Treatment with sacubitril/valsartan in European outpatients with chronic heart failure in Europe: results from ARIADNE registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Maggioni ◽  
V Barrios ◽  
A.L Clark ◽  
T Damy ◽  
J Drozdz ◽  
...  

Abstract Background Recently, the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan (S/V) was introduced as a novel therapeutic option into European guidelines for the management of heart failure (HF). The Assessment of Real lIfe cAre –Describing EuropeaN hEart failure management (ARIADNE) registry provides real world information about its use and efficacy in real life in outpatients with heart failure with reduced ejection fraction (HFrEF) in Europe. Methods ARIADNE was a prospective registry of patients with HFrEF (NYHA II-IV, reduced EF) treated by office-based cardiologists or selected primary care physicians (recognized as HF specialists) in a real world setting. 9069 HFrEF patients were enrolled from 674 investigators in 17 European countries, and followed over 12 months. Out of 8787 patients fulfilling criteria for analysis, 52.5% of the patients received S/V treatment at baseline, whereas 47.5% continued on their previous individualized heart failure medication. Results of S/V patients are reported here. Results The mean age of patients prescribed S/V was 67.3 years, mainly NYHA class II or III (49.7% and 48.2%, respectively), and mean LVEF of 32.7%. Common documented comorbidities were arterial hypertension (63.7%), coronary heart disease (62.4%), dyslipidemia (50.3%), diabetes (32.5%), and chronic kidney disease (24.1%). Of the 4143 patients in the S/V group, 89.9% received S/V at baseline, 74.8% received S/V in combination with a β-blocker; 47.8% with a β-blocker and MRA. Within 6 months of the observational period, 693 (17.4%) of the S/V patients were hospitalized, of which 46.8% and 28.7%, had HF related and non-HF cardiovascular (CV) hospitalizations. Emergency room visits without hospitalization were documented for 3.4% of S/V patients in the same time period; stroke and myocardial infarction occurred in 22 (0.5%) and 24 (0.6%) of the S/V patients, respectively. Cardiac catheterization or coronary angiography procedures were applied to 1.7% and 2.8% of the S/V patients. Total mortality was 4.3% (S/V 3.8%; non-S/V 5.0%), cardiovascular mortality 1.9% (S/V 1.8%; non-S/V 2.2%), during the 12 month observational period. The proportion of S/V patients in NYHA class III or IV decreased in the course of the study from 44.6% to 24.0%. After 12 months of follow up, 46.3% of patients with NYHA class III had a reported improvement to NYHA class II. Consistently, mean LVEF increased to 37.9%. The percentage of S/V patients with LVEF <22.5% decreased from 11.5% to 5.8%. KCCQ overall summary score increased by 1.9 points. An improvement of ≥5 points, denoting a clinically meaningful increase, was reported for 36.2% of S/V patients. Conclusions Data from the ARIADNE prospective registry portray a diverse, multinational study cohort receiving sacubitril/valsartan under real-world conditions. Throughout the study, symptoms and quality of life improved with the use of S/V. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis AG, Switzerland

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
U Zeymer ◽  
L.H Lund ◽  
V Barrios ◽  
C Fonseca ◽  
A.L Clark ◽  
...  

Abstract Background Heart failure (HF) is a major medical and economic burden that is often managed in office based practices. Recently, the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan (S/V) was introduced as novel therapeutic option into European guidelines for the management of HF. The ARIADNE registry aims to provide information on how outpatients with HF with reduced ejection fraction (HFrEF) are managed in Europe, in light of this novel treatment option. Methods ARIADNE was a prospective registry of patients with HFrEF treated by office-based cardiologists (OBC) or selected primary care physicians (recognized as HF specialists; PCP) in a real world setting. HFrEF patients were included prospectively, independently of whether treatment had been changed recently or not. 9069 patients were recruited from 687 centres in 17 European countries. Results The mean age of all patients was 68.1 years (S/V: 67.3 years, Non-S/V: 68.9 years). The majority of patients were in NYHA class II (61.3%), or NYHA class III (37.1%) overall, while more patients in the S/V group showed NYHA class III (S/V: 42.8%, Non-S/V: 30.9%). Mean LVEF was slightly lower in the S/V group than in the Non-S/V group (S/V: 32.7%, Non-S/V: 35.4%, overall 34.0%). The most frequently observed signs of HF were dyspnoea upon effort, followed by fatigue, palpitations on exertion at baseline. More patients tend to have more severe symptoms in the S/V groups (e.g. for dyspnoea on effort, Non-S/V: moderate 40.8%, severe 8.6%; S/V: moderate 46.4%, severe 14.1%). 44.0% of patients from the S/V group and 39.3% of non-S/V patients reported at least one hospitalization within 12 months prior to baseline, of which 73.3% in S/V and 69.9% in non-S/V patients were due to HF., At baseline, 44.7% of the patients used a CV device, of which most were implantable cardioverter defibrillator (ICD: Non-S/V 54.2%, S/V: 52.8%), implantable cardioverter defibrillator (CRT-ICD:Non-S/V 21.9%, S/V: 27.0%), and pacemaker (Non-S/V: 13.4%, S/V: 10.5%). The mean KCCQ overall summary score was 62.6 in the S/V group and 69.5 in the Non-S/V group at baseline. 83.9% of patients were treated with ARB or ACEi in Non-S/V group, (ACEi 57.3%, ARB 26.9%). The most frequently taken drug combinations in either group were ACEi/ ARB or S/V with β -blockers (Non-S/V 69.3%, S/V 67.3%). 40.2% in the Non-S/V group and 42.9% in S/V groups used a combination of ACEi/ARB or S/V, β-blocker and MRA. Conclusions The ARIADNE prospective registry provides insights and reflects variations in HF treatment practices in outpatients in Europe and the way S/V was introduced by OBCs and specialized PCPs in a real-world setting. In the observed population, S/V is more often prescribed to slightly younger patients with slightly lower LVEF, there was a greater observed percentage of S/V patients NYHA class III, with lower quality of life measurements and with more severe symptoms and recent hospitalizations for heart failure. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L.H Lund ◽  
U Zeymer ◽  
A.L Clark ◽  
V Barrios ◽  
T Damy ◽  
...  

Abstract Background In Europe, heart failure (HF) is managed in variable settings and frequently in office-based practice. In HF with reduced ejection fraction (HFrEF) there is now extensive evidence based therapy, but implementation is inconsistent, variable and overall inadequate. The Assessment of Real lIfe cAre –Describing EuropeaN hEart failure management (ARIADNE) registry aimed to assess in detail how outpatients with HFrEF are managed in Europe in contemporary practice. Methods ARIADNE was a prospective non-interventional registry of patients with HFrEF (NYHA class II-IV) treated by office-based cardiologists or selected primary care physicians (recognized as HF specialists) in a real world setting. Patients were enrolled in 687 centres in 17 European countries, and studied at baseline and after 6 and 12 months. Key pre-specified outcomes were deaths, hospitalizations, emergency department visits, and office visits, and their primary reasons. Results Over 20 months, we enrolled 9069 patients; median age 69 (19–96) years, 24% women, with 30% older than 75 years, 61% NYHA class II, with a median EF 35% (30–40%). Over a median follow-up of 353 (1–631) days, 382 patients (4.3%) died, with 171 cardiovascular deaths (1.9%). The rates of total hospitalizations overall, for HF, and for non-HF cardiovascular reasons were 19.3, 8.1, and 4.8 per 100 patient years, respectively; and rates of emergency department visits overall, for HF reasons, and for non-HF CV reason were 7.7, 1.6, and 1.8, respectively. The number of HF office visits were on average 1.0 per patient. Conclusions In this large multinational HFrEF registry with detailed data on cause-specific outcomes and health care utilization, incidence of death was low and outpatient HF visits were few, but incidence of HF and CV hospitalization and emergency department visits was high. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis AG, Switzerland


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Calero ◽  
E Hidalgo ◽  
R Marin ◽  
L Rosenfeld ◽  
I Fernandez ◽  
...  

Abstract Background Self-care is a crucial factor in the education of patients with heart failure (HF) and directly impacts in the progression of the disease. However, little is published about its major clinical implications as admission or mortality in patients with HF. Aims and methods The aim of the study was to analyze time to admission due to acute heart failure and mortality associated with poor self-care in patients with chronic HF. We prospectively recruited consecutive patients with stable chronic HF referred to a nurse-led HF programme. Selfcare was evaluated at baseline with the 9 item European Heart Failure Self-Care Behavior Scale. Scores were standardized and reversed from 0 (worst selfcare) to 100 (better self care). For the purpose of this study we analyzed the associations of worse self-care (defined as scores below the lower tertile of the scale) with demographic, disease-related (clinical) and psychosocial factors in all patients at baseline. Results We included 1123 patients, mean age 72±11, 639 (60%) were male, mean LVEF 45±17 and 454 (40,4%) were in NYHA class III or IV. Mean score of the 9-item ESCBE was 69±28. Score below 55 (lower tertile) defined impaired selfcare behaviour. Those patients with worse self-care had more ischaemic heart disease, more COPD, and they achieved less distance in the 6 minute walking test. Regarding psychosocial items patients in lower tertile of self-care needed a caregiver more frequently, they present more cognitive impairment, depressive symptoms and worse score in terms of health self-perception. Multivariate Cox Models showed that a score below 55 points in 9-item ESCBE was independently associated with higher readmission due to acute heart failure [HR 1.26 (1.02–1.57), p value=0.034] and with mortality [HR 1.24 CI95% (1.02–1.50), p value=0.028] Conclusion Poor self-care measured with the modified 9-item ESCBE was associated with higher risk of admission due to acute decompensation and higher risk of mortality in patients with chronic heart failure. These results highlight the importance of assessing self-care and provide measures to improve them. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Hospital Univesitario de Bellvitge


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Rapezzi ◽  
A.V Kristen ◽  
B Gundapaneni ◽  
M.B Sultan ◽  
M Hanna

Abstract Background In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis was shown to be an effective treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Further assessment of the efficacy of tafamidis in patients with more advanced ATTR-CM would aid treatment decisions. Purpose To characterize the benefits of tafamidis in patients with advanced ATTR-CM. Methods In ATTR-ACT, ATTR-CM patients were randomized to tafamidis (n=264) or placebo (n=177) for 30 months. Efficacy outcomes included all-cause mortality and frequency of cardiovascular (CV)-related hospitalisations. Key secondary endpoints were change from baseline to Month 30 in 6MWT distance and KCCQ-OS score. Efficacy assessments in NYHA Class III patients at baseline (n=141) were a pre-specified analysis. In a post-hoc analysis, mortality and CV-related hospitalizations were assessed in all patients grouped into quartiles of increasing disease severity based on 6MWT distance at baseline. Longer-term all-cause mortality (as of 1 Aug 2019) was assessed in NYHA Class III patients utilizing data from ATTR-ACT patients who enrolled in a long-term, extension study (LTE) and continued treatment with higher dose tafamidis (n=55; median treatment duration 51.6 months); or, if previously treated with placebo, started tafamidis treatment (placebo/tafamidis; n=63 [50.1 months]). Results In advanced ATTR-CM patients (NYHA Class III), tafamidis reduced the risk of death (HR [95% CI] 0.837, [0.541, 1.295], P=0.4253), and the decline in 6MWT distance (LS mean [SE], 31.6 (22.1) m; P=0.1526) and KCCQ-OS score (LS mean [SE], 13.1 (5.0); P=0.0090), vs placebo. Paradoxically, there was a higher frequency of CV-related hospitalizations with tafamidis (RR [95% CI] vs placebo, 1.411 [1.048, 1.900]). In all patients by 6MWT quartile, CV-related hospitalizations/year with tafamidis and placebo increased with disease severity, with the exception that placebo-treated patients in the highest severity quartile had fewer CV-related hospitalisations (0.73) than those in the third quartile (0.92). Mortality with tafamidis and placebo increased, and was greater with placebo, in every quartile (Figure). Survival (NYHA Class III patients in ATTR-ACT and LTE) was improved with high dose tafamidis with longer term follow-up (HR vs placebo/tafamidis [95% CI], 0.6569 [0.4175, 1.0336]; P=0.0692). Conclusions These analyses, including longer-term follow-up, demonstrate that patients with advanced ATTR-CM benefit from tafamidis. The decrease in CV-related hospitalisations in more severe patients treated with placebo suggests that the comparatively greater hospitalisation frequency in NYHA Class III patients treated with tafamidis is a consequence of their lower mortality rate. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was sponsored by Pfizer


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Lahoz ◽  
S Corda ◽  
C Proudfoot ◽  
A.F Fonseca ◽  
S Cotton ◽  
...  

Abstract Background and purpose The majority of patients with heart failure (HF) have difficulties in independently carrying out activities of daily living and hence, require support from caregivers (CGs). This study assessed the quality of life (QoL) of CGs of HF patients with sub-normal LVEF (≤60%). Methods A cross-sectional survey of HF patients and their CGs was conducted in France, Germany, Italy, Spain and the UK. Cardiologists and primary care physicians completed patient record forms (PRF) between June and November 2019. Caregivers of the same patients were invited to complete a caregiver self-completion survey, which included the Family Caregiver QoL Scale (FAMQOL) and EQ-5D. Patient demographics were derived from PRFs. Results 361 CGs (73.1% female, mean age: 58.8 yrs) and HF patients (39.9% female, mean age: 71.2 yrs) were included. 58.2% of the CGs were spouses, 23.4% a child of the patient. On average, CGs devoted 20 hrs/week in the care of HF patients; this CG time increased from 12 to 26 hrs/week with NYHA class I to III/IV of the HF patient. Further, anxiety/stress was experienced overall by 29/31% of CGs which increased from 27/17% for NYHA I to 40/41% for NYHA III/IV of the HF patient (Table 1). Conclusions Caregivers of patients with HF and LVEF ≤60% spend a significant amount of time to provide daily support to HF patients. Patients with progressive disease were older, more polymorbid and had a higher disease duration. These factors likely contributed towards increased caregiver burden of HF patients with increased NYHA class. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG


2019 ◽  
Vol 15 (2) ◽  
pp. 47-53
Author(s):  
Ashaduzzaman Talukder ◽  
Mohamed Mausool Siraj ◽  
Md Noornabi Khondokar ◽  
SM Ahsan Habib ◽  
Md Abu Salim ◽  
...  

Background: Heart Failure (HF) is a major public health burden worldwide. Approximately 5 million Americans, 0.4–2% of the general European population and over 23 million people worldwide are living with heart failure. Like few other chronic disease, low serum albumin is common in patients with heart failure (HF). However, very few studies evaluated the outcome of albumin infusion in different stages of HF. Therefore, the objective of this study is to assess the outcome of albumin infusion in heart failure patients. Methods: It was a cross-sectional study. A total of 50 cases of chronic heart failure with reduced ejection fraction and NYHA class III or IV with serum albumin level <2.5g/dl who were admitted in CCUwere selected by purposive sampling, from September 2017 to August 2018. 100ml of 20% albumin was infused and serum albumin was measured after 3 days. Then the patients were divided into two groups, Patients who failed to attain serum albumin of 3g/dl(Group A) or Patients who attained serum albumin of ≥3g/dl (Group B). Analysis and comparison for symptomatic improvement of heart failure by NHYA classification and LVEF was done at 10th day after infusion between group A and B. Result: Among the 50 patients, mean age of patients was 53.64 ± 13.44 years (age range: 26-84 years) with a male-female ratio of 3:2 (60%-male vs 40%- female). Majority patients were previously re-admitted at least two times (40%), 28% were re-admitted once, 16% were re-admitted three times and 4% were re-admitted for four times. Of all, 56% patients presented NYHA class IV and AHA stage D heart failure (56%) and 44% patients presented with NYHA class III and AHA stage C. At day 10 follow up following albumin infusion, overall frequency of following ten days of albumin therapy, in group B, 8 patients (72.7%) among Class III improved to Class I and 3 patients (27.3%) improved to class II. Also, 7 patients (50%), 5 patients (35.7%) and 2 patients (14.3%) among class IV improved to respectively class I, class II and class III. In group A, 3 patients (27.3%) among class III improve to class II and 8 patients (72.7%) remain in class III. Also, 2 patients (14.3%), 5 Patients (35.7%) and 7 patients (50%) among class IV improve to respectively class I, class II and class III. Moreover, statistically significant improvement was noted in ejection fraction of patents irrespective of initial class of heart failure (p<0.001) in group B patients compare to group A (p<0.09). Conclusion: In this study, the improvement of heart failure was more in patients who attained albumin level of ≥3g/dl.Therefore, in can be concluded that albumin infusion improves both subjective and objective improvement of patients with heart failure. University Heart Journal Vol. 15, No. 2, Jul 2019; 47-53


2020 ◽  
Author(s):  
Xinchan Jiang ◽  
Jiaqi Yao ◽  
Joyce HS You

BACKGROUND Telemonitoring-guided interventional management reduces the need for hospitalization and mortality of patients with chronic heart failure (CHF). OBJECTIVE This study aimed to analyze the cost-effectiveness of usual care with and without telemonitoring-guided management in patients with CHF discharged from the hospital, from the perspective of US health care providers. METHODS A lifelong Markov model was designed to estimate outcomes of (1) usual care alone for all postdischarge patients with CHF (New York Heart Association [NYHA] class I-IV), (2) usual care and telemonitoring for all postdischarge patients with CHF, (3) usual care for all postdischarge patients with CHF and telemonitoring for patients with NYHA class III to IV, and (4) usual care for all postdischarge patients with CHF plus telemonitoring for patients with NYHA class II to IV. Model inputs were derived from the literature and public data. Sensitivity analyses were conducted to assess the robustness of model. The primary outcomes were total direct medical cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). RESULTS In the base case analysis, universal telemonitoring group gained the highest QALYs (6.2967 QALYs), followed by the telemonitoring for NYHA class II to IV group (6.2960 QALYs), the telemonitoring for NYHA class III to IV group (6.2450 QALYs), and the universal usual care group (6.1530 QALYs). ICERs of the telemonitoring for NYHA class III to IV group (US $35,393 per QALY) and the telemonitoring for NYHA class II to IV group (US $38,261 per QALY) were lower than the ICER of the universal telemonitoring group (US $100,458 per QALY). One-way sensitivity analysis identified five critical parameters: odds ratio of hospitalization for telemonitoring versus usual care, hazard ratio of all-cause mortality for telemonitoring versus usual care, CHF hospitalization cost and monthly outpatient costs for NYHA class I, and CHF hospitalization cost for NYHA class II. In probabilistic sensitivity analysis, probabilities of the universal telemonitoring, telemonitoring for NYHA class II to IV, telemonitoring for NYHA class III to IV, and universal usual care groups to be accepted as cost-effective at US $50,000 per QALY were 2.76%, 76.31%, 18.6%, and 2.33%, respectively. CONCLUSIONS Usual care for all discharged patients with CHF plus telemonitoring-guided management for NYHA class II to IV patients appears to be the preferred cost-effective strategy.


2020 ◽  
Vol 19 (5) ◽  
pp. 2404
Author(s):  
V. N. Larina ◽  
V. I. Lunev ◽  
M. N. Alekhin

Left ventricular (LV) global function index (LVGFI) is a novel marker that incorporates the functional and structural characteristics of the LV.Aim. To evaluate the prognostic value of LVGFI in outpatients with heart failure with preserved ejection fraction (HFpEF) aged 60 years and older.Material and methods. The study included 78 patients (male, 42%) aged 74 (67-77) years with NYHA class II-III heart failure. LVGFI was defined as LV stroke volume/LV global volume х 100, where LV global volume was the sum of the LV mean cavity volume ((LV end-diastolic volume + LV end-systolic volume)/2) and myocardial volume (LV mass/ density).Results. The median LVGFI was 21,7% (interquartile range 19,3 to 22,9%). Higher NYHA class of HF was associated with worse LVGFI:class II HF was associated with LVGFI of 22,0 (20,3-23,1)%, class III HF — with 20,4 (17,5-22,4)%. During the 3—month (24-48) follow-up period, 15 (19,2%) patients died. Among patients with NYHA class II HF, 6 out of 61 (9,8%) died, with class III HF — 9 out of 17 (53,0%) (p<0,001). According to ROC analysis, the optimal LVGFI cut-off point for the prediction of an unfavorable prognosis in patients with HFpEF aged 60 years was ≤21,1% (p<0,001). The sensitivity was 73,3%, specificity — 70,0%. Patients with LVGFI ≤21,1% had significantly lower survival: among patients with LVGFI ≤21,1%, 11 out of 30 (36,7%) died; among those with LVGFI >21,1%, 4 out of 48 (8,3 %) died (p=0,016).Conclusion. Higher NYHA class of HF was associated with worse LVGFI. Patients with lower LVGFI have significantly lower survival. The optimal LVGFI cut-off point for the prediction of an unfavorable prognosis in patients with HFrEF aged 60 years was <21,1%.


2014 ◽  
Vol 27 (3) ◽  
pp. 159-164 ◽  
Author(s):  
Elzbieta Kimak ◽  
Grzegorz Dzida ◽  
Dariusz Duma ◽  
Andrzej Prystupa ◽  
Magdalena Halabis ◽  
...  

ABSTRACT The aim of the study was to examine concentrations and relationships between melatonin levels assessed at 0:200 hrs and 0:700 hrs, lipid hydroperoxide (LPO) assessed at 0:200 hrs and 0:700 hrs, and apolipoprotein (apo)AI, apoAII, apoB, high sensitivity C-reactive protein (hsCRP) and NT-proBNP, in 27 patients with chronic heart failure (CHF) (17 patients - with NYHA class II and 10 - with NYHA class III). In the study, Lipoproteins apoAI, apoAII, apoB, high sensitivity C-reactive protein (hsCRP) levels were determined by way of immunonephelometric methods, serum melatonin concentration was measured by using a competitive enzyme immunoassay technique, while serum LPO concentration was measured by using Cayman’s Lipid Hydroperoxide Assay Kit. In the study, CHF patients without acute inflammatory response demonstrated a decreased concentration of high density lipoprotein cholesterol (HDL-C), apoAI, apoAII levels, but an increased concentration of NT-proBNP, hsCRP and LPO at night, and LPO at daytime; however, the concentration of LPO at 0:700 was lower than at 0:200. Pearson’s correlation test and multiple ridge stepwise regression showed that melatonin administered at night exerts an effect on the composition of apoAI and apoAII of HDL particles, and induces decreased LPO at 0:700, but has no effect upon NT-proBNP levels in patients with NYHA class II. However, in patients with NYHA class III, melatonin administered at night induces an increase in the content of apoAII and apoAI, which further decreases hsCRP, and this, together with the administered melatonin, brings about daytime decreases in NT-proBNP and hsCRP levels. The results indicated that the content of apoAII and apoAI in HDL particles and melatonin demonstrate an anti-oxidative and anti-inflammatory effect, and together, have a cardio-protective effect on patients with advanced CHF. Hence, the results support melatonin being a cardio-protective agent. These relationships, however, need to be confirmed in further studies.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
U Zeymer ◽  
L.H Lund ◽  
V Barrios ◽  
C Fonseca ◽  
A.L Clark ◽  
...  

Abstract Background Recently, the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan was introduced as novel therapeutic option into European guidelines for the management of heart failure. The ARIADNE registry provides information about its safety and tolerability profile in real life in outpatients with heart failure with reduced ejection fraction (HFrEF) in Europe. Methods ARIADNE was a prospective registry of patients with HFrEF treated by office-based cardiologists or selected primary care physicians (recognized as HF specialists) in a real world setting. In total, 9069 HFrEF patients in 687 centres from 17 European countries were included and prospectively followed over 12 months. Here we report the safety information from 4614 patients that received sacubitril/valsartan at baseline. Results The mean age of patients was 67.3 years at baseline. The majority of enrolled patients were in NYHA class II or III (49.7% and 48.2%, respectively). Mean LVEF was 32.7% in the S/V group. Patients with S/V had arterial hypertension (62.5%), coronary heart disease (61.0%), dyslipidemia (50.6%), atrial fibrillation (41.0%), diabetes (34.3%), and chronic kidney disease (26.0%). Co-medications were beta-blockers (83.4%), MRAs (60.1%), loop diuretics (65.2%), and digitalis (7.5%). S/V was discontinued due to an adverse event (AE) during the 12 months in 191 (4.1%) patients, of these in 180 (3.6%) due to AEs and 28 (0.6%) due to SAEs. The most frequent AE was hypotension, which was reported in 391 (7.9%) of patients, of these 74 (18.9%) discontinued S/V. Hypokalaemia was observed in 1.7% and an impairment of renal function in 1.0% of S/V patients, respectively. Total mortality was 3.8%, cardiovascular mortality 1.8% in the S/V group. Conclusions This is the first large prospective study on the use of S/V in patients with HFrEF in Europe. S/V was well tolerated with a safety profile comparable with that observed in clinical trials for S/V patients. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis Pharma AG


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