Application of eligibility criteria from DAPA-HF, EMPEROR-Reduced, and PARADIGM-HF trials to a population with heart failure with reduced ejection fraction at a specialized cardiology Clinic in Medellin, Colombia: A Retrospective Cohort Study

ABSTRACT: Introduction: The evidence for the pharmacological treatment of heart failure is based on randomized clinical trials with strict inclusion and exclusion criteria. Objectives: To evaluate the proportion of patients with chronic heart failure from an outpatient cohort who would be eligible for the trials DAPA-HF, EMPEROR-reduced, and PARADIGM-HF, and to determine potential differences between study populations. Methods: Through revision of medical records, we calculated the proportion of patients who would have been eligible for each study and evaluated the incidence of heart failure hospitalizations and all-cause mortality during this period. Results: A total of 446 patients were included in the cohort. Approximately 75% would be ineligible for the trials, mainly because of their comorbidities. Ineligible patients had a higher all-cause mortality, but a similar incidence of hospitalization. Conclusion: Approximately 1 in 4 patients from a heart failure clinic in Medellin, Colombia would meet the eligibility criteria for the DAPA-HF, EMPEROR-reduced, and PARADIGM-HF trials. These findings highlight the need to complement randomized clinical trials with real-world data.

• Autores: González Franco, Juliana; Caicedo Espinosa, Javier Eduardo; Cardona Tobón, Carolina; Jaramillo Jara, Natalia; Aguilar Molina, Oswaldo; Jaimes Barragán, Fabian; Saldarriaga Giraldo, Clara Ines
• Tipo de recurso: Tesis
• Fecha de publicación: 2023
• Institución: Universidad de Antioquia
• Repositorio: Repositorio UdeA
• Idioma: eng
• OAI Identifier: oai:bibliotecadigital.udea.edu.co:10495/35809
• Acceso en línea: https://hdl.handle.net/10495/35809
• Palabra clave: Insuficiencia cardiaca; Heart failure; Ensayos clínicos controlados aleatorios como asunto; Randomized controlled trials as topic; Determinación de la elegibilidad; Eligibility determination; https://id.nlm.nih.gov/mesh/D006333; https://id.nlm.nih.gov/mesh/D016032; https://id.nlm.nih.gov/mesh/D004608
• Rights: openAccess
• License: https://creativecommons.org/licenses/by/4.0/