Rationale and Design of MinerAlocorticoid Receptor Antagonist Tolerability Study-Heart Failure (ARTS-HF): a Randomized Study of Finerenone Vs. Eplerenone in Patients Who Have Worsening Chronic Heart Failure With Diabetes And/or Chronic Kidney Disease


The MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF; NCT01807221) is a multicentre, randomized, double-blind, active-comparator-controlled, six-parallel-group, phase 2b dose-finding study. In total, 1060 patients with HFrEF and concomitant type 2 diabetes mellitus and/or chronic kidney disease (CKD) will be randomized within 7 days of emergency presentation to hospital for worsening chronic HF to receive finerenone (one of five doses in the range 2.5-20.0 mg once daily) or eplerenone (25 mg every second day to 50 mg once daily for 90 days). The primary objective is to investigate the safety and potential efficacy (measured as the percentage of individuals with a decrease in plasma N-terminal pro-B-type natriuretic peptide [NT-proBNP] of more than 30% relative to baseline at day 90 ± 2) of different oral doses of finerenone compared with eplerenone. Other objectives are to assess the effects of finerenone on a composite clinical endpoint (death from any cause, cardiovascular hospitalizations, or emergency presentations for worsening chronic HF), and on changes in health-related quality of life from baseline.

Authors: Bertram Pitt, Stefan D Anker, Michael Böhm, Mihai Gheorghiade, Lars Køber, Henry Krum, Aldo P Maggioni, Piotr Ponikowski, Adriaan A Voors, Faiez Zannad, Christina Nowack, So-Young Kim, Alexander Pieper, Nina Kimmeskamp-Kirschbaum, Gerasimos Filippatos
Keywords: finerenone, mineralocorticoid receptor antagonist
DOI Number: 10.1002/ejhf.218      Publication Year: 2015

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