Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission: The MESSAGE-HF Randomized Clinical Trial.

Importance: Readmissions after an index heart failure (HF) hospitalization are a major contemporary health care problem. Objective: To evaluate the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after an HF hospitalization. Design, Setting, and Participants: This randomized clinical trial was conducted in 30 HF clinics in Brazil. Patients with left ventricular ejection fraction less than 40% and access to mobile phones were enrolled up to 30 days after an HF admission. Data were collected from July 2019 to July 2022. Intervention: Participants were randomly assigned to a telemonitoring strategy or standard care. The telemonitoring group received 4 daily short message service text messages to optimize self-care, active engagement, and early intervention. Red flags based on feedback messages triggered automatic diuretic adjustment and/or a telephone call from the health care team. Main Outcomes and Measures: The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 180 days. A hierarchical win-ratio analysis incorporating blindly adjudicated clinical events (cardiovascular deaths and HF hospitalization) and variation in NT-proBNP was also performed. Results: Of 699 included patients, 460 (65.8%) were male, and the mean (SD) age was 61.2 (14.5) years. A total of 352 patients were randomly assigned to the telemonitoring strategy and 347 to standard care. Satisfaction with the telemonitoring strategy was excellent (net promoting score at 180 days, 78.5). HF self-care increased significantly in the telemonitoring group compared with the standard care group (score difference at 30 days, -2.21; 95% CI, -3.67 to -0.74; P = .001; score difference at 180 days, -2.08; 95% CI, -3.59 to -0.57; P = .004). Variation of NT-proBNP was similar in the telemonitoring group compared with the standard care group (telemonitoring: baseline, 2593 pg/mL; 95% CI, 2314-2923; 180 days, 1313 pg/mL; 95% CI, 1117-1543; standard care: baseline, 2396 pg/mL; 95% CI, 2122-2721; 180 days, 1319 pg/mL; 95% CI, 1114-1564; ratio of change, 0.92; 95% CI, 0.77-1.11; P = .39). Hierarchical analysis of the composite outcome demonstrated a similar number of wins in both groups (telemonitoring, 49 883 of 122 144 comparisons [40.8%]; standard care, 48 034 of 122 144 comparisons [39.3%]; win ratio, 1.04; 95% CI, 0.86-1.26). Conclusions and Relevance: An intensive telemonitoring strategy applied in the vulnerable period after an HF admission was feasible, well-accepted, and increased scores of HF self-care but did not translate to reductions in NT-proBNP levels nor improvement in a composite hierarchical clinical outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT04062461.

Antivirals for adult patients hospitalised with SARS-CoV-2 infection: a randomised, phase II/III, multicentre, placebo-controlled, adaptive study, with multiple arms and stages. COALITION COVID-19 BRAZIL IX - REVOLUTIOn trial.

Background: Repurposed drugs for treatment of new onset disease may be an effective therapeutic shortcut. We aimed to evaluate the efficacy of repurposed antivirals compared to placebo in lowering SARS-CoV2 viral load of COVID-19 patients. Methods: REVOLUTIOn is a randomised, parallel, blinded, multistage, superiority and placebo controlled randomised trial conducted in 35 centres in Brazil. We include patients aged 18 years or older admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, symptoms onset 9 days or less and SpO2 94% or lower at room air were eligible. All participants were randomly allocated to receive either atazanavir, daclatasvir or sofosbuvir/daclatasvir or placebo for 10 days. The primary outcome was the decay rate (slope) of the SARS-CoV-2 viral load logarithm assessed in the modified intention to-treat population. This trial was registered with ClinicalTrials.gov, number NCT04468087. Findings: Between February 09, 2021, and August 04, 2021, 255 participants were enrolled and randomly assigned to atazanavir (n = 64), daclatasvir (n = 66), sofosbuvir/daclatasvir (n = 67) or placebo (n = 58). Compared to placebo group, the change from baseline to day 10 in log viral load was not significantly different for any of the treatment groups (0.05 [95% CI, -0.03 to 0.12], -0.02 [95% CI, -0.09 to 0.06], and -0.03 [95% CI, -0.11 to 0.04] for atazanavir, daclatasvir and sofosbuvir/daclatasvir groups respectively). There was no significant difference in the occurrence of serious adverse events between treatment groups. Interpretation: No significant reduction in viral load was observed from the use of atazanavir, daclatasvir or sofosbuvir/daclatasvir compared to placebo in hospitalised COVID-19 patients who need oxygen support with symptoms onset 9 days or less. Funding: Ministério da Ciência, Tecnologia e Inovação (MCTI) - Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPQ); Cia Latino-Americana de Medicamentos (Clamed); Cia Industrial H. Carlos Schneider (Ciser); Hospital Research Foundation Incorporation, Australia, HCor São Paulo; Blanver Farmoquímica; Instituto de Tecnologia em Fármacos (Farmanguinhos) da Fundação Oswaldo Cruz (Fiocruz); Coordenação Geral de Planejamento Estratégico (Cogeplan)/Fiocruz; and Fundação de apoio a Fiocruz (Fiotec, VPGDI-054-FIO-20-2-13).

Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE - Coalition V): A double-blind, multicentre, randomised, controlled trial.

Background: Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers. Methods: We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (1:1) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540. Findings: From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52-1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53-1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57-1·04]). Interpretation: In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting. Funding: COALITION COVID-19 Brazil and EMS.

Acute kidney injury after on-pump coronary artery bypass graft surgery.

BACKGROUND: The acute kidney injury (AKI) is a complex disease for which there is no accepted standard definition nowadays. The Acute Kidney Injury Network (AKIN) represents an attempt to standardize the criteria for diagnosis and staging of acute renal dysfunction based on recently published RIFLE criteria, that means, (Risk, Injury, Failure, Loss, and End-stage kidney disease). OBJECTIVES: To evaluate the incidence and associated mortality of AKI in patients submitted to on-pump coronary artery bypass graft surgery (on-pump CABG). METHODS: A total of 817 patients were divided into two groups: negative AKI (-), with 421 patients (51.5%), and positive AKI (+), with 396 patients (48.5%). Increase of 0.3 mg/dL in creatinine or of 50% in creatinine's basal value was considered as AKI. RESULTS: The rate of patient's mortality with or without AKI within 30 days after cardiac surgery was 12.6% and 1.4%, respectively (p<0.0001). In a multivariate logistic regression model, AKI after on-pump CABG was an independent predictor of death within 30 days (OR=6.7; p=0.0002). This group of patients presented a longer period of permanency in intensive care unit (ICU) [median 2 days (2 to 3) versus 3 days (2 to 5); p=0.0001] and a bigger proportion of patients with prolonged permanence in intensive care (>14 days) (14 versus 2%; p=0.0001). CONCLUSION: In the studied population, even a discrete alteration in renal function, based on AKIN criteria, was an independent predictor of death in 30 days after on-pump CABG.

Elevated troponin levels after prolonged supraventricular tachycardia in patient with normal coronary angiography.

The European Society of Cardiology and the American College of Cardiology redefined the concept of myocardial infarction in the presence of highly positive markers of myocardial injury associated with at least one of the following: ischemic symptoms; development of pathologic Q waves on the ECG or ECG changes indicative of ischemia (positive or negative deviation of the ST segment), making troponins one of the most important aspects in the evaluation and stratification of patients with chest pain in the emergency room. However, although troponin gives excellent accuracy in the identification of myocardial necrosis, it is known that it can also be elevated in a series of nonatherosclerotic heart diseases. We present the case of a 49-year-old female patient admitted to the Chest Pain Unit with a history of supraventricular tachycardia associated with chest discomfort, nausea and diaphoresis. During risk stratification, the patient presented with a high serum troponin T level (0.143 ng/ml) but with a normal coronary angiography.

Lesão renal aguda após revascularização do miocárdio com circulação extracorpórea / Lesión renal aguda post-revascularización del miocardio con circulación extracorpórea / Acute kidney injury after on-pump coronary artery bypass graft surgery

FUNDAMENTO: A lesão renal aguda (LRA) é uma doença complexa para a qual, atualmente, não há uma definição padrão aceita. A AKIN (Acute Kidney Injury Network) representa uma tentativa de padronização dos critérios para diagnóstico e estadiamento da LRA, baseando-se nos critérios RIFLE (risk, injury, failure, loss, e end-stage kidney disease), publicados recentemente. OBJETIVOS: Avaliar a incidência e mortalidade associada à LRA em pacientes submetidos à revascularização do miocárdio (RM) com circulação extracorpórea (CEC). MÉTODOS: O total de 817 pacientes foi dividido em dois grupos: LRA negativa (-), com 421 pacientes (51,5 por cento), e LRA positiva (+), com 396 pacientes (48,5 por cento). Foi considerado LRA a elevação da creatinina em 0,3 mg/dl ou aumento em 50 por cento da creatinina em relação a seu valor basal. RESULTADOS: A mortalidade em 30 dias dos pacientes com e sem LRA foi de 12,6 por cento e 1,4 por cento, respectivamente (p < 0,0001). Em um modelo de regressão logística multivariada, LRA após RM com CEC foi preditora independente de óbito em 30 dias (OR 6,7 - p = 0,0002). Esse grupo de pacientes teve maior tempo de permanência em UTI [mediana 2 dias (2 a 3) vs. 3 dias (2 a 5) - p < 0,0001)] e uma maior proporção de pacientes com permanência prolongada na terapia intensiva (> 14 dias) - 14 por cento vs. 2 por cento; p < 0,0001. CONCLUSÃO: Na população estudada, mesmo uma discreta alteração da função renal baseada nos critérios do "Acute Kidney Injury Network - AKIN" foi preditora independente de óbito em 30 dias após RM com CEC.

BACKGROUND: The acute kidney injury (AKI) is a complex disease for which there is no accepted standard definition nowadays. The Acute Kidney Injury Network (AKIN) represents an attempt to standardize the criteria for diagnosis and staging of acute renal dysfunction based on recently published RIFLE criteria, that means, (Risk, Injury, Failure, Loss, and End-stage kidney disease). OBJECTIVES: To evaluate the incidence and associated mortality of AKI in patients submitted to on-pump coronary artery bypass graft surgery (on-pump CABG). METHODS: A total of 817 patients were divided into two groups: negative AKI (-), with 421 patients (51.5 percent), and positive AKI (+), with 396 patients (48.5 percent). Increase of 0.3 mg/dL in creatinine or of 50 percent in creatinine's basal value was considered as AKI. RESULTS: The rate of patient's mortality with or without AKI within 30 days after cardiac surgery was 12.6 percent and 1.4 percent, respectively (p<0.0001). In a multivariate logistic regression model, AKI after on-pump CABG was an independent predictor of death within 30 days (OR=6.7; p=0.0002). This group of patients presented a longer period of permanency in intensive care unit (ICU) [median 2 days (2 to 3) versus 3 days (2 to 5); p=0.0001] and a bigger proportion of patients with prolonged permanence in intensive care (>14 days) (14 versus 2 percent; p=0.0001). CONCLUSION: In the studied population, even a discrete alteration in renal function, based on AKIN criteria, was an independent predictor of death in 30 days after on-pump CABG.

FUNDAMENTO: Lesión renal aguda (LRA) es una compleja enfermedad, la que, actualmente, no tiene definición patrón acepta. AKIN (Acute Kidney Injury Network) representa una tentativa de estandardización de criterios para el diagnostico y estadiamiento de LRA basado en los criterios RIFLE (risk, injury, failure, loss, y end-stage kidney disease) publicados recientemente. OBJETIVO: Evaluar la incidencia y mortalidad asociada a LRA en pacientes sometidos a revascularización del miocardio (RM) con circulación extracorpórea (CEC). MÉTODOS: El total de 817 pacientes fueron divididos en dos grupos: LRA negativa (-), con 421 pacientes (51,5 por ciento), y LRA positiva (+), con 396 pacientes (48,5 por ciento). LRA fue considerada la elevación de creatinina en 0,3 mg/dl el aumento en 50 por ciento de creatinina en relación a su valor basal. RESULTADOS: La mortalidad dentro de 30 días de los pacientes con y sin LRA ha sido de 12,3 y 1,4 por ciento, respectivamente (p<0,0001). En un modelo de regresión logística multivariado, LRA tras RM con CEC fue predictora independiente de óbito en 30 días (OR=6,7; p=0,0002). Ese grupo de pacientes tuvo el mayor tiempo de permanencia en unidad de cuidados intensivos (UCI) (6,0±9,5 días versus 3,4±4,0 días; p<0,0001) y una proporción de pacientes con permanencia prolongada en la terapia intensiva (>14 días), 14 versus 2 por ciento; p<0,0001. CONCLUSIÓN: En la población estudiada, mismo una discreta alteración de la función renal basada en los criterios AKIN ha sido predictora independiente de óbito, en 30 días tras RM con CEC.