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

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

Research output: Contribution to journalArticle

52 Citations (Scopus)

Abstract

Aims: To investigate the safety and potential efficacy of the novel non-steroidal mineralocorticoid receptor antagonist finerenone in patients with worsening chronic heart failure and reduced left ventricular ejection fraction (HFrEF) and at high risk of hyperkalaemia and worsening renal dysfunction. Methods and results: 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. Conclusions: ARTS-HF is the first phase 2b clinical trial to investigate the effects of finerenone on plasma NT-proBNP in a high-risk population of patients who have worsening chronic HF with type 2 diabetes mellitus and/or CKD presenting at the emergency department.

Original languageEnglish
Pages (from-to)224-232
Number of pages9
JournalEuropean Journal of Heart Failure
Volume17
Issue number2
DOIs
Publication statusPublished - Feb 1 2015

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Mineralocorticoid Receptor Antagonists
Chronic Renal Insufficiency
Heart Failure
Brain Natriuretic Peptide
Stroke Volume
Type 2 Diabetes Mellitus
Emergencies
Safety
Hyperkalemia
Hospital Emergency Service
Cause of Death
Hospitalization
Quality of Life
BAY 94-8862
eplerenone
Clinical Trials
Kidney
Population

Keywords

  • Antagonist
  • Chronic kidney disease
  • Heart failure
  • Mineralocorticoid receptor
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

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. / Pitt, Bertram; Anker, Stefan D.; Böhm, Michael; Gheorghiade, Mihai; Køber, Lars; Krum, Henry; Maggioni, Aldo P.; Ponikowski, Piotr; Voors, Adriaan A.; Zannad, Faiez; Nowack, Christina; Kim, So Young; Pieper, Alexander; Kimmeskamp-Kirschbaum, Nina; Filippatos, Gerasimos.

In: European Journal of Heart Failure, Vol. 17, No. 2, 01.02.2015, p. 224-232.

Research output: Contribution to journalArticle

Pitt, B, Anker, SD, Böhm, M, Gheorghiade, M, Køber, L, Krum, H, Maggioni, AP, Ponikowski, P, Voors, AA, Zannad, F, Nowack, C, Kim, SY, Pieper, A, Kimmeskamp-Kirschbaum, N & Filippatos, G 2015, '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', European Journal of Heart Failure, vol. 17, no. 2, pp. 224-232. https://doi.org/10.1002/ejhf.218
Pitt, Bertram ; Anker, Stefan D. ; Böhm, Michael ; Gheorghiade, Mihai ; Køber, Lars ; Krum, Henry ; Maggioni, Aldo P. ; Ponikowski, Piotr ; Voors, Adriaan A. ; Zannad, Faiez ; Nowack, Christina ; Kim, So Young ; Pieper, Alexander ; Kimmeskamp-Kirschbaum, Nina ; Filippatos, Gerasimos. / 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. In: European Journal of Heart Failure. 2015 ; Vol. 17, No. 2. pp. 224-232.
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AU - Anker, Stefan D.

AU - Böhm, Michael

AU - Gheorghiade, Mihai

AU - Køber, Lars

AU - Krum, Henry

AU - Maggioni, Aldo P.

AU - Ponikowski, Piotr

AU - Voors, Adriaan A.

AU - Zannad, Faiez

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KW - Mineralocorticoid receptor

KW - Type 2 diabetes mellitus

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