Finerenone and Cardiac Remodeling

NCT07270367 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CL-0011
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Heart Failure

Keywords

Finerenone; Left Ventricle Remodeling; Double-blind; Randomized; Heart Failure; Multicentre; Cardiorenal

Outcome Measures

Primary Outcomes (1)

• Left ventricular mass indexed to baseline body surface area (LVMi)

  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 Outcomes (7)

• Left Ventricular Ejection Fraction (LVEF)

  12 months

• Left Ventricular End-Diastolic Volume indexed to baseline body surface area (LVEDVi)

  12 months

• Left Ventricular End-Systolic Volume indexed to baseline body surface area (LVESVi)

  12 months

• Right Ventricular Ejection Fraction (RVEF)

  12 months

• Right Ventricular End-Diastolic Volume indexed to baseline body surface area (RVEDVi)

  12 months

Other Outcomes (9)

• Focal and Diffuse Fibrosis

  12 months

• Myocardial Strain Parameters - left ventricular global longitudinal strain

  12 months

• Myocardial Strain Parameters - global circumferential strain

  12 months

Study Arms (2)

Finerenone

ACTIVE COMPARATOR

Active treatment group

Drug: Finerenone

Placebo

PLACEBO COMPARATOR

Control treatment group

Drug: Placebo

Interventions

Finerenone DRUG

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

Also known as: Kerendia

Finerenone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Interventricular septal (IVS) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm
• Posterior wall (PW) thickness by echocardiography: Female ≥1.2 cm or Male ≥1.3 cm
• Left ventricular mass indexed to baseline body surface area (LVMi) by echocardiography: Female \>95 g⁄m\^2 or Male \>115 g⁄m\^2
• LVMi (with papillary muscles included in the LV blood pool) by cMRI: Female \>59 g⁄m\^2 or Male \>75 g⁄m\^2
• 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:
• History of heart failure with preserved ejection fraction (left ventricular ejection fraction \[LVEF\] ≥50%);
• Type 2 diabetes mellitus;
• Estimated glomerular filtration rate (eGFR) ≥25 and \<75 mL/min/1.73 m\^2;
• Urine albumin-creatinine ratio (UACR) \>3.39 mg/mmol and \<565 mg/mmol;
• 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);
• IVS ≥1.4 cm;
• PW ≥1.4 cm;

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Subodh Verma: lead
• Bayer: collaborator

Study Sites (3)

Cambride Cardiac Care Centre

Cambridge, Ontario, N1R6V6, Canada

Location

North York Diagnostic and Cardiac Centre

North York, Ontario, M6B3H7, Canada

Location

Diagnostic Assessment Centre

Toronto, Ontario, M1S4N6, Canada

Location

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Related Links

• American Heart Association Inc. Classes and Stages of Heart Failure. American Heart Association.

MeSH Terms

Conditions

Heart Failure; Ventricular Remodeling

Interventions

finerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Subodh Verma, MD, PhD

  North York Diagnostic and Cardiac Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subodh Verma, MD, PhD

CONTACT

416-864-5997; subodh.verma@nydcc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery and Pharmacology & Toxicology

Model Details: Prospective, double-blinded, randomized (1:1), placebo-controlled trial of finerenone vs placebo

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)