By InvitationPhase 4

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

Taiwan40 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. \*\*Age and Consent:\*\* * Age ≥ 18 years at the time of signing informed consent. * Capable of giving signed informed consent and willing to comply with all study requirements and restrictions. * 2\. \*\*Type 2 Diabetes and Chronic Kidney Disease (CKD):\*\* * Diagnosis of Type 2 Diabetes Mellitus with chronic kidney disease, defined by either: * Urine albumin-to-creatinine ratio (UACR) 30 to 300 mg/g AND estimated glomerular filtration rate (eGFR) 25 to 90 mL/min/1.73 m², OR * UACR ≥ 300 mg/g AND eGFR ≥ 60 mL/min/1.73 m². * 3\. \*\*Heart Failure Status:\*\* * Clinical diagnosis of Heart Failure (NYHA Class II to IV) currently receiving inpatient or outpatient treatment. * Diagnosis must be confirmed by meeting at least 2 \*\*Major Criteria\*\* OR 1 \*\*Major Criterion\*\* plus 2 \*\*Minor Criteria\*\* (Framingham Criteria): * \*\*Major Criteria:\*\* Orthopnea or paroxysmal nocturnal dyspnea; Jugular venous distension; Hepatojugular reflux; Pulmonary rales; Third heart sound (S3) gallop; Pulmonary edema; Cardiomegaly. * \*\*Minor Criteria:\*\* Decreased exercise tolerance; Night cough; Dependent (ankle) edema; Tachycardia (heart rate \> 120 bpm); Hepatomegaly; Pleural effusion. * 4\. \*\*Left Ventricular Function:\*\* * Documented Left Ventricular Ejection Fraction (LVEF) ≥ 40% measured by transthoracic echocardiography within the last 12 months. * 5\. \*\*Structural Heart Disease:\*\* * Confirmed by echocardiography, meeting at least one of the fol…

What they're measuring

Change from baseline in Myocardial Extracellular Volume fraction (ECV)

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT07442448

SponsorCathay General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12