Investigation on the Impact of Finerenone on Myocardial Remodeling in Patients With Diabetic Kidney Disease and Heart Failure

Summary

The goal of this clinical trial is to evaluate the impact of Finerenone on myocardial remodeling in patients with diabetic kidney disease (DKD) and heart failure with a left ventricular ejection fraction (LVEF) ≥ 40%. The main questions it aims to answer are: 1. Does 6-month treatment with Finerenone significantly reduce myocardial fat infiltration (measured by MR Spectroscopy) and myocardial fibrosis (measured by extracellular volume fraction on CMR)? 2. Does Finerenone improve global left ventricular longitudinal systolic strain (GLS) and other structural remodeling indices in this patient population? Researchers will compare cardiac imaging parameters after 6 months of treatment to baseline values to see if Finerenone effectively reverses or slows down pathological cardiac changes. Participants will: 1. Take Finerenone (Kerendia) 10 mg or 20 mg orally once daily for a total of 6 months. 2. Undergo advanced cardiac imaging, including Cardiac Magnetic Resonance (CMR) and MR Spectroscopy (MRS), at the beginning of the study and after 6 months of treatment. 3. Receive regular clinical follow-up and blood tests to monitor safety (such as potassium levels and kidney function) and treatment efficacy.

Timeline

Start

2026-04

Primary completion

2028-12

Completion

2029-12

Publications

• Background Su MY, Lin LY, Tseng YH, Chang CC, Wu CK, Lin JL, Tseng WY. CMR-verified diffuse myocardial fibrosis is associated with diastolic dysfunction in HFpEF. JACC Cardiovasc Imaging. 2014 Oct;7(10):991-7. doi: 10.1016/j.jcmg.2014.04.022. Epub 2014 Sep 17.
• Background Wu CK, Lee JK, Hsu JC, Su MM, Wu YF, Lin TT, Lan CW, Hwang JJ, Lin LY. Myocardial adipose deposition and the development of heart failure with preserved ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):445-454. doi: 10.1002/ejhf.1617. Epub 2019 Sep 11.
• Background Solomon SD, McMurray JJV, Vaduganathan M, Claggett B, Jhund PS, Desai AS, Henderson AD, Lam CSP, Pitt B, Senni M, Shah SJ, Voors AA, Zannad F, Abidin IZ, Alcocer-Gamba MA, Atherton JJ, Bauersachs J, Chang-Sheng M, Chiang CE, Chioncel O, Chopra V, Comin-Colet J, Filippatos G, Fonseca C, Gajos G, Goland S, Goncalvesova E, Kang S, Katova T, Kosiborod MN, Latkovskis G, Lee AP, Linssen GCM, Llamas-Esperon G, Mareev V, Martinez FA, Melenovsky V, Merkely B, Nodari S, Petrie MC, Saldarriaga CI, Saraiva JFK, Sato N, Schou M, Sharma K, Troughton R, Udell JA, Ukkonen H, Vardeny O, Verma S, von Lewinski D, Voronkov L, Yilmaz MB, Zieroth S, Lay-Flurrie J, van Gameren I, Amarante F, Kolkhof P, Viswanathan P; FINEARTS-HF Committees and Investigators. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024 Oct 24;391(16):1475-1485. doi: 10.1056/NEJMoa2407107. Epub 2024 Sep 1.
• Background Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.
• Background Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

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