Journal Article

Clinical Utility and Safety of Finerenone in Patients with Heart Failure: Rationale and Design of FINE Registry

Escolar, Vanessa, Díez-Villanueva, Pablo, Gutiérrez de la Varga, Luis, Salazar Mosteiro, Cristina, Recio Mayoral, Alejandro, Boada Lincango, Edison Omar, Aguiar Cano, Diego, Quiles, Juan, Ponz, Inés, Esteban-Fernández, Alberto, Martínez León, Amaia, de Lara Delgado, Gregorio, Bonanad, Clara, Cobo, Marta, Piqueras-Flores, Jesús, Báez-Ferrer, Néstor, del Prado Díaz, Susana, Huerta, Ana, Ferré Vallverdú, Maria, Górriz-Magaña, Juan, Valdivieso-Moré, Sandra, Pastor-Pérez, Francisco J., Alonso Salinas, Gonzalo Luis, González-Manzanares, Rafael, Caravaca-Pérez, Pedro, Almenar, Luis, Gómez-Otero, Inés, Codina, Pau, Pinilla Lozano, María Jesús, González-Calle, David, Gallego, Gonzalo, Fort, Aleix, Viéitez Flórez, José María

2025

Overview

Abstract Aims Information about current use of finerenone in patients with heart failure (HF) finerenone in clinical practice is scarce, and its effectiveness in clinical practice in patients is scarce. We aim to assess both the baseline clinical profile and prognostic role of finerenone in patients with HF, irrespective of ejection fraction. Methods and results The study is a multicentre, observational registry, including regional and tertiary hospitals. The registry incorporates contributions from cardiology, internal medicine, and nephrology departments, ensuring comprehensive data collection. Patients with previous history of decompensated HF and elevated natriuretic peptides (NPs) will be included and classified into two groups: Those initiating finerenone will constitute the study cohort, with a 1:1 matched control cohort including those patients not receiving finerenone. Follow-up will occur at 6 and 12 months (and optional 3 and 5 years). Endpoints will include the incidence of HF exacerbations requiring intravenous therapy, hospitalizations, renal replacement therapy, and mortality due to cardiovascular or renal causes. Conclusions This study will provide valuable real-world evidence on the clinical effectiveness and safety of finerenone across a wide range of HF patients, including those with reduced, mildly reduced, and preserved ejection fraction. By leveraging a large, representative, and controlled cohort, the findings aim to enhance clinical decision-making and optimize the use of finerenone in routine practice, particularly in high-risk patients with complex co-morbidities.

• Publisher: Oxford University Press,John Wiley and Sons Inc,Wiley
• Subject: Cardiovascular disease / Clinical medicine / Clinical outcomes / Clinical trials / Cohort analysis / Diabetes / Diuretics / Drug dosages / Ejection fraction / Ejection fraction spectrum / Electronic health records / Female / Finerenone / Follow-Up Studies / Heart failure / Heart Failure - drug therapy / Heart Failure - physiopathology / Hospitalization / Humans / Hyperkalemia / Informed consent / Ischemia / Kidney diseases / Kidney transplants / Life expectancy / Male / Metabolism / Mineralocorticoid Receptor Antagonists - therapeutic use / Mortality / Multicenter Studies as Topic / Naphthyridines / Observational Studies as Topic / Patients / Peptides / Potassium / Prognosis / Real‐world evidence / Registries / Stroke Volume - drug effects / Stroke Volume - physiology / Study Design