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

Sponsor
Cathay General Hospital
Study ID
NCT07442448
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Heart Failure
  • Heart Failure and Mildly Reduced Ejection Fraction
  • Heart Failure and Preserved Ejection Fraction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA). In this study, participants will receive Finerenone in tablet form, administered orally once daily for a duration of 6 months. The dosage (10 mg or 20 mg) will be determined and adjusted according to the participant's baseline estimated glomerular filtration rate (eGFR) and serum potassium levels, following the approved clinical guidelines.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone Intervention Group
    Participants with diabetic kidney disease (DKD) and heart failure (LVEF ≥ 40%) will receive Finerenone (Kerendia) orally once daily for 6 months. The starting dose (10 mg or 20 mg) is determined based on the participant's baseline estimated glomerular filtration rate (eGFR) and serum potassium levels, according to the approved labeling. Advanced cardiac imaging, including Cardiac Magnetic Resonance (CMR) and MR Spectroscopy (MRS), will be performed at baseline and after the 6-month treatment period to evaluate changes in myocardial remodeling.

Primary Outcome Measure

Change from baseline in Myocardial Extracellular Volume fraction (ECV) [ Time Frame: Baseline and 6 months ]

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