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 range

18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Heart Failure and Preserved Ejection Fraction trials