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

NCT07442448 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Finerenone

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.

Sponsors & Collaborators

  • Cathay General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07442448 on ClinicalTrials.gov