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Background Oral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes. Type 2 diabetes is commonly associated with renal impairment, restricting treatment options. We aimed to investigate the efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment. Methods This randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries. Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1•73 m², and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without metformin for the past 90 days were eligible. Participants were randomly assigned (1:1) by use of an interactive web-response system, with stratification by glucose-lowering medication and renal function, to receive oral semaglutide (dose escalated to 14 mg once daily) or matching placebo for 26 weeks, in addition to background medication. Participants and site staff were masked to assignment. Two efficacy-related estimands were defined: treatment policy (regardless of treatment discontinuation or rescue medication) and trial product (on treatment without rescue medication) in all participants randomly assigned. Endpoints were change from baseline to week 26 in HbA1c (primary endpoint) and bodyweight (confirmatory secondary endpoint), assessed in all participants with sufficient data. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered on ClinicalTrials.gov, number NCT02827708, and the European Clinical Trials Registry, number EudraCT 2015-005326-19, and is now complete.

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Background: Decompensated heart failure patients are characterised by functional dependence and low exercise tolerance. Aerobic exercise can improve symptoms, functional capacity and an increase in exercise tolerance. However, the benefits of early rehabilitation have not yet been validated. Objective: To evaluate the safety and feasibility of an aerobic exercise training programme in functional capacity of decompensated heart failure patients. Methodology: A single centre, parallel, randomised controlled, open label trial, with 100 patients. The training group (TG, n=50) performed the training protocol and the control group (CG, n=50) performed the usual rehabilitation procedures. The London chest activity of daily living (LCADL) scale, the Barthel index (BI) and the 6 minute walking test (6MWT) at discharge were used to evaluate the efficacy of the protocol. Safety was measured by the existence of adverse events. Results: The mean age of the patients was 70 years, 20% were New York Heart Association (NYHA) class IV and 80% NYHA class III at admission. The major heart failure aetiology was ischaemic (35 patients) and valvular disease (25 patients). There were no significant differences between groups at baseline in terms of sociodemographic or pathophysiological characteristics. There was a statistically significant difference of 54.2 meters for the training group ( P=0.026) in the 6MWT and at LCADL 12 versus 16 ( P=0.003), but the BI did not: 96 versus 92 ( P=0.072). No major adverse events occurred. Conclusions: The training protocol demonstrated safety and efficacy, promoting functional capacity. This study elucidated about the benefits of a systematised implementation of physical exercise during the patient’s clinical stabilisation phase, which had not yet been demonstrated. Trial registration: Clinicaltrials.gov NCT03838003, URL: https://clinicaltrials.gov/ct2/show/NCT03838003 .

Background: Physical fitness is an important determinant of quality of life (QoL) in heart failure with preserved ejection fraction (HFpEF) patients. However, how the different physical fitness components correlate with the specific dimensions of QoL in HFpEF patients remains unknown. Objective: To evaluate the association between different physical fitness components and QoL dimensions in HFpEF patients, and, assess which physical fitness components were independently associated to QoL. Methods: Patients with HFpEF were assessed for physical fitness [dynamic balance and mobility (8-foot-up-and go test), upper body strength (handgrip), cardiorespiratory fitness (CRF) (6-minute-walking test) and body composition (body mass index)] and for QoL (Minnesota Living With Heart Failure Questionnaire). Partial correlation was used to verify the association between physical fitness components and QoL dimensions. The determination of independent predictors in QoL dimensions was assessed through stepwise multivariate linear regression analysis. Statistical significance was set at p<0.05. Results: Both CRF and dynamic balance and mobility are significantly associated with the total score and physical dimensions of QoL (p<0.05), but only dynamic balance and mobility were concomitantly associated with the emotional dimension (r=0.597; p=0.004). Dynamic balance and mobility were independently associated with total score (β=0.651; r 2 =0.424; p=0.001), physical (β=0.570; r 2 =0.324; p=0.04) and emotional (β=0.611; r2=0.373 p=0.002) dimensions of QoL. Conclusion: Our data suggests that dynamic balance and mobility better assess QoL than CRF, which is commonly measured in clinical practice. Whether interventions specifically targeting dynamic balance and mobility have different impacts on QoL remains unknown.

Heart failure is often characterised by low exercise capacity and a great impairment of performance in the activities of daily living. The correct management of the disease can prevent the worsening of symptoms and promote a better quality of life. The aims of this study are to understand the relationship of gender and pathophysiological characteristics with self-care behaviour and to evaluate the self-care behaviour in a sample of Portuguese heart failure inpatients, using the Self-Care of Heart Failure Index (SCHFI). A cross-sectional multicentre study enrolling 225 heart failure inpatients from eight hospitals from Portugal was performed. At admission, each patient’s functional capacity was evaluated as well as their self-care behaviour, using the SCHFI Portuguese v6.2. A comparison between self-care behaviour with gender was performed. The patients’ mean age was 68.4 ± 10.7 years old, 68% were male and 82.3% had reduced ejection fraction. A mean value of 47.9, 35.6 and 38.8 points was found in the SCHFI score of the sections self-care maintenance, self-care management and self-care confidence, respectively. Heart failure inpatients present inadequate levels of self-care behaviour. The results do not suggest a relationship between gender and pathophysiological characteristics with self-care behaviour.

Enquadramento: a COVID-19 condicionou o normal funcionamento dos serviços de saúde, obrigando a uma restruturação na capacidade assistencial dos mesmos, especificamente das unidades de reabilitação cardíaca. Objetivos: avaliar o impacte da pandemia na qualidade de vida e nível de atividade física de doentes em programa de reabilitação cardíaca. Metodologia: estudo descritivo transversal. Foram contactados telefonicamente todos os doentes que tiveram de interromper o programa de reabilitação cardíaca hospitalar num hospital da zona norte do pais, avaliando o seu nível de qualidade de vida, com recurso ao questionário EURO-QoL 5D. O rastreio da prática de atividade física foi igualmente efetuado através de um questionário elaborado pelos autores para o efeito. Resultados: foram contactados 37 doentes, maioritariamente do género masculino (81%,1). A qualidade de vida percecionada é significativamente reduzida, sendo o cuidado pessoal o mais afetado. O índice médio de qualidade de vida obtido é de 0,850. Os doentes realizam um nível insuficiente de atividade física, com base nas recomendações europeias. Conclusão: os doentes que interromperam o programa de reabilitação cardíaca, apresentam um nível reduzido de qualidade de vida associado a uma gestão ineficaz do seu regime terapêutico, como consequência da pandemia.

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