February 1, 2015Open Access
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
Key Result
The ARTS-HF trial is a phase 2b study designed to evaluate the safety and efficacy of finerenone versus eplerenone on NT-proBNP reduction in 1060 patients with worsening chronic HFrEF.
Study Design
Type
RCT (n=1,060)
Blinding
Double-blind
Randomization
six-parallel-group
Multicenter
Yes
Structured PICO
Does finerenone compared to eplerenone improve NT-proBNP levels and safety in patients with worsening HFrEF and concomitant type 2 diabetes and/or CKD?
P
Population
1060 patients with worsening chronic heart failure and reduced left ventricular ejection fraction (HFrEF) and concomitant type 2 diabetes mellitus and/or chronic kidney disease (CKD), randomized within 7 days of emergency presentation to hospital
I
Intervention
Finerenone (one of five oral doses in the range 2.5-20.0 mg once daily) for 90 days
C
Comparator
Eplerenone (25 mg every second day to 50 mg once daily) for 90 days
O
Outcome
Percentage of individuals with a decrease in plasma NT-proBNP of more than 30% relative to baseline at day 90 ± 2, and safetysurrogate
The ARTS-HF trial is designed to investigate the optimal dose, safety, and efficacy of finerenone compared to eplerenone in high-risk patients with worsening HFrEF and diabetes/CKD.
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.