NCT07442448

Brief 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. 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. 2.Does Finerenone improve global left ventricular longitudinal systolic strain (GLS) and other structural remodeling indices in this patient population?
  3. 3.Take Finerenone (Kerendia) 10 mg or 20 mg orally once daily for a total of 6 months.
  4. 4.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.
  5. 5.Receive regular clinical follow-up and blood tests to monitor safety (such as potassium levels and kidney function) and treatment efficacy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
43mo left

Started Apr 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2029

First Submitted

Initial submission to the registry

February 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Heart Failure and Preserved Ejection FractionHeart FailureHeart Failure and Mildly Reduced Ejection Fraction

Keywords

FinerenoneMyocardial fibrosisCardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Myocardial Extracellular Volume fraction (ECV)

    ECV is measured using Cardiac Magnetic Resonance (CMR) T1 mapping. It serves as a quantitative biomarker to evaluate the extent of diffuse myocardial fibrosis.

    Baseline and 6 months

Study Arms (1)

Finerenone Intervention Group

EXPERIMENTAL

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.

Drug: Finerenone

Interventions

FinerenoneDRUG

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.

Also known as: Kerendia, BAY 94-8862
Finerenone Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. \*\*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.
  • \. \*\*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.
  • \. \*\*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.
  • \. \*\*Left Ventricular Function:\*\*
  • Documented Left Ventricular Ejection Fraction (LVEF) ≥ 40% measured by transthoracic echocardiography within the last 12 months.
  • \. \*\*Structural Heart Disease:\*\*
  • +11 more criteria

You may not qualify if:

  • \. \*\*Renal and Electrolyte Stability:\*\*
  • eGFR \< 25 mL/min/1.73 m² (One re-evaluation is permitted prior to enrollment).
  • Serum potassium \> 5.0 mmol/L at any screening or enrollment visit (One re-evaluation is permitted prior to enrollment).
  • \. \*\*Recent Cardiovascular Events (within 90 days prior to enrollment):\*\*
  • Acute inflammatory heart disease (e.g., acute myocarditis).
  • Myocardial infarction or any event likely to reduce ejection fraction.
  • Coronary artery bypass graft (CABG) surgery or Percutaneous Coronary Intervention (PCI).
  • Stroke or Transient Ischemic Attack (TIA).
  • \. \*\*Comorbidities Mimicking Heart Failure:\*\*
  • Severe COPD requiring home oxygen therapy or chronic oral steroid therapy.
  • Primary pulmonary hypertension.
  • Hemoglobin \< 10 g/dL.
  • Clinically significant valvular heart disease.
  • Body Mass Index (BMI) \> 50 kg/m².
  • \. \*\*Hemodynamic and Rhythm Instability:\*\*
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cathay General Hospital

Taipei, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 25240451BACKGROUND

  • 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.

    PMID: 31696627BACKGROUND

  • 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.

    PMID: 39225278BACKGROUND

  • 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.

    PMID: 34449181BACKGROUND

  • 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.

    PMID: 33264825BACKGROUND

MeSH Terms

Conditions

Heart Failure, DiastolicHeart Failure

Interventions

finerenone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 2, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)