Background Early termination of clinical trials due to low recruitment represents an understudied challenge for clinical research. We aimed to describe characteristics of cardiovascular trials ...terminated because of low recruitment and identify the major predictors of such early termination. Methods We reviewed all cardiovascular clinical trials (7,042 studies) registered in ClinicalTrials.gov from February 29, 2000, to January 17, 2013, and assessed information about trials that were completed and those that were terminated early. Logistic regression models were developed to identify independent predictors of early termination due to low recruitment. Results Our search strategy identified 6,279 cardiovascular clinical trials, of which 684 (10.9%) were terminated prematurely. Of these halted trials, the main reason for termination was lower than expected recruitment (278 trials; 53.6%). When comparing trials that terminated early because of low recruitment with those that were completed, we found that studies funded by the National Institutes of Health or other US federal agencies (odds ratio OR 0.35, 95% confidence interval CI 0.14-0.89), studies of behavior/diet intervention (OR 0.35, 95% CI 0.19-0.65), and single-arm design studies (OR 0.57, 95% CI 0.42-0.78) were associated with a lower risk of early termination. University/hospital-funded (OR 1.52, 95% CI 1.10-2.10) and mixed-source–funded studies (OR 2.14, 95% CI 1.52-3.01) were associated with a higher likelihood of early termination due to lower than expected recruitment rates. Conclusions Low recruitment represents the main cause of early termination of cardiovascular clinical trials. Funding source, type of intervention, and study design are factors associated with early termination due to low recruitment and might be good targets for improving enrollment into cardiovascular clinical trials.
Aims
Exhaled breath acetone (EBA) has been described as a new biomarker of heart failure (HF) diagnosis. EBA concentration increases according to severity of HF and is associated with poor prognosis, ...especially in acute decompensated HF. However, there are no data on chronic HF patients. The aim is to evaluate the role of EBA for predicting cardiac and overall mortality in chronic HF patients.
Methods and results
In GENIUS‐HF cohort, chronic patients were enrolled between August 2012 and December 2014. All patients had left ventricular ejection fraction ≤ 50%, and the diagnosis was established according to Framingham criteria. After consent, patients were submitted to clinical evaluation and exhaled breath collection. EBA identification and quantitative determination were done by spectrophotometry. The clinical characteristics associated with acetone were identified. All participants were followed for 18 months to assess cardiac and overall mortality. Around 700 participants were enrolled in the current analysis. Patients were 55.4 ± 12.2 years old, 67.6% male patients, and 81% New York Heart Association I/II with left ventricular ejection fraction of 32 ± 8.6%. EBA median concentration was 0.6 (0.3–1.2) ug/L. Acetone levels increased with the number of symptoms of HF and were associated with right HF signs/symptoms and liver biochemical changes. EBA at highest quartile (EBA > 1.2ug/L) was associated with a significantly worse prognosis (log rank test, P < 0.001). Cox proportional multivariable regression model revealed that EBA > 1.20ug/L was an independent predictor of cardiac (P = 0.011) and overall (P = 0.010) mortality in our population.
Conclusions
This study shows that EBA levels reflect clinical HF features, especially right HF signs/symptoms. EBA is an independent predictor of cardiac and overall mortality in chronic HF patients.
Heart failure (HF) is one of the leading causes of hospitalization in adults in Brazil. However, most of the available data is limited to unicenter registries. The BREATHE registry is the first to ...include a large sample of hospitalized patients with decompensated HF from different regions in Brazil.
Describe the clinical characteristics, treatment and prognosis of hospitalized patients admitted with acute HF.
Observational registry study with longitudinal follow-up. The eligibility criteria included patients older than 18 years with a definitive diagnosis of HF, admitted to public or private hospitals. Assessed outcomes included the causes of decompensation, use of medications, care quality indicators, hemodynamic profile and intrahospital events.
A total of 1,263 patients (64±16 years, 60% women) were included from 51 centers from different regions in Brazil. The most common comorbidities were hypertension (70.8%), dyslipidemia (36.7%) and diabetes (34%). Around 40% of the patients had normal left ventricular systolic function and most were admitted with a wet-warm clinical-hemodynamic profile. Vasodilators and intravenous inotropes were used in less than 15% of the studied cohort. Care quality indicators based on hospital discharge recommendations were reached in less than 65% of the patients. Intrahospital mortality affected 12.6% of all patients included.
The BREATHE study demonstrated the high intrahospital mortality of patients admitted with acute HF in Brazil, in addition to the low rate of prescription of drugs based on evidence.
Heart failure (HF) is a major public health problem with increasing prevalence worldwide. It is associated with high mortality and poor quality of life due to recurrent and costly hospital ...admissions. Several studies have been conducted to describe HF risk predictors in different races, countries and health systems. Nonetheless, understanding population-specific determinants of HF outcomes remains a great challenge. We aim to evaluate predictors of 1-year survival of individuals with systolic heart failure from the GENIUS-HF cohort.
We enrolled 700 consecutive patients with systolic heart failure from the SPA outpatient clinic of the Heart Institute, a tertiary health-center in Sao Paulo, Brazil. Inclusion criteria were age between 18 and 80 years old with heart failure diagnosis of different etiologies and left ventricular ejection fraction ≤50% in the previous 2 years of enrollment on the cohort. We recorded baseline demographic and clinical characteristics and followed-up patients at 6 months intervals by telephone interview. Study data were collected and data quality assurance by the Research Electronic Data Capture tools. Time to death was studied using Cox proportional hazards models adjusted for demographic, clinical and socioeconomic variables and medication use.
We screened 2314 consecutive patients for eligibility and enrolled 700 participants. The overall mortality was 6.8% (47 patients); the composite outcome of death and hospitalization was 17.7% (123 patients) and 1% (7 patients) have been submitted to heart transplantation after one year of enrollment. After multivariate adjustment, baseline values of blood urea nitrogen (HR 1.017; CI 95% 1.008-1.027; p < 0.001), brain natriuretic peptide (HR 1.695; CI 95% 1.347-2.134; p < 0.001) and systolic blood pressure (HR 0.982;CI 95% 0.969-0.995; p = 0.008) were independently associated with death within 1 year. Kaplan Meier curves showed that ischemic patients have worse survival free of death and hospitalization compared to other etiologies.
High levels of BUN and BNP and low systolic blood pressure were independent predictors of one-year overall mortality in our sample.
Current Controlled Trials NTC02043431, retrospectively registered at in January 23, 2014.
Resumo Fundamento Apesar de progresso significativo na melhoria da qualidade do tratamento de doenças cardiovasculares, lacunas persistem em termos de falha na adesão às recomendações de diretrizes. ...Objetivo Este estudo avalia os efeitos da implementação de um programa de melhoria da qualidade adaptado do Programa Get with the guidelines® da American Heart Association sobre a adesão às diretrizes para síndrome coronária aguda (SCA), fibrilação atrial (FA) e insuficiência cardíaca (IC). Métodos Avaliamos dados demográficos, medidas de qualidade, e desfechos em curto prazo em pacientes com SCA, FA, e IC incluídos no programa Boas Práticas em Cardiologia (BPC) entre 2016 e 2022. Resultados Este estudo incluiu 12167 pacientes em 19 hospitais no Brasil. A idade média foi 62,5 53,8-71 anos, 61,1% eram do sexo masculino, 68,7% apresentaram hipertensão, 32% diabetes mellitus, e 24,1% dislipidemia. Os escores médios compostos tiveram desempenho sustentável entre o período inicial e o último trimestre do seguimento: 65,8±36,2% a 73± 31,2% para FA (p=0,024); 81,0± 23,6% a 89,9 ± 19,3% para IC (p<0,001), e de 88,0 ± 19,1 a 91,2 ± 14,9 para SCA (p<0,001). Conclusões O programa BPC é um programa de melhoria de qualidade no Brasil, em que dados em tempo real, obtidos usando métricas de diretrizes de cardiologia, foram implementados, resultando em uma melhora global no manejo da FA, IC e SCA.
Abstract Background Atrial fibrillation (AF) is an important and growing public health problem worldwide, but data about its actual prevalence, therapeutic management, and clinical outcomes in ...middle- to low-income countries are scarce. Design The First Brazilian Cardiovascular Registry of Atrial Fibrillation (the RECALL study) will assess demographic characteristics and evidence-based practice of a representative sample of patients with AF in Brazil. The prospective, multicenter registry has a planned sample size of 5,000 patients at 80 sites. Eligibility criteria include age >18 years and permanent, paroxysmal, or persistent AF documented by electrocardiogram, 24-hour Holter monitoring, or device interrogation. Patients will be followed through 1 year after enrollment. Information on laboratory tests, echocardiographic data, medication use, and clinical outcomes will be obtained. Various aspects of the population will be described, including demographic characteristics; antithrombotic therapies; level of control of international normalized ratio (by average time within the therapeutic range) among patients using vitamin K antagonists; rates of warfarin discontinuation; outcomes such as death, stroke, systemic embolism, and major bleeding within 1 year after enrollment in the study; and rates of electrical cardioversion, percutaneous ablation of AF, ablation of the atrioventricular junction, and pacemaker/cardioverter-defibrillator implantation. Summary RECALL is the first prospective, multicenter registry of AF in Brazil. This study will provide important information about demographics, practice patterns, treatments, and associated outcomes in patients with AF. The results of this registry will also allow Brazilian data to be put in perspective with other AF registries across the world and provide opportunities to improve care of patients with AF in Brazil.
Resumo Fundamento A fraqueza muscular inspiratória contribui para a intolerância ao exercício e diminuição da qualidade de vida dos pacientes com insuficiência cardíaca. Estudos com treinamento da ...musculatura inspiratória demonstram melhora da força muscular inspiratória, da capacidade funcional e da qualidade de vida. Porém, pouco se sabe sobre a resposta hemodinâmica central (RHC) durante o exercício inspiratório (EI). Objetivo Avaliar a RHC em uma única sessão de EI com diferentes cargas (placebo, 30 e 60%) na insuficiência cardíaca. Métodos Ensaio clínico randomizado placebo-controlado, em pacientes com insuficiência cardíaca com fração de ejeção reduzida, classe funcional II e III. Vinte pacientes, com idade de 65±11 anos, completaram uma sessão única de exercício inspiratório, em 3 ciclos de 15 minutos, com washout de 1 hora, envolvendo cargas de 30% (C30), 60% (C60) e placebo, utilizando um resistor de carga linear ( PowerBreathe Light ). O estudo hemodinâmico não invasivo foi realizado por bioimpedância cardiotorácica ( Niccomo™CardioScreen® ). Análise estatística foi feita com o Teste t de Student e a correlação de Pearson, considerado significante p≤0,05. Resultados Foi observado aumento da frequência cardíaca (FC) com a C30 (64±15 vs 69±15 bpm; p=0,005) e C60 (67±14 vs 73±14 bpm, p=0,002). No volume sistólico (VS), observou-se diminuição com a C30 (73±26 vs 64±20 ml; p=0,004). O débito cardíaco (DC) apresentou aumento apenas com a C60 (4,6±1,5 vs 5,3±1,7 l/min; p=-0,001). Conclusão Quando utilizada a carga de 60%, em uma sessão única de EI, foram observadas alterações na RHC. A FC e o DC aumentaram, assim como as escalas de Borg e sensação subjetiva de dispneia. Já a carga de 30% promoveu diminuição do VS. (Arq Bras Cardiol. 2020; 114(4):656-663)
Robust data comparing long COVID in hospitalized and non-hospitalized patients in middle-income countries are limited.
A retrospective cohort study was conducted in Brazil, including hospitalized and ...non-hospitalized patients. Long COVID was diagnosed at 90-day follow-up using WHO criteria. Demographic and clinical information, including the depression screening scale (PHQ-2) at day 30, was compared between the groups. If the PHQ-2 score is 3 or greater, major depressive disorder is likely. Logistic regression analysis identified predictors and protective factors for long COVID.
A total of 291 hospitalized and 1,118 non-hospitalized patients with COVID-19 were included. The prevalence of long COVID was 47.1% and 49.5%, respectively. Multivariable logistic regression showed female sex (odds ratio OR = 4.50, 95% confidence interval (CI) 2.51-8.37), hypertension (OR = 2.90, 95% CI 1.52-5.69), PHQ-2 > 3 (OR = 6.50, 95% CI 1.68-33.4) and corticosteroid use during hospital stay (OR = 2.43, 95% CI 1.20-5.04) as predictors of long COVID in hospitalized patients, while female sex (OR = 2.52, 95% CI 1.95-3.27) and PHQ-2 > 3 (OR = 3.88, 95% CI 2.52-6.16) were predictors in non-hospitalized patients.
Long COVID was prevalent in both groups. Positive depression screening at day 30 post-infection can predict long COVID. Early screening of depression helps health staff to identify patients at a higher risk of long COVID, allowing an early diagnosis of the condition.
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