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美国门诊及急性失代偿性心力衰竭注册研究(AMERICCAASS注册研究):原理与设计

American registry of ambulatory and acute decompensated heart failure (AMERICCAASS registry): Rationale and design.

作者信息

Gómez-Mesa Juan Esteban, Gutiérrez-Posso Juliana María, Escalante-Forero Manuela, Eraso-Bolaños David Esteban, Drazner Mark H, Quesada-Chaves Daniel, Romero-Guerra Alexander, Perna Eduardo R, Álvarez-Sangabriel Amada, Rossel Víctor, Alarco Walter, Speranza Mario

机构信息

Department of Cardiology, Fundación Valle del Lili, Cali, Colombia.

Department of Investigation and Innovation, Fundación Valle del Lili, Cali, Colombia.

出版信息

ESC Heart Fail. 2024 Dec;11(6):3805-3813. doi: 10.1002/ehf2.14965. Epub 2024 Jul 16.

DOI:10.1002/ehf2.14965
PMID:39014556
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11631246/
Abstract

AIMS

Heart failure (HF) is a highly prevalent and progressive condition associated with significant morbidity and mortality rates. Acute decompensated HF precipitates millions of hospitalizations each year. Despite therapeutic advances, the overall prognosis of HF is poor. The varying clinical courses and outcomes of patients with this disease may be due to region-specific gaps and since most HF studies are conducted in developed countries, the participation of Latin American and Caribbean countries is low. Considering this, the American Registry of Ambulatory and Acute Decompensated Heart Failure (AMERICCAASS) aims to characterize the population with ambulatory and acute decompensated HF in the American continent and to determine rehospitalization and survival outcomes during the 12 months of follow-up.

METHODS AND RESULTS

AMERICCAASS Registry is an observational, prospective, and hospital-based registry recruiting patients with ambulatory or acute decompensated HF. The registry plans to include between two and four institutions per country from at least 20 countries in the Americas, and at least 60 patients recruited from each participant institution regardless of their ambulatory or acutely decompensated condition. Ambulatory patients with confirmed HF diagnosis or inpatients presenting with acute decompensated HF will be included. Follow-up will be performed at 12 months in ambulatory patients or 1, 6, and 12 months after hospital discharge in acutely decompensated HF patients. This ongoing study began on 1 April 2022, with recruitment scheduled to end on 30 November 2023, and follow-up on 31 January 2025. Ethics approval was obtained from the Biomedical Research Ethics Committee of Fundación Valle del Lili. Data collected in the AMERICCAASS registry is being stored on the electronic platform REDCap (Research Electronic Data Capture), which allows different forms for patient groups to enable unbiased analyses. For quantitative variables comparison, we will use the Student's t-test or non-parametric tests accordingly. Categorical variables will be presented as proportions, and groups will be compared with Fisher's exact test. The significance level will be <0.05 for comparisons. Readmissions and post-discharge mortality will be calculated as proportions at 1, 6, and 12 months, with a survival analysis by conditional probability and the Kaplan-Meier method.

CONCLUSIONS

AMERICCAASS Registry is intended to be the most important registry of the continent for obtaining important information about demographics, aetiology, co-morbidities, and treatment received, either ambulatory or hospitalized. This registry may contribute to the optimization of national and regional evidence and public policies for the diagnosis and treatment of HF disease.

摘要

目的

心力衰竭(HF)是一种高度流行且呈进行性发展的疾病,具有较高的发病率和死亡率。急性失代偿性HF每年导致数百万例住院治疗。尽管治疗取得了进展,但HF的总体预后仍然很差。该疾病患者不同的临床病程和结局可能归因于地区性差异,而且由于大多数HF研究是在发达国家开展的,拉丁美洲和加勒比地区国家的参与度较低。考虑到这一点,美洲门诊和急性失代偿性心力衰竭登记处(AMERICCAASS)旨在对美洲大陆门诊和急性失代偿性HF患者群体进行特征描述,并确定随访12个月期间的再住院率和生存结局。

方法和结果

AMERICCAASS登记处是一项基于医院的观察性前瞻性登记研究,招募门诊或急性失代偿性HF患者。该登记处计划从美洲至少20个国家的每个国家纳入两至四家机构,并且从每个参与机构招募至少60名患者,无论其为门诊患者还是急性失代偿患者。确诊HF的门诊患者或出现急性失代偿性HF的住院患者将被纳入。门诊患者将在12个月时进行随访,急性失代偿性HF患者将在出院后1个月、6个月和12个月进行随访。这项正在进行的研究于2022年4月1日开始,招募计划于2023年11月30日结束,随访于2025年1月31日结束。已获得瓦莱德尔利利基金会生物医学研究伦理委员会的伦理批准。AMERICCAASS登记处收集的数据存储在电子平台REDCap(研究电子数据采集)上,该平台允许针对不同患者群体采用不同形式,以实现无偏分析。对于定量变量比较,我们将相应地使用学生t检验或非参数检验。分类变量将以比例形式呈现,组间比较将采用Fisher精确检验。比较的显著性水平将<0.05。再入院率和出院后死亡率将按1个月、6个月和12个月时的比例计算,并采用条件概率和Kaplan-Meier方法进行生存分析。

结论

AMERICCAASS登记处旨在成为该大陆最重要的登记处,以获取有关人口统计学、病因、合并症以及所接受的门诊或住院治疗的重要信息。该登记处可能有助于优化国家和地区关于HF疾病诊断和治疗的证据及公共政策。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe6c/11631246/19a6dd38bd15/EHF2-11-3805-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe6c/11631246/a40c345a0b2f/EHF2-11-3805-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe6c/11631246/7bdaae324925/EHF2-11-3805-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe6c/11631246/19a6dd38bd15/EHF2-11-3805-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe6c/11631246/a40c345a0b2f/EHF2-11-3805-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe6c/11631246/7bdaae324925/EHF2-11-3805-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe6c/11631246/19a6dd38bd15/EHF2-11-3805-g001.jpg

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