scholarly journals 157 Efficacy and tolerability of sacubitril/valsartan in patients with chronic heart failure and reduced ejection fraction

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Antonio Cerciello ◽  
Norman Lamaida

Abstract Aims The PARADIGM-HF study has shown, as is well known, that the association of sacubitril/valsartan (SV) was superior in terms of efficacy compared to enalapril in patients suffering from heart failure chronic cardiac (SC) and reduced systolic function (HFrEF). We have analysed the use of SV in patients with symptomatic HF and HFrEF, andits effect on humoural and functional parameters of easy evaluation. Methods and results From March 2018 to December 2019 we have introduced the SV in 158 patients 135 M and 23 F mean age 40–80 years with fraction of ejection <35% with idiopathic dilated cardiomyopathy (six patients) or post-ischaemic (150 patients), in NYHA III class. Patients were declared eligible according to the ESC 2016 criteria (EF 40%, NT-proBNP> 400 ng/l, target dose of ACE inhibitors/receptor antagonists angiotensin, GFR> 30 ml/min/1.73 m2, serum S-potassium <5.2 mmol/l, treatment with beta-blockers and antialdosteronics). Initially the administration of SV was a cp of 49/51 mg bid up to maximum tolerated dose (one tablet of 97/103 mg bid). All the patients had stopped taking ACE-I or sartans 48 h before and were evaluated at 4-week intervals for two years. In all patients we evaluated: ejection fraction (FE), filtered glomerular, systolic blood pressure, body weight, side effects, hospitalization and mortality. Of the 156 patients, 17 achieved the optimal dose of SV (97/103 mg), 113 achieved SV 49/51 mg bid. In all patients did not experience side effects or alterations of the electrolyte picture and renal function. The SV has determined an improvement NYHA class of at least 1; the echocardiogram showed a significant increase in FE: at follow-up 89 patients reached FE 45%, 44 patients FE 40–44%, and 6 patients about 50%; besides it is an improvement in indexed end-diastolic volume in moles was noted above patients (from 118.4 ± 38.4 to 110.9 ± 30 ml/m2). No case of re-hospitalization. Conclusions Our experience shows that the use of SV is well tolerated, improves functional capacity and ventricular remodelling and that does not modify the parameters of renal function and electrolytic of the patients.

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
M V Polito ◽  
A Rispoli ◽  
V Vitulano ◽  
F D"auria ◽  
A Silverio ◽  
...  

Abstract Funding Acknowledgements none Aims. To evaluate the effects of Sacubitril/Valsartan (S/V) on clinical, laboratory and echocardiographic parameters and outcomes in a real-world population with heart failure with reduced ejection fraction (HFrEF). Methods and results. Prospective study enrolling consecutive patients with HFrEF treated with S/V.The primary outcome was HF rehospitalization;secondary outcomes were all-cause death, cardiac death and the composite of cardiac death and HF rehospitalization at 12 months follow up.The clinical outcome was compared with a retrospective cohort of 90 HFrEF patients treated with standard medical therapy by using propensity score weighting. At 6 months follow-up, changes in symptoms, echocardiographic parameters, eGFR and furosemide dose were also evaluated. The study population consisted of 90 patients (66.1 ± 11.7 years). At 6 months FU, a significant improvement in NYHA class, LVEF (from 31.0% to 34.0%; p = 0.001), LVESV (from 115.0 to 101.0 mL; p = 0.033) and sPAP (from 31.0 to 25.0 mmHg; p = 0.024) was observed. Moreover, S/V did not affect negatively eGFR and was associated with a significantly lower dose of furosemide prescribed. The propensity score weighting adjusted regression analysis showed a significantly lower risk for HF rehospitalization (HR, 0.131; 95% CI, 0.034-0.503; p = 0.003) and the composite outcome (HR, 0.162; 95% CI, 0.053-0.492; p = 0.001) among patients treated with S/V as compared to the standard therapy group. Conclusions In this real-world HFrEF population, S/V reduced HF rehospitalization and cardiac death at 1 year. Moreover, S/V improved significantly NYHA class, LVEF, LVESV and sPAP at 6 months, preserving renal function and reducing the need of furosemide. Table Study outcomes Unadjusted model HR 95% CI p-value HF rehospitalization 0.273 0.101-0.740 0.011 Cardiac death 0.443 0.137-1.440 0.176 Composite outcome 0.331 0.155-0.710 0.005 All-cause death 0.666 0.272-1.628 0.372 Adjusted model HR 95% CI p-value HF rehospitalization 0.131 0.034-0.503 0.003 Cardiac death 0.259 0.047-1.415 0.119 Composite outcome 0.162 0.053-0.492 0.001 All-cause death 0.713 0.201-2.529 0.601 Adjusted and unadjusted HR for the study outcomes. Abstract 412 Figure.


2020 ◽  
Vol 16 (2) ◽  
pp. 65-70
Author(s):  
Md Noornabi Khondokar ◽  
Khurshed Ahmed ◽  
Mohammad Ashraf Hossain ◽  
Rakibulh Rashed ◽  
Mohamed Mausool Siraj ◽  
...  

Background:Chronic heart failure (CHF) is the most common and prognostically unfavorable outcome of many diseases of the cardiovascular system. Clinical trials have demonstrated mortality and morbidity benefits of mineralocorticoid receptor antagonists (MRAs) in patients with heart failure. These studies have used either eplerenone or spironolactone as the MRA. Eplerenone is a selective aldosterone antagonist expected to have a lower incidence of hormonal side effects than spironolactone. The present study is designed to compare these two drugs in chronic heart failure patients as no head to head trial between these two drugs is found regarding improvement of systolic function, tolerability and safety. The aim of this study is to compare the effects of eplerenone and spironolactone on LV systolic function in patients with chronic heart failure in a single center. Methods:It was a randomized clinical trial single blind study. A total of 224 cases of chronic heart failure with reduced ejection fraction and NYHA class III or IV were selected by random sampling, from July 2017 to June 2018. Each patient was randomly allocated into either of the two arms, and was continued receiving treatment with either spironolactone (Arm-I) or eplerenone(Arm-II). Each patient was evaluated clinically, biochemically and echocardiographically at the beginning of treatment (baseline) at 1 month and at the end of 6th month. Echocardiography was performed to find out change in left ventricular systolic function. Result: After 6 months of treatment, ejection fraction was found higher in the eplerenonearm (40.3 ± 6.5 versus 38.3 ± 4.6%; P < 0.05). Ejection fraction (EF) changes were 6.2% in eplerenone group and 4.1% in spironolactonearm. A significant reduction in left ventricular end-systolic volume (21.9±2.5 in group I versus 14.9±5.7 in group II; P < 0.05) and left ventricular systolic diameter (48.7±4.0 in arm I versus 45.2±4.9 in arm II; P<0.05) occurred after 6 months of treatment. But no significant differences were observed in left ventricular end-diastolic volume (187.8±37.4 versus 184.5±33.9; P=0.101) and left ventricular diastolic diameter (60.1±4.5 versus 61.0±4.9; P=0.0818) between arms. Assessment of blood pressure six months after treatment shows, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were improved in both arms but difference between two arms were statistically non-significant (p>0.05). Conclusion: In this study, the improvement in systolic function was more in eplerenone arm, which also had fewer adverse side effects when compared to spironolactone arm. So, it can be concluded that eplerenone can be advised in patient with chronic heart failure in addition to other drugs that are used to treat heart failure. University Heart Journal Vol. 16, No. 2, Jul 2020; 65-70


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
S Wisniowska-Smialek ◽  
A Karabinowska ◽  
K Holcman ◽  
E Dziewiecka ◽  
A Lesniak-Sobelga ◽  
...  

Abstract Background According to the latest approach new class ARNI with sacubitryl-valsartan may be ordered in clinically stable heart failure patients with reduced ejection fraction ( HFrEF) or short time after acute heart failure exacerbation. Methods: Since July 2016 till February 2019 we started ARNI in 50 HFrEF patients; 33 (66%) were clinically stabile during at least 3 months and 17 (34%) were short time after HF exacerbation. Results: There were no differences in age (63 vs 58) and BMI between groups. Clinically stabile patients presented significantly lower NYHA class (2 ± 0,5 vs 3 ± 0,7) and lower NT-proBNP level (1948 pg/ml vs 5570 pg/ml) in comparison to those after HF decompensation. There were no differences in left ventricular end-diastolic diameter (LVEDD), volume (LVEDV) and ejection fraction (EF) between both groups. Patients after HF decompensation had greater left and right atrium area(LAA, RAA respectively), higher estimated pulmonary artery pressure (PASP) and reduced right ventricular systolic function expressed with TAPSE (tricuspid annular plane systolic excursion) in comparison to stabile patients. Patients from both groups presented similar physical activity tolerance estimated with 6-minute walking test ( 6- MWT): 369 m vs 402 m (tbl). Conclusions: Clinical, echocardiographic and laboratory differences were observed between groups of HFrEF patients with different clinical status when ARNI was administrated. Parameter Stabile n = 33 After HF decompensation n= 17 p- value BMI [kg/m2] 25(23-36) 25(21-26) 0,72 Age [years] 63 (39-68) 58 (42-67) 0,81 NYHA 2 ± 0,5 3 ± 0,7 0,001 NT-proBNP [pg/ml] 1948(601-2933) 5570(4147-8021) P&lt; 0,001 6 MWT dystans [m] 369(327-432) 402(240-480) 0,32 FW [%] 23 (18-28) 19(15-26) 0,17 LVEDD [mm] 69(59-76) 64(63-71) 0,32 LVEDvol [ml] 242(153-324) 225(178-235) 0,29 TAPSE [mm] 19(14-21) 14(13-16) 0,02 LAA [cm2] 28(24-34) 36(27-39) 0,032 RAA [cm2] 19(16-30) 26(23-32) 0,046 PASP [mmHg] 31(23-43) 43(38-55) 0,046


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Cze-Ci Chan ◽  
Kuang-Tso Lee ◽  
Wan-Jing Ho ◽  
Yi-Hsin Chan ◽  
Pao-Hsien Chu

Abstract Background Acute heart failure is a life-threatening clinical condition. Levosimendan is an effective inotropic agent used to maintain cardiac output, but its usage is limited by the lack of evidence in patients with severely abnormal renal function. Therefore, we analyzed data of patients with acute heart failure with and without abnormal renal function to examine the effects of levosimendan. Methods We performed this retrospective cohort study using data from the Chang Gung Research Database (CGRD) of Chang Gung Memorial Hospital (CGMH). Patients admitted for heart failure with LVEF ≤ 40% between January 2013 and December 2018 who received levosimendan or dobutamine in the critical cardiac care units (CCU) were identified. Patients with extracorporeal membrane oxygenation (ECMO) were excluded. Outcomes of interest were mortality at 30, 90, and 180 days after the cohort entry date. Results There were no significant differences in mortality rate at 30, 90, and 180 days after the cohort entry date between the levosimendan and dobutamine groups, or between subgroups of patients with an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 and eGFR < 30 mL/min/1.73 m2 or on dialysis. The results were consistent before and after propensity score matching. Conclusions Levosimendan did not increase short- or long-term mortality rates in critical patients with acute heart failure and reduced ejection fraction compared to dobutamine, regardless of their renal function. An eGFR less than 30 mL/min/1.73 m2 was not necessarily considered a contraindication for levosimendan in these patients.


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


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Ayesha Azmeen ◽  
Naga Vaishnavi Gadela ◽  
Vergara Cunegundo

Introduction: Heart failure(HF) is a clinical syndrome that is widely prevalent affecting approximately 6.5 million people in the United States. It accounts for the ever-rising health care costs in the US due to recurrent hospitalizations. Despite advancements in medical management, the mortality and the rate of hospitalizations continues to be high with geographic variations and racial disparities. Through this descriptive study, we sought to analyze the health disparities among Hispanic, African American (AA) and Caucasian population in a single-center. Methods: We identified a total of 178 patients with HF with reduced ejection fraction from our outpatient clinic by utilizing the ICD-10 codes. Patients with ejection fraction >50% have been excluded. A retrospective chart review of their ethnic background, medications, and number of heart failure exacerbations per year has been performed. Results: 178 patients (mean age 62 years, 35.56% of females) including Hispanics (n=102), AA(n=44), and Caucasians (n=32) were included in the study. Although all patients were started on Beta-blockers, only 76.4% and 37.2% of Hispanics were started on ACEi/ARBs and spironolactone respectively. Similarly, 72.7% and 45.4% of AA were started on ACEi/ARBs and spironolactone respectively. This is in contrast to Caucasians population, where a majority of patients were on started on GDMT; 90% and 75% were started on ACEi/ARBs and spironolactone respectively. This was also reflected by the number of admissions due to HF exacerbations which ranged from 2-4/year for Hispanics and AA populations and 0-1/year for Caucasians. Conclusions: GDMT for HF is known to reduce heart failure exacerbations, mortality and the ever rising cost of the healthcare system. We have observed that despite recommendations to initiate GDMT in all patients with HF with reduced ejection fraction, racial disparities exist. Physicians should be mindful of initiating GDMT in all patients.


2017 ◽  
Vol 2017 ◽  
pp. 1-17 ◽  
Author(s):  
Andreas B. Gevaert ◽  
Katrien Lemmens ◽  
Christiaan J. Vrints ◽  
Emeline M. Van Craenenbroeck

Although the burden of heart failure with preserved ejection fraction (HFpEF) is increasing, there is no therapy available that improves prognosis. Clinical trials using beta blockers and angiotensin converting enzyme inhibitors, cardiac-targeting drugs that reduce mortality in heart failure with reduced ejection fraction (HFrEF), have had disappointing results in HFpEF patients. A new “whole-systems” approach has been proposed for designing future HFpEF therapies, moving focus from the cardiomyocyte to the endothelium. Indeed, dysfunction of endothelial cells throughout the entire cardiovascular system is suggested as a central mechanism in HFpEF pathophysiology. The objective of this review is to provide an overview of current knowledge regarding endothelial dysfunction in HFpEF. We discuss the molecular and cellular mechanisms leading to endothelial dysfunction and the extent, presence, and prognostic importance of clinical endothelial dysfunction in different vascular beds. We also consider implications towards exercise training, a promising therapy targeting system-wide endothelial dysfunction in HFpEF.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
G Cinier ◽  
MI Hayiroglu ◽  
L Pay ◽  
AC Yumurtas ◽  
O Tezen ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable cardiac defibrillators (ICD) are recommended in heart failure with reduced ejection fraction (HFrEF) patients to reduce arrhythmic deaths. The only contraindication for not implanting ICD is life expectancy of less than 1 year. We aimed to identify risk factors associated with mortality within 1 year following the device implantation. Methods Data from our hospital’s electronic database system was extracted for patients who were implanted ICD secondary to HFrEF between 2009 and 2019. Those who died within 1 year following the device implantation were analyzed in the present paper. Multiple Cox regression analysis using the backward logistical regression method was applied to determine the best predictors that affect 1-year mortality Results Overall 1107 patients were included in the present analysis. ICD was implanted in 77.2% and 22.8% for ischemic and non-ischemic HFrEF respectively. Mortality rate at 1-year following the device implantation was 4.7%. In multivariate analysis age [Hazard ratio (HR), 1.04; Confidence 95% Intervals (CI), 1.02 – 1.06; P = 0.001], atrial fibrillation (AF) (HR, 4.12; 95% CI, 2.34 – 7.24, P &lt; 0.001), NYHA class &gt; 2 symptoms (HR, 5.33; 95% CI, 2.92 – 9.73, P &lt; 0.001), blood urea nitrogen (BUN) (HR, 1.02; 95% CI, 1.00 – 1.03, P = 0.03) and albumin (HR, 0.52; 95% CI, 0.34 – 0.80, P = 0.003) independently predicted 1-year mortality Conclusion In patients with HFrEF and implanted ICD, older age, presence of AF and NYHA class &gt; II symptoms, elevated BUN and reduced albumin levels predicted 1-year mortality. Table 1 Multivariate analysis P value HR (95% CI) Age 0.001 1.038 (1.015 - 1.062) Atrial fibrillation &lt;0.001 4.119 (2.342 - 7.241) NYHA &gt; 2 &lt;0.001 5.328 (2.917 - 9.731) Blood urea nitrogen 0.034 1.017 (1.001- 1.034) Albumin 0.003 0.520 (0.337 - 0.801) Multivariate Cox regression analyses for 1-year mortality after implantation


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