADs) in place before the end of life is imminent, the use of ADs in these patients has not been well studied. Methods: We prospectively enrolled all Olmsted County residents presenting with active HF from October 2007 through October 2011 into a longitudinal community cohort study which included an echocardiogram and administration of health status questionnaires at enrollment. Information from ADs completed prior to enrollment was manually abstracted from the patient’s medical record. Results: A total of 608 patients were enrolled during the study period (mean age 74.0 years, 54.9% male, 49.9% with preserved EF [EF≥50%], 65.3% NYHA functional class 3 or 4). Mortality was high; 164 (27.0%) patients died after a mean follow-up of 1.8 years with estimated 1-year mortality of 14.3%. At the time of enrollment, only 249 (41.0%) patients had ADs, and they were completed an average of 3.3 years prior. Although most ADs appointed a proxy decision-maker (91.1%), less than half addressed patient wishes regarding use of cardiopulmonary resuscitation (41.4%), mechanical ventilation (38.7%), administration of artificial nutrition (38.6%), or hemodialysis (10.0%) at the end of life. AD use was more common in older individuals (p<0.001); 60.7% of those ≥80 years had an AD vs. 13.6% of those who were <60 years old. While ADs were more common in women than men (46.7% vs. 36.2%, respectively) and in those with preserved EF (47.2% vs. 34.0% in those with reduced EF), differences were not significant after adjustment for age. AD use was no more common in patients with worse NYHA functional class or health status as measured by the Kansas City Cardiomyopathy Questionnaire. Conclusions: Despite a high mortality rate, over half of community patients with HF do not have ADs, and existing AD fail to address important medical decisions common at the end of life. Further work is needed to identify potential barriers to AD use in HF patients, and to determine whether their use has any impact on patient outcomes, including end of life resource utilization.

Abstract P230: An Observational Study of Deployment of American Heart Association Heart Failure Protocols and Educational Content Within the Intel® Health Guide System Post Discharge

2011 ◽  
Vol 4 (suppl_2) ◽  
Author(s):  
Ileana L Pina ◽  
Nancy M Albert ◽  
Gregg M Fonarow ◽  
Gloria Catha ◽  
Patrick Wayte ◽  
...  
Keyword(s):  
Heart Failure ◽  
Health Status ◽  
Observational Study ◽  
Kansas City ◽  
Clinical Status ◽  
Class Iii ◽  
Educational Content ◽  
Post Discharge ◽  
Rehospitalization Rate ◽  
Guide System

Background: Telemonitoring (Tel) of heart failure (HF) patients (pts) post discharge has had variable results. However, Tel systems have not always integrated delivery of relevant pt education. The purpose of this study was to examine outcomes after implementation of the Intel Health Guide System (HGS). HGS was deployed with AHA guideline-based HF protocols for clinical status, symptoms and delivery of relevant pt education to enhance pts’ understanding of and management of HF. Methods: Twenty-six pts post discharge with a HF diagnosis were enrolled. Based on the pts’ clinical status, AHA-HF protocols were deployed into the HGS to assess key vital signs and health questions daily, weekly, or monthly for 60 days. Pts and caregivers were trained in use of the HGS and related peripherals, response to scheduled sessions, and access of educational content independent of scheduled sessions. Health status was assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) pre and post monitoring. Results: Of 26 pts, 62% NYHA were Class II, 29% Class III. Mean age 75.2 ±10.1 yrs; 62% women; 39% African Americans; 23% ischemic. Mean EF = 47% ±16. Adherence was 88%. KCCQ Clinical and Overall scores increased significantly from 49±25 and 51±23 to 63±26 and 65±22, respectively (p=0.039). Thirteen pts (50%) were rehospitalized at mean of 16+5 days, 4 for HF and 9 for other reasons, (30 day rehospitalization rate = 23% all cause; 15% for HF). Median compliance (completing scheduled sessions) and utility (days with activity/monitored) for those not rehospitalized were greater (97.2%, 96.9%) than for those rehospitalized (67.4%, 82.6%; p=0.013, p=0.005, respectively). Using generalized estimating equations, greater utility but not compliance correlated with better health status’ clinical (p=0.013) and overall scores (p=0.0056). Conclusions: This observational study showed feasibility of adding AHA-HF guideline protocols and education content to the HGS. Health status improved post discharge. Although the rehospitalization rate was > 20%, pts who were not readmitted were more likely to have greater Tel utility and compliance. In addition, clinical and overall health status measures improved during the study, and were associated with greater pt utilization of the system.

Abstract 11916: Changes in Symptoms Predicted Changes in Health-Related Quality of Life in Patients With Heart Failure

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Seongkum Heo ◽  
Debra K Moser ◽  
Terry A Lennie ◽  
Mary Fischer ◽  
Eugene Smith ◽  
...  
Keyword(s):  
Heart Failure ◽  
Self Care ◽  
Physical Symptoms ◽  
Functional Class ◽  
Nyha Functional Class ◽  
Behavioral Variables ◽  
Patients With Heart Failure ◽  
Related Quality ◽  
Health Related

Background: Patients with heart failure (HF) have notably poor health-related quality of life (HRQOL), which is associated with high hospitalization rates. Physical symptoms have been associated with poor HRQOL. However, whether improvement in physical symptoms actually leads to improvement in HRQOL has not fully examined in patients with HF. Purpose: To examine the effects of changes in physical symptoms on changes in HRQOL at 12 months, after controlling for age, comorbidities, New York Heart Association (NYHA) functional class, and modifiable psychosocial and behavioral factors. Methods: Data on physical symptoms (Symptom Status Questionnaire-HF) and HRQOL (Minnesota Living with Heart Failure) were collected from 94 patients with HF (mean age 58 ± 14 years, 44% male, 58% NYHA functional class II/III) at baseline and 12 month follow-up. Age, comorbidities, and NYHA functional class were collected using standard questionnaires at baseline. Psychosocial variables (depressive symptoms [Patient Health Questionnaire], perceived control [Control Attitudes Scale-Revised], and social support [Multidimensional Scale of Perceived Social Support]) and behavioral variables (medication adherence [Micro-Electro-Mechanical Systems], sodium intake [24-hour urine], and self-care management [Self-care management subscale of the Self-Care of Heart Failure Index]) were collected at baseline. Hierarchical multiple regression analyses were used to analyze the data. Results: The mean score changes in physical symptoms and HRQOL were -3.8 (± 14.1) and -9.2 (± 24.1), respectively (negative scores indicate improvement.). Among the sociodemographic and clinical characteristics, psychosocial variables, behavioral variables, baseline physical symptoms, and changes in physical symptoms, only changes in physical symptoms predicted changes in HRQOL at 12 months (F = 6.384, R2 = .46, p < .001). Improvement in physical symptoms led to improvement in HRQOL. Conclusion: It is critical to improve physical symptoms to improve HRQOL. Thus, development and delivery of effective interventions targeting improvement in physical symptoms are warranted in this population.

scholarly journals Use of Free-Living Step Count Monitoring for Heart Failure Functional Classification: Validation Study (Preprint)

2018 ◽  
Author(s):  
Jonathan-F. Baril ◽  
Simon Bromberg ◽  
Yasbanoo Moayedi ◽  
Babak Taati ◽  
Cedric Manlhiot ◽  
...  
Keyword(s):  
Heart Failure ◽  
Pilot Study ◽  
Ejection Fraction ◽  
Functional Class ◽  
Step Count ◽  
Functional Classification ◽  
Free Living ◽  
Reduced Ejection Fraction ◽  
Nyha Functional Class ◽  
Daily Total

BACKGROUND The New York Heart Association (NYHA) functional classification system has poor inter-rater reproducibility. A previously published pilot study showed a statistically significant difference between the daily step counts of heart failure (with reduced ejection fraction) patients classified as NYHA functional class II and III as measured by wrist-worn activity monitors. However, the study’s small sample size severely limits scientific confidence in the generalizability of this finding to a larger heart failure (HF) population. OBJECTIVE This study aimed to validate the pilot study on a larger sample of patients with HF with reduced ejection fraction (HFrEF) and attempt to characterize the step count distribution to gain insight into a more objective method of assessing NYHA functional class. METHODS We repeated the analysis performed during the pilot study on an independently recorded dataset comprising a total of 50 patients with HFrEF (35 NYHA II and 15 NYHA III) patients. Participants were monitored for step count with a Fitbit Flex for a period of 2 weeks in a free-living environment. RESULTS Comparing group medians, patients exhibiting NYHA class III symptoms had significantly lower recorded 2-week mean daily total step count (3541 vs 5729 [steps], P=.04), lower 2-week maximum daily total step count (10,792 vs 5904 [steps], P=.03), lower 2-week recorded mean daily mean step count (4.0 vs 2.5 [steps/minute], P=.04,), and lower 2-week mean and 2-week maximum daily per minute step count maximums (88.1 vs 96.1 and 111.0 vs 123.0 [steps/minute]; P=.02 and .004, respectively). CONCLUSIONS Patients with NYHA II and III symptoms differed significantly by various aggregate measures of free-living step count including the (1) mean and (2) maximum daily total step count as well as by the (3) mean of daily mean step count and by the (4) mean and (5) maximum of the daily per minute step count maximum. These findings affirm that the degree of exercise intolerance of NYHA II and III patients as a group is quantifiable in a replicable manner. This is a novel and promising finding that suggests the existence of a possible, completely objective measure of assessing HF functional class, something which would be a great boon in the continuing quest to improve patient outcomes for this burdensome and costly disease.

scholarly journals Prognostic Value of Combination of Cardiac Troponin T and B-Type Natriuretic Peptide after Initiation of Treatment in Patients with Chronic Heart Failure

2003 ◽  
Vol 49 (12) ◽  
pp. 2020-2026 ◽  
Author(s):  
Junnichi Ishii ◽  
Wei Cui ◽  
Fumihiko Kitagawa ◽  
Takahiro Kuno ◽  
Yuu Nakamura ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Cardiac Troponin ◽  
Troponin T ◽  
Myocardial Damage ◽  
Left Ventricular ◽  
Functional Class ◽  
Cardiac Troponin T ◽  
Cardiac Events ◽  
Nyha Functional Class

Abstract Background: Recent studies have suggested that cardiac troponin T (cTnT) and troponin I may detect ongoing myocardial damage involved in the progression of chronic heart failure (CHF). This study was prospectively designed to examine whether the combination of cTnT, a marker for ongoing myocardial damage, and B-type natriuretic peptide (BNP), a marker for left ventricular overload, would effectively stratify patients with CHF after initiation of treatment. Methods: We measured serum cTnT, plasma BNP, and left ventricular ejection fraction (LVEF) on admission for worsening CHF [New York Heart Association (NYHA) functional class III to IV] and 2 months after initiation of treatment to stabilize CHF (n = 100; mean age, 68 years). Results: Mean (SD) concentrations of cTnT [0.023 (0.066) vs 0.063 (0.20) μg/L] and BNP [249 (276) vs 753 (598) ng/L], percentage increased cTnT (&gt;0.01 μg/L; 35% vs 60%), NYHA functional class [2.5 (0.6) vs 3.5 (5)], and LVEF [43 (13)% vs 36 (12)%] were significantly (P &lt;0.01) improved 2 months after treatment compared with admission. During a mean follow-up of 391 days, there were 44 cardiac events, including 12 cardiac deaths and 32 readmissions for worsening CHF. On a stepwise Cox regression analysis, increased cTnT and BNP were independent predictors of cardiac events (P &lt;0.001). cTnT &gt;0.01 μg/L and/or BNP &gt;160 ng/L 2 months after initiation of treatment were associated with increased cardiac mortality and morbidity rates. Conclusion: The combination of cTnT and BNP measurements after initiation of treatment may be highly effective for risk stratification in patients with CHF.

scholarly journals Increased Interleukin-11 Levels Are Correlated with Cardiac Events in Patients with Chronic Heart Failure

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Jing Ye ◽  
Zhen Wang ◽  
Di Ye ◽  
Yuan Wang ◽  
Menglong Wang ◽  
...  
Keyword(s):  
Heart Failure ◽  
Plasma Concentrations ◽  
Heart Association ◽  
Functional Class ◽  
Control Group ◽  
Class Iii ◽  
Cardiac Events ◽  
Nyha Functional Class ◽  
Interleukin 11

Background. Interleukin-11 (IL-11) is an important inflammatory cytokine and has been demonstrated to participate in cardiovascular diseases. However, there have been no studies about the role of IL-11 in heart failure (HF). The present study is aimed at investigating whether IL-11 levels are associated with the cardiac prognosis in patients with HF. Methods. The plasma concentrations of IL-11 were measured in 240 patients with chronic HF (CHF) and 80 control subjects without signs of significant heart disease. In addition, we prospectively followed these CHF patients to endpoints of cardiac events. Results. Compared with the control group, the plasma IL-11 concentrations were significantly increased in the CHF patients and gradually increased in the New York Heart Association (NYHA) functional class II group, the NYHA functional class III group, and the NYHA functional class IV group. The receiver operating characteristic (ROC) curve revealed that the predictive role of IL-11 in HF is not as good as N-terminal B-type natriuretic peptide (BNP), although IL-11 has a certain value in predicting cardiac events. In addition, the CHF patients were divided into 3 groups according to the plasma IL-11 concentration category (low, T1; middle, T2; and high, T3). The multivariate Cox hazard analysis showed that the high plasma IL-11 concentrations were independently associated with the presence of cardiac events after adjustment for confounding factors. Furthermore, the CHF patients were divided into two groups based on the median plasma IL-11 concentrations. The Kaplan-Meier analysis revealed that the patients with high IL-11 concentrations had a higher risk of cardiac events compared with those with low IL-11 concentrations. Conclusions. Higher plasma IL-11 levels significantly increase the presence of cardiac events and suggest a poor outcome; although the diagnostic value of IL-11 in CHF is not as good as BNP, there is a certain value in predicting cardiac events in CHF.

P2607Quick nutritional assessment and prognosis in outpatients with heart failure with mid-range ejection fraction

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Zamora ◽  
B Gonzalez ◽  
C Rivas ◽  
V Diaz ◽  
P Velayos ◽  
...  
Keyword(s):  
Heart Failure ◽  
Body Mass Index ◽  
At Risk ◽  
Ejection Fraction ◽  
Nutritional Status ◽  
Body Mass ◽  
Screening Tool ◽  
Nutritional Assessment ◽  
Functional Class ◽  
Nyha Functional Class

Abstract Background Nutritional status is an important prognostic factor in patients with heart failure (HF) beyond body mass index, although its prognostic value in patients with mid-range left ventricular ejection fraction (HFmrEF) is not completely elucidated. In a pilot study we observed that the Mini Nutritional Assessment Short Form (MNA-SF) was the best approach for the screening of nutritional status in HF outpatients over others screening tools. Purpose To assess the prognostic role of malnutrition or risk of malnutrition in HFmrEF outpatients after the implementation of the MNA-SF screening tool in a routine way in a multidisciplinary HF. Methods The MNA-SF screening tool was administered during the global nurse evaluation of patients. The scoring ranges from 0 to 14, being 0 to7 as malnutrition status, 8 to 11 as at risk of malnutrition and 12 to 14 as normal nutritional status. For the present study those patients with malnutrition and at risk of malnutrition were merged and considered abnormal nutritional status. All-cause death was the primary end-point. Univariate and multivariate (backward conditional stepwise) Cox regression analyses were performed. Results Since October 2016 to November 2017, 153 HFmrEF patients were studied (mean age 68.8±11.7 years, 72.5% men, body mass index 28.4±4.4, LVEF 44% ± 3, NYHA class I 5.9%, II 86.3%, and III 7.8%). According to the MNA-SF 25 patients were (16.3%) fulfilled criteria of malnutrition (4) or where at risk of malnutrition (21). During a mean follow-up of 17.4±6.1 months, 23 patients died (15%). In the univariate analysis, nutritional abnormal status was significantly associated with all-cause death (HR 2.93 [1.23–7], p=0.02). In the multivariate analysis which included age, sex, NYHA functional class, body mass index, ischemic aetiology of HF and years of duration of HF, abnormal nutritional status remained significantly associated with all-cause mortality (HR 3.64 [1.39–9.54], p=0.009), together with NYHA functional class (HR 7.93 [2.69–23.4], p<0.001) and years of HF duration (HR 1.10 [1.04–1.16], p=0.001). Conclusions Nutritional status assessed with the screening MNA-SF was an independent predictor of all-cause death in ambulatory patients with HFmrEF – beyond BMI – together with NYHA functional class and HF duration.

scholarly journals Association of Cardiac Biomarkers With the Kansas City Cardiomyopathy Questionnaire in Patients With Chronic Kidney Disease Without Heart Failure

2020 ◽  
Vol 9 (13) ◽  
Author(s):  
Sri Lekha Tummalapalli ◽  
Leila R. Zelnick ◽  
Amanda H. Andersen ◽  
Robert H. Christenson ◽  
Christopher R. deFilippi ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Kidney Disease ◽  
Health Status ◽  
Kidney Disease ◽  
Kansas City ◽  
Troponin T ◽  
Cardiac Biomarkers ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Galectin 3 ◽  
Multivariable Adjustment

Background The Kansas City Cardiomyopathy Questionnaire ( KCCQ ) is a measure of heart failure ( HF ) health status. Worse KCCQ scores are common in patients with chronic kidney disease ( CKD ), even without diagnosed heart failure ( HF ). Elevations in the cardiac biomarkers GDF‐15 (growth differentiation factor‐15), galectin‐3, sST2 (soluble suppression of tumorigenesis‐2), hsTnT (high‐sensitivity troponin T), and NT ‐pro BNP (N‐terminal pro‐B‐type natriuretic peptide) likely reflect subclinical HF in CKD . Whether cardiac biomarkers are associated with low KCCQ scores is not known. Methods and Results We studied participants with CKD without HF in the multicenter prospective CRIC (Chronic Renal Insufficiency Cohort) Study. Outcomes included (1) low KCCQ score <75 at year 1 and (2) incident decline in KCCQ score to <75. We used multivariable logistic regression and Cox regression models to evaluate the associations between baseline cardiac biomarkers and cross‐sectional and longitudinal KCCQ scores. Among 2873 participants, GDF‐15 (adjusted odds ratio 1.42 per SD ; 99% CI , 1.19–1.68) and galectin‐3 (1.28; 1.12–1.48) were significantly associated with KCCQ scores <75, whereas sST2, hsTnT, and NT ‐pro BNP were not significantly associated with KCCQ scores <75 after multivariable adjustment. Of the 2132 participants with KCCQ ≥75 at year 1, GDF‐15 (adjusted hazard ratio, 1.36 per SD ; 99% CI , 1.12–1.65), hsTnT (1.20; 1.01–1.44), and NT ‐pro BNP (1.30; 1.08–1.56) were associated with incident decline in KCCQ to <75 after multivariable adjustment, whereas galectin‐3 and sST2 did not have significant associations with KCCQ decline. Conclusions Among participants with CKD without clinical HF , GDF‐15, galectin‐3, NT ‐pro BNP , and hsTnT were associated with low KCCQ either at baseline or during follow‐up. Our findings show that elevations in cardiac biomarkers reflect early symptomatic changes in HF health status in CKD patients.

scholarly journals Clinical Predictors Influencing the Length of Stay in Emergency Department Patients Presenting with Acute Heart Failure

Medicina ◽  
2020 ◽  
Vol 56 (9) ◽  
pp. 434
Author(s):  
Pungkava Sricharoen ◽  
Phichayut Phinyo ◽  
Jayanton Patumanond ◽  
Dilok Piyayotai ◽  
Yuwares Sittichanbuncha ◽  
...  
Keyword(s):  
Heart Failure ◽  
Emergency Department ◽  
Length Of Stay ◽  
Acute Heart Failure ◽  
Multivariable Analysis ◽  
Heart Association ◽  
Functional Class ◽  
Class Iii ◽  
Clinical Predictors ◽  
Nyha Functional Class

Background and objectives: Acute heart failure is a common problem encountered in the emergency department (ED). More than 80% of the patients with the condition subsequently require lengthy and repeated hospitalization. In a setting with limited in-patient capacity, the patient flow is often obstructed. Appropriate disposition decisions must be made by emergency physicians to deliver effective care and alleviate ED overcrowding. This study aimed to explore clinical predictors influencing the length of stay (LOS) in patients with acute heart failure who present to the ED. Materials and Methods: We conducted prognostic factor research with a retrospective cohort design. Medical records of patients with acute heart failure who presented to the ED of Ramathibodi Hospital from January to December 2015 were assessed for eligibility. Thirteen potential clinical predictors were selected as candidates for statistical modeling based on previous reports. Multivariable Poisson regression was used to estimate the difference in LOS between patients with and without potential predictors. Results: A total of 207 patients were included in the analysis. Most patients were male with a mean age of 74.2 ± 12.5 years. The median LOS was 54.6 h (Interquartile range 17.5, 149.3 h). From the multivariable analysis, four clinical characteristics were identified as independent predictors with an increase in LOS. These were patients with New York Heart Association (NYHA) functional class III/IV (+72.9 h, 95%Confidence interval (CI) 23.9, 121.8, p = 0.004), respiratory rate >24 per minute (+80.7 h, 95%CI 28.0, 133.3, p = 0.003), hemoglobin level <10 mg/dL (+60.4 h, 95%CI 8.6, 112.3, p = 0.022), and serum albumin <3.5 g/dL (+52.8 h, 95%CI 3.6, 102.0, p = 0.035). Conclusions: Poor NYHA functional class, tachypnea, anemia, and hypoalbuminemia are significant clinical predictors of patients with acute heart failure who required longer LOS.

scholarly journals Effect of Empagliflozin on the Clinical Stability of Patients with Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial

Circulation ◽  
2020 ◽  
Author(s):  
Milton Packer ◽  
Stefan D. Anker ◽  
Javed Butler ◽  
Gerasimos S. Filippatos ◽  
João Pedro Ferreira ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Functional Class ◽  
Hazard Ratio ◽  
Double Blind ◽  
Reduced Ejection Fraction ◽  
Risk Of Death ◽  
Nyha Functional Class ◽  
Patients With Heart Failure

Background: Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, with or without diabetes, but additional data are needed about the effect of the drug on inpatient and outpatient events that reflect worsening heart failure. Methods: We randomly assigned 3730 patients with class II-IV heart failure with an ejection fraction of ≤40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to recommended treatments for heart failure, for a median of 16 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite endpoints. Results: Empagliflozin reduced the combined risk of death, hospitalization for heart failure or an emergent/urgent heart failure visit requiring intravenous treatment (415 vs 519 patients; empagliflozin vs placebo, respectively; hazard ratio 0.76, 95% CI: 0.67-0.87), P <0.0001. This benefit reached statistical significance at 12 days after randomization. Empagliflozin reduced the total number of heart failure hospitalizations that required intensive care (hazard ratio 0.67, 95% CI 0.50-0.90, P=0.008) and that required a vasopressor or positive inotropic drug or mechanical or surgical intervention (hazard ratio 0.64, 95% CI: 0.47-0.87, P=0.005). As compared with placebo, fewer patients in the empagliflozin group reported intensification of diuretics (297 vs 414), hazard ratio 0.67, 95% CI: 0.56-0.78, P<0.0001. Additionally, patients assigned to empagliflozin were 20-40% more likely to experience an improvement in NYHA functional class and were 20-40% less likely to experience worsening of NYHA functional class, with statistically significant effects that were apparent 28 days after randomization and maintained during long-term follow-up. The risk of any inpatient or outpatient worsening heart failure event in the placebo group was high (48.1 per 100 patient-years of follow-up), and it was reduced by empagliflozin (hazard ratio 0.70, 95% CI: 0.63-0.78), P<0.0001. Conclusions: In patients with heart failure and a reduced ejection fraction, empagliflozin reduced the risk and total number of inpatient and outpatient worsening heart failure events, with benefits seen early after initiation of treatment and sustained for the duration of double-blind therapy. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03057977

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