Physicians' Academy for Cardiovascular Education

Consistent benefit with non-steroidal MRA in CKD and T2DM patients with and without HF

Finerenone in patients with CKD and T2D with and without heart failure: A prespecified subgroup analysis of the FIDELIO-DKD trial

Literature - Filippatos G, Pitt B, Agarwal R, et al., - Eur J Heart Fail 2022, doi: 10.1002/ejhf.2469.

Introduction and methods


In the FIDELIO-DKD trial, treatment with the non-steroidal MRA finerenone resulted in improvement of kidney function and reduction of CV morbidity and mortality in patients with CKD and T2DM without HFrEF [1,2]. Phase II studies with finerenone showed benefits in patients with HFrEF, with T2DM and/or CKD [3-5]. And mechanistic studies have suggested that MRAs may improve LV diastolic function, but clear benefit has not been shown in patients with HFmrEF or HFpEF in randomized trials [6-8].

In this prespecified analysis of the FIDELIO-DKD trial, the effects of finerenone on CV, kidney, and HF outcomes was examined in patients with and without a history of HF (HFpEF or HFmrEF) at baseline.


FIDELIO-DKD was a multicenter, phase III, randomized, double-blind, placebo-controlled trial. Patients with a clinical diagnosis of T2DM and CKD were included, and patients had to be treated ≥4 weeks with either ACEi or ARB for the screening visit. Patients with HFrEF were excluded.

For this prespecified subgroup analysis, patients with categorized by presence or absence of HF. Of 5674 patients, 436 (7.7%) had a history of HF at baseline.

Median follow-up was 2.6 years (IQR: 2.0-3.4 years).


The composite CV outcome was defined as time to first occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for HF. The composite kidney outcome was time to first occurrence of kidney failure, a sustained decrease of ≥40% in eGFR from baseline to at least 4 weeks, or death from renal causes.

Main results

Effect of finerenone on CV outcomes

Effect of finerenone on kidney outcomes

Effect of finerenone on HF outcomes

Safety outcomes


There was no difference in benefit with finerenone with regard to CV and kidney outcomes in patients with CKD and T2DM between those with and without a history of HF. Also, finerenone was well tolerated both in patients with and without a history of HF.


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Find this article online at Eur J Heart Fail

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