scholarly journals Characterizing a Clinical Trial – Representative, Real-World Population with Heart Failure with Reduced Ejection Fraction

2022 ◽  
Vol Volume 14 ◽  
pp. 39-49
Author(s):  
Quinn S Wells ◽  
Eric Farber-Eger ◽  
Loren Lipworth ◽  
Paul Dluzniewski ◽  
Ricardo Dent ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Ejection Fraction ◽  
Real World ◽  
World Population ◽  
Reduced Ejection Fraction

Characteristics and Outcomes of a Real-world Population with Heart Failure with Reduced Ejection Fraction Representative of Clinical Trial Patients

2020 ◽  
Vol 26 (10) ◽  
pp. S82
Author(s):  
Sarah S. Cohen ◽  
Eric Farber-Eger ◽  
Loren Lipworth ◽  
John Umejiego ◽  
Ricardo Dent ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Ejection Fraction ◽  
Real World ◽  
World Population ◽  
Reduced Ejection Fraction

scholarly journals Real-world treatment switching to sacubitril/valsartan in patients with heart failure with reduced ejection fraction: A cohort study

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001305
Author(s):  
Sashiananthan Ganesananthan ◽  
Nisar Shah ◽  
Parin Shah ◽  
Hossam Elsayed ◽  
Julie Phillips ◽  
...  
Keyword(s):  
Heart Failure ◽  
Blood Pressure ◽  
Clinical Trial ◽  
Ejection Fraction ◽  
Real World ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Reduced Ejection Fraction ◽  
Treatment Switching

BackgroundSacubitril/valsartan is an effective treatment for heart failure with reduced ejection fraction (HFrEF) based on clinical trial data. However, little is known about its use or impact in real-world practice. The aim of this study was to describe our routine clinical experience of switching otherwise optimally treated patients with HFrEF to sacubitril/valsartan with respect to patient outcomes such as quality of life (QoL) and echocardiographic variables.Methods and resultsFrom June 2017 to May 2019, 80 consecutive stable patients with HFrEF on established and maximally tolerated guideline-directed HF therapies were initiated on sacubitril/valsartan with bimonthly uptitration. Clinical assessment, biochemistry, echocardiography and QoL were compared pretreatment and post-treatment switching. We were able to successfully switch 89% of patients from renin–angiotensin axis inhibitors to sacubitril/valsartan (71 of 80 patients). After 3 months of switch therapy, we observed clinically significant and incremental improvements in blood pressure (systolic blood pressure 123 vs 112 mm Hg, p<0.001; diastolic blood pressure 72 vs 68 mm Hg, p=0.004), New York Heart Association functional classification score (2.3 vs 1.9, p<0.001), Minnesota Living with Heart Failure Questionnaire score (46 vs 38, p=0.016), left ventricular ejection fraction (26% vs 33%, p<0.001) and left ventricular end systolic diameter (5.2 vs 4.9 cm, p=0.013) compared with baseline. There were no significant changes in renal function or serum potassium.ConclusionThis study provides real-world clinical practice data demonstrating incremental improvements in functional and echocardiographic outcomes in optimally treated patients with HFrEF switched to sacubitril/valsartan. The data provide evidence beyond that observed in clinical trial settings of the potential benefits of sacubitril/valsartan when used as part of a multidisciplinary heart failure programme.

Sacubitril/valsartan use in a real-world population of patients with heart failure and reduced ejection fraction

2020 ◽  
Vol 21 (11) ◽  
pp. 882-888
Author(s):  
Massimo Mapelli ◽  
Elisabetta Salvioni ◽  
Fabiana de Martino ◽  
Irene Mattavelli ◽  
Alice Bonomi ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Real World ◽  
World Population ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure

scholarly journals 257 Sodium-glucose CO-transporter-2 inhibitors eligibility in patients with heart failure with reduced ejection fraction

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Ilaria Ferrari ◽  
Francesco Cicogna ◽  
Claudia Tota ◽  
Leonardo Calò ◽  
Luca Monzo
Keyword(s):  
Heart Failure ◽  
Clinical Practice ◽  
Ejection Fraction ◽  
Real World ◽  
Sglt2 Inhibitors ◽  
Diabetic Patients ◽  
World Population ◽  
Limited Data ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure

Abstract Aims The sodium–glucose co-transporter-2 (SGLT2) inhibitors dapagliflozin and empagliflozin have been demonstrated to reduce adverse cardiovascular outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Limited data are available characterizing the generalizability of SGLT2 inhibitors treatment in the clinical practice. The aim of the study was to evaluate the proportion of outpatients with HFrEF that would be eligible for SGLT2 inhibitors in a contemporary real-world population. Methods and results We retrospectively evaluated patients with chronic stable HFrEF followed-up at the HF outpatient clinic of our institution. Patients’ eligibility was assessed according to the entry criteria of DAPA-HF (dapagliflozin) and EMPEROR-Reduced (empagliflozin) trials and to US Food and Drug Administration (FDA) label criteria (only dapagliflozin). A total of 441 HFrEF patients was enrolled. According to the major inclusion and exclusion criteria from DAPA-HF and EMPEROR-Reduced trials, 198 (45%) patients would be candidates for initiation of both dapagliflozin and empagliflozin, 61 (14%) would be eligible only to dapagliflozin and 23 (5%) only to empagliflozin, without significant differences between diabetic and non-diabetic patients (P = 0.23). Among patients not suitable for gliflozins treatment (159 patients; 36%), the major determinant of ineligibility was the failure to achieve the predefined NT-proBNP inclusion threshold. Excluding NTproBNP as per FDA label criteria, dapagliflozin eligibility increased to 86%. Conclusions In our real-world analysis a large proportion of HFrEF patients would be candidates for initiation of SGLT2 inhibitors, supporting its broad generalizability in clinical practice. This would be expected to reduce morbidity and mortality in eligible patients.

scholarly journals Validation of a novel framework defining the acceptable standard of care for heart failure with reduced ejection fraction

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Lopes ◽  
F Albuquerque ◽  
P Freitas ◽  
J Presume ◽  
B Rocha ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Medical Therapy ◽  
Real World ◽  
Standard Of Care ◽  
Left Ventricular Ejection ◽  
World Population ◽  
Reduced Ejection Fraction ◽  
Acceptable Standard ◽  
All Cause Mortality

Abstract Background In heart failure with reduced ejection fraction (HFrEF), uptitration of neurohormonal antagonists to trial-proven doses shown to reduce mortality is challenging and seldomly achieved in clinical practice. A major reason for underdosing of these agents is the lack of a clear description of what constitutes an acceptable standard of care in HFrEF. To address this limitation, a novel framework for describing the physician adherence to evidence-based treatment was recently proposed. The aim of our study was to evaluate and validate the proposed framework in a real-world population of patients with HFrEF. Methods A cohort of patients with HFrEF, defined as left ventricular ejection fraction (LVEF) &lt;40%, under treatment with neurohormonal antagonists for at least 3 months were retrospectively identified at a tertiary hospital's Heart Failure Clinic. Demographic, clinical, echocardiographic and treatment data were assessed. Patients were divided in three strata for each neurohormonal antagonist, according to the proposed framework: Status I – patients receiving target doses or the highest tolerated dose; Status II – use of subtarget doses for reasons unrelated to clinically important intolerance; and Status III – not receiving the drug at any dose. The prognostic value of each strata was assessed for all-cause mortality. Results A total of 408 patients (mean age 68±12 years, 78% male, 63% ischemic etiology) were included. The median LVEF was 31% (IQR 25–36) and most patients were in NYHA class II or III [210 (51.5%) and 163 (40%), respectively]. Medical therapy is described in Table 1. During a median follow-up of 3.3 years (IQR 1.4–5.6), 210 patients died. On univariable analysis, achieving Status I of beta-blocker (BB) therapy (HR: 0.50; 95% CI: 0.32–0.81; P=0.004) or ACEi/ARB (HR: 0.56; 95% CI: 0.36–0.86; P=0.012) was associated with reduced all-cause mortality. The mortality of patients in Status II of BB or ACEi/ARB was similar to the mortality of those not receiving the drug (HR for BB: 0.90; 95% CI: 0.53–1.52; P=0.69 and HR for ACEi/ARB: 0.71; 95% CI: 0.42–1.18; P=0.182) – figure 1. Achieving Status I of BB remained independently associated with reduced mortality after adjustment for several clinical and echocardiographic confounders (n=13) (adjusted HR: 0.59; 95% CI: 0.35–0.98; P=0.041). Conclusions In this real-world population of patients with HFrEF, the vast majority of patients were in Status I of BB and ACEi/ARB therapy. Achieving Status I of BB therapy seems to be associated with reduced mortality, even after adjustment for several markers of disease severity, highlighting the need for uptitration of medical therapy to maximal tolerated doses according to trial-proven regimens. FUNDunding Acknowledgement Type of funding sources: None.

Baseline characteristics and clinical features of patients with heart failure with reduced ejection fraction: a European real-world, non-interventional registry study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
U Zeymer ◽  
L.H Lund ◽  
V Barrios ◽  
C Fonseca ◽  
A.L Clark ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Real World ◽  
Nyha Class ◽  
Funding Source ◽  
Class Iii ◽  
Reduced Ejection Fraction ◽  
Cardioverter Defibrillator ◽  
Real World Setting ◽  
The Mean

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

scholarly journals MORTALITY AND GUIDELINE DIRECTED MEDICAL THERAPY IN HEART FAILURE PATIENTS WITH REDUCED EJECTION FRACTION: EVIDENCE FROM REAL WORLD DATA

2021 ◽  
Vol 77 (18) ◽  
pp. 670
Author(s):  
Peter A. McCullough ◽  
Hirsch Mehta ◽  
Colin Barker ◽  
Joanna Van Houten ◽  
Sarah Mollenkopf ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Medical Therapy ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
Reduced Ejection Fraction ◽  
Heart Failure Patients

An Early View of Real-World Patient Response to Sacubitril/Valsartan: A Retrospective Study of Patients with Heart Failure with Reduced Ejection Fraction

2018 ◽  
Vol 35 (6) ◽  
pp. 785-795 ◽  
Author(s):  
Dana Drzayich Antol ◽  
Adrianne Waldman Casebeer ◽  
Richard W. DeClue ◽  
Stephen Stemkowski ◽  
Patricia A. Russo
Keyword(s):  
Heart Failure ◽  
Retrospective Study ◽  
Ejection Fraction ◽  
Real World ◽  
Patient Response ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure ◽  
Early View

HFrEF pharmacological treatment: ivabradine

ESC CardioMed ◽  
2018 ◽  
pp. 1863-1867
Author(s):  
Michel Komajda
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Heart Rate ◽  
Chronic Heart Failure ◽  
Ejection Fraction ◽  
Sinus Rhythm ◽  
Pharmacological Treatment ◽  
Beta Blockers ◽  
Reduced Ejection Fraction ◽  
Background Therapy

Ivabradine slows down the heart rate through a blockade of the funny current channels in the sinoatrial node cells. The efficacy of the drug was tested in a large outcome clinical trial in stable chronic heart failure with reduced ejection fraction, in sinus rhythm, on a contemporary background therapy including beta blockers.

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