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1.
Arterioscler Thromb Vasc Biol ; 44(2): e54-e64, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38095109

RESUMO

BACKGROUND: Abdominal aortic calcification (AAC), a marker of vascular disease, is associated with disease in other vascular beds including gastrointestinal arteries. We investigated whether AAC is related to rapid weight loss over 5 years and whether rapid weight loss is associated with 9.5-year all-cause mortality in community-dwelling older women. METHODS: Lateral spine images from dual-energy x-ray absorptiometry (1998/1999) were used to assess AAC (24-point AAC scoring method) in 929 older women. Over 5 years, body weight was assessed at 12-month intervals. Rapid weight loss was defined as >5% decrease in body weight within any 12-month interval. Multivariable-adjusted logistic regression was used to assess AAC and rapid weight loss and Cox regression to assess the relationship between rapid weight loss and 9.5-year all-cause mortality. RESULTS: Mean±SD age of women was 75.0±2.6 years. During the initial 5 years, 366 (39%) women presented with rapid weight loss. Compared with women with low AAC (24-point AAC score 0-1), those with moderate (24-point AAC score 2-5: odds ratio, 1.36 [95% CI, 1.00-1.85]) and extensive (24-point AAC score 6+: odds ratio, 1.59 [95% CI, 1.10-2.31]) AAC had higher odds for presenting with rapid weight loss. Results remained similar after further adjustment for dietary factors (alcohol, protein, fat, and carbohydrates), diet quality, blood pressure, and cholesterol measures. The estimates were similar in subgroups of women who met protein intake (n=599) and physical activity (n=735) recommendations (extensive AAC: odds ratios, 1.81 [95% CI, 1.12-2.92] and 1.58 [95% CI, 1.02-2.44], respectively). Rapid weight loss was associated with all-cause mortality over the next 9.5 years (hazard ratio, 1.49 [95% CI, 1.17-1.89]; P=0.001). CONCLUSIONS: AAC extent was associated with greater risk for rapid weight loss over 5 years in older women, a risk for all-cause mortality. Since the association was unchanged after taking nutritional intakes into account, these data support the possibility that vascular disease may play a role in the maintenance of body weight.


Assuntos
Doenças da Aorta , Calcificação Vascular , Doenças Vasculares , Humanos , Feminino , Idoso , Masculino , Fatores de Risco , Estudos Longitudinais , Calcificação Vascular/etiologia , Envelhecimento , Peso Corporal , Redução de Peso , Aorta Abdominal/diagnóstico por imagem , Doenças da Aorta/etiologia
2.
Am Heart J ; 267: 52-61, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37972677

RESUMO

AIMS: Aims were to evaluate (1) reclassification of patients from heart failure with mildly reduced (HFmrEF) to reduced (HFrEF) ejection fraction when an EF = 40% was considered as HFrEF, (2) role of EF digit bias, ie, EF reporting favouring 5% increments; (3) outcomes in relation to missing and biased EF reports, in a large multinational HF registry. METHODS AND RESULTS: Of 25,154 patients in the European Society of Cardiology (ESC) HF Long-Term registry, 17% had missing EF and of those with available EF, 24% had HFpEF (EF≥50%), 21% HFmrEF (40%-49%) and 55% HFrEF (<40%) according to the 2016 ESC guidelines´ classification. EF was "exactly" 40% in 7%, leading to reclassifying 34% of the HFmrEF population defined as EF = 40% to 49% to HFrEF when applying the 2021 ESC Guidelines classification (14% had HFmrEF as EF = 41% to 49% and 62% had HFrEF as EF≤40%). EF was reported as a value ending with 0 or 5 in ∼37% of the population. Such potential digit bias was associated with more missing values for other characteristics and higher risk of all-cause death and HF hospitalization. Patients with missing EF had higher risk of all-cause and CV mortality, and HF hospitalization compared to those with recorded EF. CONCLUSIONS: Many patients had reported EF = 40%. This led to substantial reclassification of EF from old HFmrEF (40%-49%) to new HFrEF (≤40%). There was considerable digit bias in EF reporting and missing EF reporting, which appeared to occur not at random and may reflect less rigorous overall care and worse outcomes.


Assuntos
Insuficiência Cardíaca , Função Ventricular Esquerda , Humanos , Volume Sistólico , Prognóstico , Causas de Morte
3.
Am J Nephrol ; 2024 Aug 19.
Artigo em Inglês | MEDLINE | ID: mdl-39159624

RESUMO

INTRODUCTION: Renin-angiotensin-aldosterone system inhibitor (RAASis; including mineralocorticoid receptor antagonists [MRAs]) benefits are greatest in patients with heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease (CKD); however, the risk of hyperkalemia (HK) is high. METHODS: The DIAMOND trial (NCT03888066) assessed the ability of patiromer to control serum potassium (sK+) in patients with HFrEF with/without CKD. Prior to randomization (double-blind withdrawal, 1:1), patients on patiromer had to achieve ≥50% recommended doses of RAASi and 50 mg/day of MRA with normokalemia during a run-in period. The present analysis assessed the effect of baseline estimated glomerular filtration rate (eGFR) in subgroups of ≥/<60, ≥/<45 (prespecified), and ≥/<30 mL/min/1.73 m2 (added post hoc). RESULTS: In total, 81.3%, 78.9%, and 81.1% of patients with eGFR <60, <45, and <30 mL/min/1.73 m2 at screening achieved RAASi/MRA targets. A greater efficacy of patiromer vs placebo to control sK+ in patients with more advanced CKD was reported (p-interaction ≤ 0.027 for all eGFR subgroups). Greater effects on secondary endpoints were observed with patiromer vs placebo in patients with eGFR <60 and <45 mL/min/1.73 m2. Adverse effects were similar between patiromer and placebo across subgroups. CONCLUSION: Patiromer enabled use of RAASi, controlled sK+, and minimized HK risk in patients with HFrEF, with greater effect sizes for most endpoints noted in patient subgroups with lower eGFR. Patiromer was well tolerated by patients in all eGFR subgroups.

4.
Transpl Int ; 37: 13191, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39015154

RESUMO

Little is known either about either physical activity patterns, or other lifestyle-related prevention measures in heart transplantation (HTx) recipients. The history of HTx started more than 50 years ago but there are still no guidelines or position papers highlighting the features of prevention and rehabilitation after HTx. The aims of this scientific statement are (i) to explain the importance of prevention and rehabilitation after HTx, and (ii) to promote the factors (modifiable/non-modifiable) that should be addressed after HTx to improve patients' physical capacity, quality of life and survival. All HTx team members have their role to play in the care of these patients and multidisciplinary prevention and rehabilitation programmes designed for transplant recipients. HTx recipients are clearly not healthy disease-free subjects yet they also significantly differ from heart failure patients or those who are supported with mechanical circulatory support. Therefore, prevention and rehabilitation after HTx both need to be specifically tailored to this patient population and be multidisciplinary in nature. Prevention and rehabilitation programmes should be initiated early after HTx and continued during the entire post-transplant journey. This clinical consensus statement focuses on the importance and the characteristics of prevention and rehabilitation designed for HTx recipients.


Assuntos
Insuficiência Cardíaca , Transplante de Coração , Qualidade de Vida , Humanos , Consenso , Europa (Continente) , Exercício Físico , Insuficiência Cardíaca/reabilitação , Insuficiência Cardíaca/cirurgia , Transplante de Coração/efeitos adversos , Sociedades Médicas
5.
Heart Vessels ; 39(1): 86-94, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37537380

RESUMO

Patients with heart failure (HF) are at a higher risk of rehospitalisation. In this study, we investigated the prognostic utility of galectin-3 (Gal-3) and NT-proBNP fragments (1-76aa and 13-71aa) as biomarkers to predict outcomes for patients with HF. We collected blood samples from patients with HF (n = 101). Gal-3 and NT-proBNP fragments (1-76aa and 13-71aa) concentrations were measured by immunoassay. Survival analysis and Cox proportional regression models were used to determine the prognostic utility of Gal-3 and NT-proBNP fragments. In patients with increased baseline levels of NT-proBNP1-76 the time to primary endpoint (cardiovascular death or re-hospitalisation) was significantly shorter (p = 0.0058), but not in patient with increased baseline levels of Gal-3 or NTproBNP13-71. Patients with increased levels of NT-proBNP13-71aa at 1 month showed reduced time to the primary endpoint (p = 0.0123). Our findings demonstrated that Gal-3 and NT-proBNP can be used as prognostic biomarkers to stratify patients with HF.


Assuntos
Galectina 3 , Insuficiência Cardíaca , Humanos , Prognóstico , Peptídeo Natriurético Encefálico , Fragmentos de Peptídeos , Biomarcadores , Hospitalização
6.
J Card Fail ; 29(5): 787-804, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-37117140

RESUMO

Natriuretic peptides, brain (B-type) natriuretic peptide (BNP) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) are globally and most often used for the diagnosis of heart failure (HF). In addition, they can have an important complementary role in the risk stratification of its prognosis. Since the development of angiotensin receptor neprilysin inhibitors (ARNIs), the use of natriuretic peptides as therapeutic agents has grown in importance. The present document is the result of the Trilateral Cooperation Project among the Heart Failure Association of the European Society of Cardiology, the Heart Failure Society of America and the Japanese Heart Failure Society. It represents an expert consensus that aims to provide a comprehensive, up-to-date perspective on natriuretic peptides in the diagnosis and management of HF, with a focus on the following main issues: (1) history and basic research: discovery, production and cardiovascular protection; (2) diagnostic and prognostic biomarkers: acute HF, chronic HF, inclusion/endpoint in clinical trials, and natriuretic peptides-guided therapy; (3) therapeutic use: nesiritide (BNP), carperitide (ANP) and ARNIs; and (4) gaps in knowledge and future directions.


Assuntos
Cardiologia , Insuficiência Cardíaca , Peptídeos Natriuréticos , Humanos , Biomarcadores , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/terapia , Peptídeo Natriurético Encefálico/uso terapêutico , Fragmentos de Peptídeos , Prognóstico
7.
Heart Fail Rev ; 28(5): 1141-1149, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37198505

RESUMO

Heart failure (HF) with preserved ejection fraction (HFpEF) causes a progressive limitation of functional capacity, poor quality of life (QoL) and increased mortality, yet unlike HF with reduced ejection fraction (HFrEF) there are no effective device-based therapies. Both HFrEF and HFpEF are associated with dysregulations in myocardial cellular calcium homeostasis and modifications in calcium-handling proteins, leading to abnormal myocardial contractility and pathological remodelling. Cardiac contractility modulation (CCM) therapy, based on a pacemaker-like implanted device, applies extracellular electrical stimulation to myocytes during the absolute refractory period of the action potential, which leads to an increase in cytosolic peak calcium concentrations and thereby the force of isometric contraction promoting positive inotropism. Subgroup analysis of CCM trials in HFrEF has demonstrated particular benefits in patients with LVEF between 35% and 45%, suggesting its potential effectiveness also in patients with higher LVEF values. Available evidence on CCM in HFpEF is still preliminary, but improvements in terms of symptoms and QoL have been observed. Future large, dedicated, prospective studies are needed to evaluate the safety and efficacy of this therapy in patients with HFpEF.


Assuntos
Insuficiência Cardíaca , Função Ventricular Esquerda , Humanos , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia , Qualidade de Vida , Cálcio , Cardiotônicos , Prognóstico
8.
Eur Heart J ; 43(41): 4362-4373, 2022 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-35900838

RESUMO

AIMS: To investigate the impact of patiromer on the serum potassium level and its ability to enable specified target doses of renin-angiotensin-aldosterone system inhibitor (RAASi) use in patients with heart failure and reduced ejection fraction (HFrEF). METHODS AND RESULTS: A total of 1642 patients with HFrEF and current or a history of RAASi-related hyperkalemia were screened and 1195 were enrolled in the run-in phase with patiromer and optimization of the RAASi therapy [≥50% recommended dose of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, and 50 mg of mineralocorticoid receptor antagonist (MRA) spironolactone or eplerenone]. Specified target doses of the RAASi therapy were achieved in 878 (84.6%) patients; 439 were randomized to patiromer and 439 to placebo. All patients, physicians, and outcome assessors were blinded to treatment assignment. The primary endpoint was between-group difference in the adjusted mean change in serum potassium. Five hierarchical secondary endpoints were assessed. At the end of treatment, the median (interquartile range) duration of follow-up was 27 (13-43) weeks, the adjusted mean change in potassium was +0.03 mmol/l in the patiromer group and +0.13 mmol/l in the placebo group [difference in the adjusted mean change between patiromer and placebo: -0.10 mmol/l (95% confidence interval, CI -0.13, 0.07); P < 0.001]. Risk of hyperkalemia >5.5 mmol/l [hazard ratio (HR) 0.63; 95% CI 0.45, 0.87; P = 0.006), reduction of MRA dose (HR 0.62; 95% CI 0.45, 0.87; P = 0.006), and total adjusted hyperkalemia events/100 person-years (77.7 vs. 118.2; HR 0.66; 95% CI 0.53, 0.81; P < 0.001) were lower with patiromer. Hyperkalemia-related morbidity-adjusted events (win ratio 1.53, P < 0.001) and total RAASi use score (win ratio 1.25, P = 0.048) favored the patiromer arm. Adverse events were similar between groups. CONCLUSION: Concurrent use of patiromer and high-dose MRAs reduces the risk of recurrent hyperkalemia (ClinicalTrials.gov: NCT03888066).


Assuntos
Insuficiência Cardíaca , Hiperpotassemia , Humanos , Hiperpotassemia/tratamento farmacológico , Hiperpotassemia/complicações , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/tratamento farmacológico , Volume Sistólico , Antagonistas de Receptores de Mineralocorticoides/efeitos adversos , Sistema Renina-Angiotensina , Potássio
9.
Lancet ; 398(10309): 1427-1435, 2021 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-34474011

RESUMO

BACKGROUND: Mortality remains unacceptably high in patients with heart failure and reduced left ventricular ejection fraction (LVEF) despite advances in therapeutics. We hypothesised that a novel artificial intelligence approach could better assess multiple and higher-dimension interactions of comorbidities, and define clusters of ß-blocker efficacy in patients with sinus rhythm and atrial fibrillation. METHODS: Neural network-based variational autoencoders and hierarchical clustering were applied to pooled individual patient data from nine double-blind, randomised, placebo-controlled trials of ß blockers. All-cause mortality during median 1·3 years of follow-up was assessed by intention to treat, stratified by electrocardiographic heart rhythm. The number of clusters and dimensions was determined objectively, with results validated using a leave-one-trial-out approach. This study was prospectively registered with ClinicalTrials.gov (NCT00832442) and the PROSPERO database of systematic reviews (CRD42014010012). FINDINGS: 15 659 patients with heart failure and LVEF of less than 50% were included, with median age 65 years (IQR 56-72) and LVEF 27% (IQR 21-33). 3708 (24%) patients were women. In sinus rhythm (n=12 822), most clusters demonstrated a consistent overall mortality benefit from ß blockers, with odds ratios (ORs) ranging from 0·54 to 0·74. One cluster in sinus rhythm of older patients with less severe symptoms showed no significant efficacy (OR 0·86, 95% CI 0·67-1·10; p=0·22). In atrial fibrillation (n=2837), four of five clusters were consistent with the overall neutral effect of ß blockers versus placebo (OR 0·92, 0·77-1·10; p=0·37). One cluster of younger atrial fibrillation patients at lower mortality risk but similar LVEF to average had a statistically significant reduction in mortality with ß blockers (OR 0·57, 0·35-0·93; p=0·023). The robustness and consistency of clustering was confirmed for all models (p<0·0001 vs random), and cluster membership was externally validated across the nine independent trials. INTERPRETATION: An artificial intelligence-based clustering approach was able to distinguish prognostic response from ß blockers in patients with heart failure and reduced LVEF. This included patients in sinus rhythm with suboptimal efficacy, as well as a cluster of patients with atrial fibrillation where ß blockers did reduce mortality. FUNDING: Medical Research Council, UK, and EU/EFPIA Innovative Medicines Initiative BigData@Heart.


Assuntos
Antagonistas Adrenérgicos beta/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Análise por Conglomerados , Insuficiência Cardíaca/tratamento farmacológico , Aprendizado de Máquina , Idoso , Comorbidade , Método Duplo-Cego , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Volume Sistólico , Função Ventricular Esquerda
10.
Fam Pract ; 39(5): 805-812, 2022 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-35083480

RESUMO

BACKGROUND: Diagnostic tools available to support general practitioners diagnose heart failure (HF) are limited. OBJECTIVES: (i) Determine the feasibility of the novel cardiac output response to stress (CORS) test in suspected HF patients, and (ii) Identify differences in the CORS results between (a) confirmed HF patients from non-HF patients, and (b) HF reduced (HFrEF) vs HF preserved (HFpEF) ejection fraction. METHODS: Single centre, prospective, observational, feasibility study. Consecutive patients with suspected HF (N = 105; mean age: 72 ± 10 years) were recruited from specialized HF diagnostic clinics in secondary care. The consultant cardiologist confirmed or refuted a HF diagnosis. The patient completed the CORS but the researcher administering the test was blinded from the diagnosis. The CORS assessed cardiac function (stroke volume index, SVI) noninvasively using the bioreactance technology at rest-supine, challenge-standing, and stress-step exercise phases. RESULTS: A total of 38 patients were newly diagnosed with HF (HFrEF, n = 21) with 79% being able to complete all phases of the CORS (91% of non-HF patients). A 17% lower SVI was found in HF compared with non-HF patients at rest-supine (43 ± 15 vs 51 ± 16 mL/beat/m2, P = 0.02) and stress-step exercise phase (49 ± 16 vs 58 ± 17 mL/beat/m2, P = 0.02). HFrEF patients demonstrated a lower SVI at rest (39 ± 15 vs 48 ± 13 mL/beat/m2, P = 0.02) and challenge-standing phase (34 ± 9 vs 42 ± 12 mL/beat/m2, P = 0.03) than HFpEF patients. CONCLUSION: The CORS is feasible and patients with HF responded differently to non-HF, and HFrEF from HFpEF. These findings provide further evidence for the potential use of the CORS to improve HF diagnostic and referral accuracy in primary care.


Heart failure (HF) is a global pandemic affecting 26 million people worldwide with an estimated 1 million people in the United Kingdom. Accurate early diagnosis of HF and the initiation of evidence-based treatment is essential to reduce morbidity and mortality and the associated burden on healthcare. As there are no state-of-the-art approaches, early diagnosis is challenging and often inaccurate, as initial signs and symptoms are nonspecific. We have developed an innovative test, named CORS (cardiac output response to stress test), to help general practitioners identify HF, which uses a method similar to an electrocardiogram and measures heart function at rest and during short step exercise. We recruited suspected HF patients from specialist HF diagnostic clinics in secondary care to complete the CORS test. We successfully demonstrated that 79% of patients with newly diagnosed HF (n = 38) and 91% of non-HF patients (n = 67) were able to complete all phases of the CORS test. Our findings demonstrate that newly diagnosed HF patients are able to complete this test, which provides further evidence for the potential use of the CORS test to improve HF diagnostic and referral accuracy in primary care.


Assuntos
Insuficiência Cardíaca , Idoso , Idoso de 80 Anos ou mais , Débito Cardíaco/fisiologia , Teste de Esforço/métodos , Estudos de Viabilidade , Insuficiência Cardíaca/diagnóstico , Humanos , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Volume Sistólico/fisiologia
11.
Eur Heart J Suppl ; 24(Suppl L): L10-L19, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36545228

RESUMO

The syndrome of heart failure (HF) has historically been dichotomized based on clinical trial inclusion criteria into patients with a reduced or preserved left ventricular ejection fraction (LVEF) using a cut-off of above or below 40%. The majority of trial evidence for the benefits of disease-modifying pharmacological therapy has been in patients with HF with reduced ejection fraction (HFrEF), i.e. those with an LVEF ≤40%. Recently, the sodium-glucose co-transporter 2 inhibitors empagliflozin and dapagliflozin have been shown to be the first drugs to improve outcomes in HF across the full spectrum of LVEF. There is, however, growing evidence that the benefits of many of the neurohumoral modulators shown to be beneficial in patients with HFrEF may extend to those with a higher LVEF above 40% but still below the normal range, i.e. HF with mildly reduced ejection fraction (HFmrEF). Whether the benefits of some of these medications also extend to patients with HF and preserved ejection fraction (HFpEF) is an area of ongoing debate. This article will review the evidence for HF treatments across the full spectrum of LVEF, provide an overview of recently updated clinical practice guidelines, and address the question whether it may now be time to treat HF with some therapies regardless of ejection fraction.

12.
Eur Heart J ; 42(13): 1254-1269, 2021 Mar 31.
Artigo em Inglês | MEDLINE | ID: mdl-33734354

RESUMO

Secondary (or functional) mitral regurgitation (SMR) occurs frequently in chronic heart failure (HF) with reduced left ventricular (LV) ejection fraction, resulting from LV remodelling that prevents coaptation of the valve leaflets. Secondary mitral regurgitation contributes to progression of the symptoms and signs of HF and confers worse prognosis. The management of HF patients with SMR is complex and requires timely referral to a multidisciplinary Heart Team. Optimization of pharmacological and device therapy according to guideline recommendations is crucial. Further management requires careful clinical and imaging assessment, addressing the anatomical and functional features of the mitral valve and left ventricle, overall HF status, and relevant comorbidities. Evidence concerning surgical correction of SMR is sparse and it is doubtful whether this approach improves prognosis. Transcatheter repair has emerged as a promising alternative, but the conflicting results of current randomized trials require careful interpretation. This collaborative position statement, developed by four key associations of the European Society of Cardiology-the Heart Failure Association (HFA), European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Association of Cardiovascular Imaging (EACVI), and European Heart Rhythm Association (EHRA)-presents an updated practical approach to the evaluation and management of patients with HF and SMR based upon a Heart Team approach.

13.
J Card Fail ; 27(7): 727-743, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34022400

RESUMO

Endomyocardial biopsy (EMB) is an invasive procedure, globally most often used for the monitoring of heart transplant rejection. In addition, EMB can have an important complementary role to the clinical assessment in establishing the diagnosis of diverse cardiac disorders, including myocarditis, cardiomyopathies, drug-related cardiotoxicity, amyloidosis, other infiltrative and storage disorders, and cardiac tumors. Improvements in EMB equipment and the development of new techniques for the analysis of EMB samples has significantly improved the diagnostic precision of EMB. The present document is the result of the Trilateral Cooperation Project between the Heart Failure Association of the European Society of Cardiology, Heart Failure Society of America, and the Japanese Heart Failure Society. It represents an expert consensus aiming to provide a comprehensive, up-to-date perspective on EMB, with a focus on the following main issues: (1) an overview of the practical approach to EMB, (2) an update on indications for EMB, (3) a revised plan for heart transplant rejection surveillance, (4) the impact of multimodality imaging on EMB, and (5) the current clinical practice in the worldwide use of EMB.


Assuntos
Insuficiência Cardíaca , Transplante de Coração , Biópsia , Endocárdio , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Humanos , Japão/epidemiologia , Miocárdio
14.
Eur Heart J ; 41(22): 2109-2117, 2020 06 07.
Artigo em Inglês | MEDLINE | ID: mdl-32498081

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.


Assuntos
Betacoronavirus , Ensaios Clínicos como Assunto/métodos , Infecções por Coronavirus , Insuficiência Cardíaca , Pandemias , Pneumonia Viral , Projetos de Pesquisa/normas , COVID-19 , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Europa (Continente) , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/terapia , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Segurança do Paciente , Seleção de Pacientes/ética , SARS-CoV-2
16.
Age Ageing ; 49(1): 16-19, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31697342

RESUMO

Heart failure has a high prevalence in older populations, is a common and growing cause for hospital admission and carries a high risk of morbidity and mortality. Important co-morbidities in older patients with heart failure include atrial fibrillation, renal impairment, hypertension and anaemia. Diagnosing and managing heart failure in older patients are complicated due to atypical presentations, co-morbidities and a relative lack of evidence for commonly used treatments in younger patients. The growing epidemic of heart failure is also under-recognised and resourced in most health systems. Despite potential differences, we recommend that the basic approach to manage heart failure patients with an ejection fraction (EF) of <40% should be the same in older and younger. These treatments need to be started at low doses and titrated slowly along with the management of co-morbidities. Older patients with EF 40-49% can be treated in a similar manner to those with <40%, while the treatment of those with EF ≥50% is pragmatic in nature based on symptom control and management of co-morbidities although the evidence base for these recommendations is lacking. Overall management must be holistic and continuous based on the patient's social circumstances and ongoing needs. Finally, there is an urgent need for more research, evidence and resources directed towards older populations with heart failure to improve their care and the quality of life.


Assuntos
Insuficiência Cardíaca/terapia , Idoso , Insuficiência Cardíaca/diagnóstico , Humanos
17.
Eur Heart J Suppl ; 21(Suppl L): L4-L7, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31885504

RESUMO

Heart failure (HF) is a complex clinical syndrome resulting from structural or functional cardiac disorders. In the developed world, HF is primarily a disorder of the elderly. It is one that is accompanied by many non-cardiac comorbidities that affect treatments given, the patient's response and treatment tolerance and outcomes. Even the pathophysiological mechanisms of HF change as we look at older patient populations. Younger HF patients typically have ischaemic heart disease and HF with reduced ejection fraction (HFrEF), whereas older patients have more hypertension HF with preserved ejection fraction (HFpEF). The prevalence of HF has progressively increased for many years and rises even more steeply with age. The outcomes of older especially HFpEF patients have not progressed as much younger HFrEF cohorts. We need more studies specifically recruiting older HF patients with more comorbidities, to guide real-world practice, and we need more assessment of patient-reported outcomes and quality of life rather than just mortality effects. The management of elderly patients with HF requires a more holistic approach recognizing individual needs and necessary support mechanisms and our future trials need to guide us more in achieving these gains.

18.
Eur Heart J Suppl ; 21(Suppl L): L36-L38, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31885512

RESUMO

With the ageing of populations heart failure is becoming more common and more complex. It is affecting ever older patients and the number of prevalent comorbidities is rising. Even as we continue to gain success in large-scale clinical trials with more effective therapies so our patients are becoming more complex. One of the biggest challenges is the effect of age. Frailty, comorbidity, sarcopaenia, cachexia, polypharmacy, and cognitive decline are all challenging our patients as never before and these challenges will be difficult for cash strapped health care systems to manage. For these reasons, the Heart Failure Association brought together a panel of experts to debate and review this complex area, championing the need for us to establish better ways of caring for the patients of the future.

19.
Eur Heart J Suppl ; 21(Suppl M): M36-M39, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31908614

RESUMO

Sleep-disordered breathing (SDB) is extremely common in heart failure (HF) and it carries with it adverse symptoms and impaired survival. Sleep-disordered breathing has two main types; obstructive sleep apnoea (OSA) and central sleep apnoea (CSA), which can overlap. The differentiation between CSA and OSA is important and is recommended in recent HF guidelines, by recommending a formal sleep study. The reason is that for OSA the main therapy is a positive pressure airway mask, whereas for patients with HFrEF and CSA this mask therapy actually increases cardiovascular mortality, and therefore alternative therapies are required, such as implantable phrenic nerve stimulation to improve sleep and related daytime symptoms attributable to the CSA. This article discusses the detection, screening, and monitoring of SDB in HF patients.

20.
Eur Heart J Suppl ; 21(Suppl M): M17-M19, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31908610

RESUMO

Imaging modalities are used for screening, risk stratification and monitoring of heart failure (HF). In particular, echocardiography represents the cornerstone in the assessment of left ventricular (LV) dysfunction. Despite the well-known limitations of LV ejection fraction, this parameter, repeated assessment of LV function is recommended for the diagnosis and care of patients with HF and provides prognostic information. Left ventricular ejection fraction (LVEF) has an essential role in phenotyping and appropriate guiding of the therapy of patients with chronic HF. This document reflects the key points concerning monitoring LV function discussed at a consensus meeting on physiological monitoring in the complex multi-morbid HF patient under the auspices of the Heart Failure Association of the ESC.

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