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

Abstract

Aims Heart failure (HF) is a highly prevalent and progressive condition associated with significant morbidity and mortalityrates. Acute decompensated HF precipitates millions of hospitalizations each year. Despite therapeutic advances, the overallprognosis of HF is poor. The varying clinical courses and outcomes of patients with this disease may be due toregion-specific gaps and since most HF studies are conducted in developed countries, the participation of Latin Americanand Caribbean countries is low. Considering this, the American Registry of Ambulatory and Acute Decompensated HeartFailure (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 patientswith 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 pre-senting with acute decompensated HF will be included. Follow-up will be performed at 12 months in ambulatory patientsor 1, 6, and 12 months after hospital discharge in acutely decompensated HF patients. This ongoing study began on 1 April2022, with recruitment scheduled to end on 30 November 2023, and follow-up on 31 January 2025. Ethics approval wasobtained 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 formsfor patient groups to enable unbiased analyses. For quantitative variables comparison, we will use the Student’s t-test ornon-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–Meiermethod. 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.