Abstract:
:Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way.
journal_name
Eur J Heart Failjournal_title
European journal of heart failureauthors
Cowie MR,Filippatos GS,Alonso Garcia MLA,Anker SD,Baczynska A,Bloomfield DM,Borentain M,Bruins Slot K,Cronin M,Doevendans PA,El-Gazayerly A,Gimpelewicz C,Honarpour N,Janmohamed S,Janssen H,Kim AM,Lautsch D,Laws I,Lefkdoi
10.1002/ejhf.809subject
Has Abstractpub_date
2017-06-01 00:00:00pages
718-727issue
6eissn
1388-9842issn
1879-0844journal_volume
19pub_type
杂志文章,评审abstract:AIMS:The most recent European guidelines have proposed new definitions of pulmonary hypertension (PH) in left heart disease, to better approach the characteristics required to reflect the presence of pulmonary vascular disease. The purpose of this study was to assess whether different haemodynamic definitions of post-c...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.1067
更新日期:2018-04-01 00:00:00
abstract:AIMS:Recent studies have shown that microRNAs (miRNAs), besides being potent regulators of gene expression, can additionally serve as circulating biomarkers of disease. The aim of this study is to determine if plasma miRNAs can be used as indicators of disease progression or therapeutic efficacy in hypertension-induced...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1093/eurjhf/hft018
更新日期:2013-06-01 00:00:00
abstract:BACKGROUND:Limited comparative studies assessing the health-related quality of life (HRQL) in heart failure (HF) patients with preserved vs. low ejection fraction (LVEF) have been disparate. AIMS:The aims of this study were a) to characterize HRQL in a large population of HF patients with preserved and low LVEF and b)...
journal_title:European journal of heart failure
pub_type: 杂志文章,多中心研究
doi:10.1016/j.ejheart.2006.10.012
更新日期:2007-01-01 00:00:00
abstract:AIM:To investigate the role of MMP-2 and MMP-9 in cardiac remodelling induced by tobacco smoke exposure in rats. METHODS:Rats were allocated into two groups: C (n=9): control animals; ETS (n=9): exposed to tobacco smoke. After 4months, the animals underwent echocardiography, morphometric study and determination of MMP...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/j.ejheart.2007.09.004
更新日期:2007-11-01 00:00:00
abstract:AIMS:Impaired tissue perfusion is often observed in patients with acute heart failure. We tested whether low-dose nitroglycerin (NTG) improves microcirculatory perfusion in patients admitted for acute heart failure. METHODS AND RESULTS:In 20 acute heart failure patients, NTG was given as intravenous infusion at a fixe...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1093/eurjhf/hfp021
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:Oxygen (O2) uptake at peak exercise (VO2 peak) is an objective measurement of functional capacity in patients with chronic heart failure (CHF). The significance of recovery O2 kinetics parameters in predicting exercise capacity, and the parameters of submaximal exercise testing have not been thoroughly exami...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/s1388-9842(01)00187-8
更新日期:2001-12-01 00:00:00
abstract:AIMS:Urine proteome analysis (UPA) has already provided accurate discriminatory patterns of urinary peptides for renal disease, coronary artery disease, and asymptomatic LV diastolic dysfunction. UPA has now been used to characterize a discriminatory peptide biomarker pattern and establish a diagnostic classifier for h...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.544
更新日期:2016-07-01 00:00:00
abstract:AIMS:We evaluated the applicability and prognostic importance of oral glucose tolerance testing (OGTT) among outpatients with systolic heart failure (SHF). METHODS AND RESULTS:Consecutive patients with SHF and left ventricular ejection fraction (LVEF) ≤ 45% referred to a heart failure clinic (n= 413) were included in ...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1093/eurjhf/hfq216
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVE:Infused C-type natriuretic peptide (CNP) was recently found to play a cardioprotective role in preventing myocardial ischaemia/reperfusion (I/R) injury and improving cardiac remodelling after myocardial infarction (MI) in rats. Our study aimed to investigate the effect of cardiomyocyte-specific CNP over-expre...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/j.ejheart.2007.02.006
更新日期:2007-06-01 00:00:00
abstract:BACKGROUND:Clinical trials, the gold standard for the evaluation of new therapeutic strategies, may prove a drug to be beneficial, harmful or neutral according to its effect on the end-point(s) under study. AIMS:To study the reaction and perspective of the patients participating in a clinical heart failure trial, part...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/s1388-9842(00)00151-3
更新日期:2001-03-01 00:00:00
abstract:AIMS:Heart failure (HF) is common in geriatric patients. Clinicians face diagnostic challenges primarily due to comorbidity and limited access to echocardiography. The purpose of this study was to identify independent determinants of the presence of HF in geriatric outpatients and to determine the optimal diagnostic st...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1093/eurjhf/hfr021
更新日期:2011-05-01 00:00:00
abstract:AIMS:The purpose of this study was to determine the prognostic significance and associated clinical profile of early post-discharge N-terminal pro-B-type natriuretic peptide (NT-proBNP) trajectory among patients hospitalized for worsening chronic heart failure (HHF). METHODS AND RESULTS:This post-hoc analysis of the A...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.201
更新日期:2015-01-01 00:00:00
abstract:AIMS:To identify novel risk markers for incident heart failure using proteomic profiling of 80 proteins previously associated with cardiovascular pathology. METHODS AND RESULTS:Proteomic profiling (proximity extension assay) was performed in two community-based prospective cohorts of elderly individuals without heart ...
journal_title:European journal of heart failure
pub_type: 杂志文章,多中心研究
doi:10.1002/ejhf.980
更新日期:2018-01-01 00:00:00
abstract:AIMS:We sought to describe the frequency, type and timing of clinical events, and delineate patterns in their transitions, after a first episode of heart failure (HF). METHODS AND RESULTS:In 1036 Framingham participants with new-onset HF (mean age 79 years; 53% women), we used mixture models to estimate probabilities ...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.1918
更新日期:2020-10-01 00:00:00
abstract:BACKGROUND:New-onset atrial fibrillation (AF) after acute myocardial infarction (AMI) frequently occurs in association with postinfarction complications, particularly with heart failure (HF). AIMS:To evaluate whether postinfarction HF is associated with the subsequent development of AF and whether AF independently pre...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/j.ejheart.2004.07.018
更新日期:2005-06-01 00:00:00
abstract:BACKGROUND:Plasma concentrations of atrial natriuretic peptides are correlated with atrial pressures, as are left ventricular ejection fraction and left ventricular filling abnormalities. AIMS:This study investigated the relation of atrial natriuretic peptides to both left ventricular systolic and diastolic function i...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/s1388-9842(98)00005-1
更新日期:1999-03-01 00:00:00
abstract:BACKGROUND:Hospital management of CHF and predictors of hospital mortality remain unclear. METHODS:To address these issues, we analyzed the hospital admissions for CHF during 1996 in a large university hospital. Patients discharged with the principal diagnosis of CHF were considered eligible for the study. RESULTS:Am...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/s1388-9842(01)00204-5
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:Although discontinuation of chronic ACE inhibitor (ACEi) therapy after myocardial infarction (MI) is common in clinical practice, some clinical studies reported an increased incidence of ischemia-related events after withdrawal. To further address this issue, we assessed hemodynamic, neurohormonal and vascul...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/j.ejheart.2005.04.014
更新日期:2006-03-01 00:00:00
abstract::Ventricular assist device implantation has become an established therapy in adults and children for bridging to heart transplantation or to aid myocardial recovery. Recently, implantation of left ventricular assist devices as definitive therapy has been recognized as a better option than pharmacological treatment in p...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1016/j.ejheart.2006.02.003
更新日期:2006-11-01 00:00:00
abstract:AIMS:In amyloid patients, cardiac involvement dramatically worsens functional capacity and prognosis. We sought to study how the cardiopulmonary exercise test (CPET) could help in functional assessment and risk stratification of patients with cardiac amyloidosis (CA). METHODS AND RESULTS:We carried out a multicentre s...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.2016
更新日期:2020-10-02 00:00:00
abstract:AIMS:Right ventricular (RV) dysfunction has been associated with a worse outcome in heart failure patients undergoing CRT. However, evidence on the RV response to CRT is controversial and there are no data regarding the early effects of CRT on RV function (RVF). We sought to investigate whether a CRT device favourably ...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.450
更新日期:2016-02-01 00:00:00
abstract:AIM:Heart failure (HF) is a common condition with which high mortality, morbidity, and poor quality of life are associated. It has previously been shown that use of HF management programmes (HFMPs) in HF clinics can be beneficial. The purpose of this study was to evaluate if the use of HFMPs also has beneficial effects...
journal_title:European journal of heart failure
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1093/eurjhf/hfs159
更新日期:2013-02-01 00:00:00
abstract:AIMS:To compare the effects of lipophilic simvastatin and hydrophilic rosuvastatin on plasma adiponectin and glycated haemoglobin A1c (HbA1c) levels in patients with non-ischaemic chronic heart failure (NICHF). METHODS AND RESULTS:Seventy-one stable outpatients with NICHF, who were already receiving standard therapy f...
journal_title:European journal of heart failure
pub_type: 杂志文章,随机对照试验
doi:10.1093/eurjhf/hfp144
更新日期:2009-12-01 00:00:00
abstract:AIMS:To determine the association between obesity and outcomes in post-acute myocardial infarction (AMI) patients with systolic heart failure (HF). METHODS AND RESULTS:Of the 6632 Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) participants, 6611 had data on baseline bod...
journal_title:European journal of heart failure
pub_type: 杂志文章,随机对照试验
doi:10.1093/eurjhf/hfq043
更新日期:2010-06-01 00:00:00
abstract:AIMS:Rho kinases (ROCKs) are the best characterized effectors of the small G-protein RhoA, and play a role in enhanced vasoconstriction in animal models of congestive heart failure (CHF). This study examined if ROCK activity is increased in CHF and how it is associated with the outcome in CHF. METHODS AND RESULTS:Pati...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1093/eurjhf/hfs068
更新日期:2012-09-01 00:00:00
abstract:BACKGROUND:Several studies have shown that cardiac-resynchronization therapy (CRT) improves haemodynamic function, cardiac symptoms, and heart rate variability (HRV) and reduces the risk of mortality and sudden death in subjects with chronic heart failure (CHF). In subjects with CHF, power spectral values for the low-f...
journal_title:European journal of heart failure
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.ejheart.2006.01.008
更新日期:2006-11-01 00:00:00
abstract:AIMS:The primary objective of this systematic review was to estimate the prevalence and temporal changes in chronic comorbid conditions reported in heart failure (HF) clinical trials. METHODS AND RESULTS:We searched MEDLINE for HF trials enrolling more than 400 patients published between 2001 and 2016.Trials were divi...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.1818
更新日期:2020-06-01 00:00:00
abstract:AIMS:Women with heart failure (HF) are under-represented in individual randomized clinical trials (RCTs). Little is known about sex-specific treatment effects in HF medications. We evaluated sex differences in the response to mineralocorticoid receptor antagonists (MRAs) in major HF MRA trials, including a broad spectr...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.1740
更新日期:2020-05-01 00:00:00
abstract:AIMS:Liver X receptors (LXRs) transcriptionally regulate inflammation, metabolism, and immunity. Synthetic LXR agonists have been evaluated for their efficacy in the cardiovascular system; however, they elicit prolipogenic side effects which substantially limit their therapeutic use. AZ876 is a novel high-affinity LXR ...
journal_title:European journal of heart failure
pub_type: 杂志文章
doi:10.1002/ejhf.243
更新日期:2015-03-01 00:00:00
abstract:AIMS:To investigate the prevalence of iron deficiency (ID) in heart failure (HF) patients with normal vs. abnormal red cell indices (RCI), the associations between iron parameters and RCI, and prognostic consequences of ID independently of RCI. METHODS AND RESULTS:We analysed clinical data of 1821 patients with HF [me...
journal_title:European journal of heart failure
pub_type: 杂志文章,多中心研究
doi:10.1002/ejhf.820
更新日期:2018-01-01 00:00:00