Finerenone and Cardiac Remodeling (FINE-MECH)

December 5, 2025 updated by: Subodh Verma

Finerenone and Cardiac Remodeling: A Randomized, Double- Blind, Placebo-Controlled Study to Evaluate The Effects of Finerenone on Ventricular Remodeling

The goal of this clinical trial is to learn if the drug finerenone (Karendia) can improve heart function in participants who are at risk for heart and kidney disease.

The main question it aims to answer is whether adding finerenone to standard-of-care heart failure medical therapies will beneficially alter the heart structure and function of people who have risk factors for heart and kidney complications and whose left side of the heart is enlarged.

The researchers will compare finerenone to a placebo (a look-alike substance that contains no drug) to see if finerenone improves heart structure and function.

Participants will:

  • take a finerenone or a placebo tablet once a day for 12 months
  • have a cardiac magnetic resonance imaging (cMRI; a safe, non-invasive scan to measure heart mass, stiffness and function) test at the beginning of the study and 12 months later
  • visit the clinic after one, three, six and twelve months to assess overall health and/or perform blood or urine tests

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Finerenone is a potent and selective oral non-steroidal mineralocorticoid receptor antagonist that has demonstrated marked cardiovascular benefits in people living with diabetic kidney disease, heart failure with mildly reduced ejection fraction, and heart failure with preserved ejection fraction. However, the mechanistic basis of these broad cardiovascular benefits remains unclear.

The FINE-MECH CardioLink-11 trial is a multicentre, prospective, randomized, double-blind trial of finerenone vs placebo in addition to standard-of-care in adults with evidence of left ventricular hypertrophy and cardiorenal risk factors. A total of 156 individuals who provide written informed consent and meet all the inclusion criteria (and none of the exclusion criteria) will be assigned (1:1) to receive either finerenone or placebo QD for 12 months. There will be 6-7 clinic visits. Outcome assessors will be blinded to the investigational product allocation and the time point at which each assessment was completed.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N1R6V6
      • North York, Ontario, Canada, M6B3H7
        • North York Diagnostic and Cardiac Centre
        • Contact:
      • Toronto, Ontario, Canada, M1S4N6
        • Diagnostic Assessment Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals ≥18 years of age who are willing and able to provide signed informed consent

  • Evidence of left ventricular (LV) hypertrophy ≤12 months prior to or at screening showing at least one (≥1) of the following:

    1. Interventricular septal (IVS) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm
    2. Posterior wall (PW) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm
    3. Left ventricular mass indexed to baseline body surface area (LVMi) by echocardiography: Female >95 g⁄m^2 or Male >115 g⁄m^2
    4. LVMi (with papillary muscles included in the LV blood pool) by cMRI: Female >59 g⁄m^2 or Male >75 g⁄m^2
    5. LVMi (if the papillary muscles are included in the LVM) by cMRI: Female >68 g⁄m^2 or Male >85 g⁄m^2

  • The presence of at least one (≥1) of the following risk factors:

    1. History of heart failure with preserved ejection fraction (left ventricular ejection fraction [LVEF] ≥50%);
    2. Type 2 diabetes mellitus;
    3. Estimated glomerular filtration rate (eGFR) ≥25 and <75 mL/min/1.73 m^2;
    4. Urine albumin-creatinine ratio (UACR) >3.39 mg/mmol and <565 mg/mmol;
    5. Left atrial volume indexed to baseline body surface area (LAVi) >40 mL/m^2 (by echocardiography and as measured by either the biplane area-length method or Simpson's biplane method);
    6. IVS ≥1.4 cm;
    7. PW ≥1.4 cm;
    8. LVMi ≥125 g⁄m^2 for males and ≥105 g⁄m^2 for females (by echocardiography);
    9. N-terminal pro-B-type natriuretic peptide (NT-proBNP; within past 6 months) ≥150 pg/mL if in sinus rhythm or ≥450 pg/mL if atrial fibrillation is present.
    10. Females who are of childbearing age can only be included if I. they are postmenopausal (i.e. no menstruation for at least one [≥1] year) or have had a surgical procedure ≥6 months at screening that prevents them from becoming pregnant; or II. the result of their pregnancy test at the baseline visit is negative, and they agree to use medically acceptable contraception methods to avoid pregnancy for the duration of the trial and for 1 month after taking the last dose of the assigned investigational product.

Exclusion Criteria:

  • Females who are planning to become pregnant, are breastfeeding or are planning to breastfeed;
  • Males who are planning to either father a child or donate sperm for the duration of the trial and for 1 month after taking the last dose of the assigned IP;
  • Serum potassium level ≥5 mmol/L at the time of screening;
  • eGFR <25 mL/min/1.73 m^2 at the time of screening or on kidney replacement therapy;
  • UACR ≥565 mg/mmol at the time of screening;
  • Seated systolic blood pressure <110 mmHg at the time of screening;
  • History of pulmonary arterial hypertension;
  • Type 1 diabetes mellitus;
  • Body mass index ≥40 kg/m^2;
  • Contraindication or inability to undergo MRI;
  • Known persistent hypoalbuminemia (≤30 g/L on >1 measurement within last 6 months);
  • Currently on a mineralocorticoid receptor antagonist (MRA) or in the opinion of the investigator, an MRA is either clinically indicated or contraindicated (e.g. history of marked hyperkalemia, marked hemodynamic stress, intolerance to MRAs) - individuals who previously experienced gynecomastia with spironolactone may be eligible if they meet all the inclusion criteria and none of the exclusion criteria;
  • Requirement of any intravenous (IV) vasodilating drug (e.g. nitrates, nitroprusside), any IV natriuretic peptide (e.g. nesiritide, carperitide), any IV positive inotropic agents, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) ≤24 hours prior to randomization;
  • Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin) or moderate or potent CYP3A4 inducers, that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period;
  • History of cardiac device implant (e.g. implantable cardioverter defibrillator/cardiac resynchronization therapy/pacemaker) or planned device implant ≤90 days after screening;
  • Hospitalized for heart failure (HF) requiring initiation or change in HF therapy or an urgent visit for HF requiring IV diuretic therapy, either ≤45 days prior to screening;
  • LVEF <40% per the most current echocardiogram or MRI;
  • Symptomatic bradycardia or second- or third-degree heart block without a pacemaker;
  • History of peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, right HF in the absence of left-sided structural disease, pericardial constriction, hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloidosis;
  • Myocardial infarction ≤45 days of screening;
  • Planned or previous cardiac surgery or major non-cardiac surgery ≤45 days of screening;
  • Planned or previous percutaneous coronary intervention ≤45 days of screening;
  • Stroke or transient ischemic stroke ≤90 days before randomization;
  • Severe valvular heart disease;
  • Addison's disease;
  • Individuals who are heart or kidney transplant recipients or who are (or are expected to be) listed for heart transplant, kidney dialysis or a kidney transplant ≤12 months of screening;
  • Any other known condition or therapy which would make the individual unsuitable for this trial (e.g. hepatic insufficiency, liver biomarkers >3X upper limit of normal, chronic pulmonary disease, life threatening arrhythmia, uncontrolled arrhythmia) or not allow participation for the full planned trial duration (e.g. active malignancy ≤24 months of screening or condition limiting life expectancy to <12 months);
  • Allergy to finerenone (or its excipients);
  • Allergy to gadolinium;
  • Participation in an investigational study ≤15 days prior to screening, or during study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Finerenone
Active treatment group
Drug: Finerenone
Participants will be allocated a starting dose of 10 or 20 mg of finerenone (dependent on kidney function) once daily, in addition to standard-of-care. Participants may be up-titrated or down-titrated based on potassium levels or estimated glomerular filtration rate with a minimum dose of 10 mg and maximum dose of 40 mg finerenone
Other Names:
  • Kerendia
Placebo Comparator: Placebo
Control treatment group
Drug: Placebo
Participants will be allocated a starting dose of 10 or 20 mg of placebo (dependent on kidney function) once daily, in addition to standard-of-care. Participants may be up-titrated or down-titrated based on potassium levels or estimated glomerular filtration rate with a minimum dose of 10 mg and maximum dose of 40 mg placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular mass indexed to baseline body surface area (LVMi)
Time Frame: 12 months
Change in LVMi (g/m^2), measured by cardiac magnetic resonance imaging (cMRI) from baseline to 12 months of treatment with finerenone compared to placebo. cMRI evaluations will be made from standard 2D views with and without gadolinium as a contrast agent. All acquired sequences will adhere to the current clinical standard of care.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular Ejection Fraction (LVEF)
Time Frame: 12 months
Change in LVEF, measured by cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Left Ventricular End-Diastolic Volume indexed to baseline body surface area (LVEDVi)
Time Frame: 12 months
Change in LVEDVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Left Ventricular End-Systolic Volume indexed to baseline body surface area (LVESVi)
Time Frame: 12 months
Change in LVESVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Right Ventricular Ejection Fraction (RVEF)
Time Frame: 12 months
Change in RVEF, measured by cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Right Ventricular End-Diastolic Volume indexed to baseline body surface area (RVEDVi)
Time Frame: 12 months
Change in RVEDVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Right Ventricular End-Systolic Volume indexed to baseline body surface area (RVESVi)
Time Frame: 12 months
Change in RVESVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Left Atrial Volume indexed to baseline body surface area (LAVi)
Time Frame: 12 months
Change in LAVi, measured by cMRI and indexed to baseline body surface area, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focal and Diffuse Fibrosis
Time Frame: 12 months
Effect on focal fibrosis (assessed by late gadolinium enhancement and diffuse fibrosis (assessed by extracellular volume using T1 mapping) measured by cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Myocardial Strain Parameters - left ventricular global longitudinal strain
Time Frame: 12 months
Effect on left ventricular global longitudinal strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Myocardial Strain Parameters - global circumferential strain
Time Frame: 12 months
Effect on global circumferential strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Myocardial Strain Parameters - global radial strain
Time Frame: 12 months
Effect on global radial strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Myocardial Strain Parameters - diastolic strain rate
Time Frame: 12 months
Effect on diastolic strain rate, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Myocardial Strain Parameters - right ventricular free wall strain
Time Frame: 12 months
Effect on right ventricular free wall strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Myocardial Strain Parameters - left atrial strain
Time Frame: 12 months
Effect on left atrial strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
Myocardial Strain Parameters - right atrial strain
Time Frame: 12 months
Effect on right atrial strain, assessed by speckle tracking echocardiography and/or feature-tracking cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
12 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP) Levels
Time Frame: 12 months
Change in NT-proBNP concentration from baseline to 12 months of treatment with finerenone compared to placebo.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Subodh Verma

Collaborators

Bayer

Investigators

  • Principal Investigator: Subodh Verma, MD, PhD, North York Diagnostic and Cardiac Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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