Heart FailurePhase 3FINE-MECHNCT07270367

Finerenone and Cardiac Remodeling

A Phase 3 study testing Finerenone in people with Heart Failure, run by Subodh Verma at 3 sites in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Finerenone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: 3 sitesCanada
Study dates: Dec 2025to Dec 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 18Show fewer

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;
LVMi ≥125 g⁄m^2 for males and ≥105 g⁄m^2 for females (by echocardiography);
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.
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.

Who cannot join

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;

Show all 30Show fewer

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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Subodh Verma, MD, PhD contact

416-864-5997

subodh.verma@nydcc.ca

Canada3 sites

Cambride Cardiac Care Centre
Cambridge, Ontario, N1R6V6
A Shekhar Pandey, MD, 519-624-3511, pandey@cambridgecardiaccare.com
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B3H7
Subodh Verma, MD, PhD, 416-783-0000, subodh.verma@nydcc.ca
Diagnostic Assessment Centre
Toronto, Ontario, M1S4N6
Verma Subodh, MD, PhD, 416-291-7300, subodh.verma@nydcc.ca

Other trials in Canada

About this study

Official title: 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

Read the 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.

Conditions: Heart Failure
Being tested: Finerenone, Placebo
Keywords: Finerenone, Left Ventricle Remodeling, Double-blind, Randomized, Heart Failure, Multicentre, Cardiorenal
Medical subject headings: Heart Failure, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FinerenoneDrug
Also called Kerendia
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
PlaceboDrug
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

Study groups in NCT07270367
Study group	Role	What they receive
Finerenone	Active comparator	Active treatment group Receives: Drug: Finerenone
Placebo	Placebo comparator	Control treatment group Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2025Dec 2030

First posted8 Dec 2025
Study startDec 2025 (estimated)
Primary completionDec 2030 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (45)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, double-blinded, randomized (1:1), placebo-controlled trial of finerenone vs placebo
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 156 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07270367
Sponsor's protocol ID: CL-0011
Acronym: FINE-MECH
Status last verified: Dec 2025
First submitted: 13 Nov 2025
Last updated: 8 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wang Y, Zhou R, Lu C, Chen Q, Xu T, Li D. Effects of the Angiotensin-Receptor Neprilysin Inhibitor on Cardiac Reverse Remodeling: Meta-Analysis. J Am Heart Assoc. 2019 Jul 2;8(13):e012272. doi: 10.1161/JAHA.119.012272. Epub 2019 Jun 26.
PubMed 31240976
Santos-Gallego CG, Vargas-Delgado AP, Requena-Ibanez JA, Garcia-Ropero A, Mancini D, Pinney S, Macaluso F, Sartori S, Roque M, Sabatel-Perez F, Rodriguez-Cordero A, Zafar MU, Fergus I, Atallah-Lajam F, Contreras JP, Varley C, Moreno PR, Abascal VM, Lala A, Tamler R, Sanz J, Fuster V, Badimon JJ; EMPA-TROPISM (ATRU-4) Investigators. Randomized Trial of Empagliflozin in Nondiabetic Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2021 Jan 26;77(3):243-255. doi: 10.1016/j.jacc.2020.11.008. Epub 2020 Nov 13.
PubMed 33197559
Kasama S, Toyama T, Sumino H, Matsumoto N, Sato Y, Kumakura H, Takayama Y, Ichikawa S, Suzuki T, Kurabayashi M. Additive effects of spironolactone and candesartan on cardiac sympathetic nerve activity and left ventricular remodeling in patients with congestive heart failure. J Nucl Med. 2007 Dec;48(12):1993-2000. doi: 10.2967/jnumed.107.045427. Epub 2007 Nov 15.
PubMed 18006623
Dorr K, Kammerlander A, Lauriero F, Lorenz M, Marculescu R, Beitzke D. Effect of etelcalcetide versus alfacalcidol on left ventricular function and feature-tracking cardiac magnetic resonance imaging in hemodialysis-a post-hoc analysis of a randomized, controlled trial. J Cardiovasc Magn Reson. 2023 Nov 6;25(1):62. doi: 10.1186/s12968-023-00975-4.
PubMed 37932788
Everett RJ, Tastet L, Clavel MA, Chin CWL, Capoulade R, Vassiliou VS, Kwiecinski J, Gomez M, van Beek EJR, White AC, Prasad SK, Larose E, Tuck C, Semple S, Newby DE, Pibarot P, Dweck MR. Progression of Hypertrophy and Myocardial Fibrosis in Aortic Stenosis: A Multicenter Cardiac Magnetic Resonance Study. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007451. doi: 10.1161/CIRCIMAGING.117.007451.
PubMed 29914867
Biederman RW, Magovern JA, Grant SB, Williams RB, Yamrozik JA, Vido DA, Rathi VK, Rayarao G, Caruppannan K, Doyle M. LV reverse remodeling imparted by aortic valve replacement for severe aortic stenosis; is it durable? A cardiovascular MRI study sponsored by the American Heart Association. J Cardiothorac Surg. 2011 Apr 14;6:53. doi: 10.1186/1749-8090-6-53.
PubMed 21492429
Cicoira M, Zanolla L, Rossi A, Golia G, Franceschini L, Brighetti G, Marino P, Zardini P. Long-term, dose-dependent effects of spironolactone on left ventricular function and exercise tolerance in patients with chronic heart failure. J Am Coll Cardiol. 2002 Jul 17;40(2):304-10. doi: 10.1016/s0735-1097(02)01965-4.
PubMed 12106936
Kosmala W, Przewlocka-Kosmala M, Szczepanik-Osadnik H, Mysiak A, Marwick TH. Fibrosis and cardiac function in obesity: a randomised controlled trial of aldosterone blockade. Heart. 2013 Mar;99(5):320-6. doi: 10.1136/heartjnl-2012-303329. Epub 2013 Jan 23.
PubMed 23343682
Chan AK, Sanderson JE, Wang T, Lam W, Yip G, Wang M, Lam YY, Zhang Y, Yeung L, Wu EB, Chan WW, Wong JT, So N, Yu CM. Aldosterone receptor antagonism induces reverse remodeling when added to angiotensin receptor blockade in chronic heart failure. J Am Coll Cardiol. 2007 Aug 14;50(7):591-6. doi: 10.1016/j.jacc.2007.03.062. Epub 2007 Jul 30.
PubMed 17692742
Vizzardi E, D'Aloia A, Giubbini R, Bordonali T, Bugatti S, Pezzali N, Romeo A, Dei Cas A, Metra M, Dei Cas L. Effect of spironolactone on left ventricular ejection fraction and volumes in patients with class I or II heart failure. Am J Cardiol. 2010 Nov 1;106(9):1292-6. doi: 10.1016/j.amjcard.2010.06.052. Epub 2010 Sep 9.
PubMed 21029826
Verma S, Mazer CD, Yan AT, Mason T, Garg V, Teoh H, Zuo F, Quan A, Farkouh ME, Fitchett DH, Goodman SG, Goldenberg RM, Al-Omran M, Gilbert RE, Bhatt DL, Leiter LA, Juni P, Zinman B, Connelly KA. Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial. Circulation. 2019 Nov 19;140(21):1693-1702. doi: 10.1161/CIRCULATIONAHA.119.042375. Epub 2019 Aug 22.
PubMed 31434508
Zhou D, Huang Y, Cai A, Yan M, Cheng Q, Feng X, Nie Z, Feng Y. Longitudinal Study of Left Ventricular Mass Index Trajectories and Risk of Mortality in Hypertension: A Cohort Study. J Am Heart Assoc. 2023 May 2;12(9):e028568. doi: 10.1161/JAHA.122.028568. Epub 2023 Apr 29.
PubMed 37119065
Verma A, Meris A, Skali H, Ghali JK, Arnold JM, Bourgoun M, Velazquez EJ, McMurray JJ, Kober L, Pfeffer MA, Califf RM, Solomon SD. Prognostic implications of left ventricular mass and geometry following myocardial infarction: the VALIANT (VALsartan In Acute myocardial iNfarcTion) Echocardiographic Study. JACC Cardiovasc Imaging. 2008 Sep;1(5):582-91. doi: 10.1016/j.jcmg.2008.05.012.
PubMed 19356485
Rosch S, Kresoja KP, Besler C, Fengler K, Schober AR, von Roeder M, Lucke C, Gutberlet M, Klingel K, Thiele H, Rommel KP, Lurz P. Characteristics of Heart Failure With Preserved Ejection Fraction Across the Range of Left Ventricular Ejection Fraction. Circulation. 2022 Aug 16;146(7):506-518. doi: 10.1161/CIRCULATIONAHA.122.059280. Epub 2022 Jul 8.
PubMed 35862208
Playford D, Strange G, Joseph M, Perry R, Chan YK, Strom JB, Spetko N, Harris SA, Stewart S, Selvanayagam JB. Increasing Left Ventricular Mass and Death in Men and Women Investigated With Echocardiography. J Am Heart Assoc. 2025 Dec 16;14(24):e041927. doi: 10.1161/JAHA.125.041927. Epub 2025 Dec 11.
PubMed 41378460

Interested in taking part?

Subodh Verma, MD, PhD

416-864-5997

subodh.verma@nydcc.ca

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Finerenone and Cardiac Remodeling: A Randomized, Double- Blind, Placebo-Controlled Study to Evaluate The Effects of Finerenone on Ventricular Remodeling
ClinicalTrials.gov ID: NCT07270367
Acronym / sponsor ID: FINE-MECH / CL-0011
Conditions: Heart Failure
Keywords: Finerenone, Left Ventricle Remodeling, Double-blind, Randomized, Heart Failure, Multicentre, Cardiorenal
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 156 participants (estimated)
Lead sponsor: Subodh VermaUniversity, hospital or other
Collaborators: Bayer
Study start: Dec 2025 (estimated)
Primary completion: Dec 2030 (estimated)
Study completion: Dec 2030 (estimated)
First posted: 8 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Prospective, double-blinded, randomized (1:1), placebo-controlled trial of finerenone vs placebo

Arm	Type	Receives
Finerenone	Active comparator	Drug: FinerenoneActive treatment group
Placebo	Placebo comparator	Drug: PlaceboControl treatment group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (30 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FinerenoneAlso: KerendiaParticipants 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	Drug	Finerenone
PlaceboParticipants 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	Drug	Placebo

Primary outcome

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.

7 secondary outcomes

Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 months
Left Ventricular End-Diastolic Volume indexed to baseline body surface area (LVEDVi)
Time frame: 12 months
Left Ventricular End-Systolic Volume indexed to baseline body surface area (LVESVi)
Time frame: 12 months
Right Ventricular Ejection Fraction (RVEF)
Time frame: 12 months
Right Ventricular End-Diastolic Volume indexed to baseline body surface area (RVEDVi)
Time frame: 12 months
Right Ventricular End-Systolic Volume indexed to baseline body surface area (RVESVi)
Time frame: 12 months
Left Atrial Volume indexed to baseline body surface area (LAVi)
Time frame: 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
Background: PubMed 31240976Wang Y, Zhou R, Lu C, Chen Q, Xu T, Li D. Effects of the Angiotensin-Receptor Neprilysin Inhibitor on Cardiac Reverse Remodeling: Meta-Analysis. J Am Heart Assoc. 2019 Jul 2;8(13):e012272. doi: 10.1161/JAHA.119.012272. Epub 2019 Jun 26.
Background: PubMed 33197559Santos-Gallego CG, Vargas-Delgado AP, Requena-Ibanez JA, Garcia-Ropero A, Mancini D, Pinney S, Macaluso F, Sartori S, Roque M, Sabatel-Perez F, Rodriguez-Cordero A, Zafar MU, Fergus I, Atallah-Lajam F, Contreras JP, Varley C, Moreno PR, Abascal VM, Lala A, Tamler R, Sanz J, Fuster V, Badimon JJ; EMPA-TROPISM (ATRU-4) Investigators. Randomized Trial of Empagliflozin in Nondiabetic Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2021 Jan 26;77(3):243-255. doi: 10.1016/j.jacc.2020.11.008. Epub 2020 Nov 13.
Background: PubMed 18006623Kasama S, Toyama T, Sumino H, Matsumoto N, Sato Y, Kumakura H, Takayama Y, Ichikawa S, Suzuki T, Kurabayashi M. Additive effects of spironolactone and candesartan on cardiac sympathetic nerve activity and left ventricular remodeling in patients with congestive heart failure. J Nucl Med. 2007 Dec;48(12):1993-2000. doi: 10.2967/jnumed.107.045427. Epub 2007 Nov 15.
Background: PubMed 37932788Dorr K, Kammerlander A, Lauriero F, Lorenz M, Marculescu R, Beitzke D. Effect of etelcalcetide versus alfacalcidol on left ventricular function and feature-tracking cardiac magnetic resonance imaging in hemodialysis-a post-hoc analysis of a randomized, controlled trial. J Cardiovasc Magn Reson. 2023 Nov 6;25(1):62. doi: 10.1186/s12968-023-00975-4.
Background: PubMed 29914867Everett RJ, Tastet L, Clavel MA, Chin CWL, Capoulade R, Vassiliou VS, Kwiecinski J, Gomez M, van Beek EJR, White AC, Prasad SK, Larose E, Tuck C, Semple S, Newby DE, Pibarot P, Dweck MR. Progression of Hypertrophy and Myocardial Fibrosis in Aortic Stenosis: A Multicenter Cardiac Magnetic Resonance Study. Circ Cardiovasc Imaging. 2018 Jun;11(6):e007451. doi: 10.1161/CIRCIMAGING.117.007451.
Background: PubMed 21492429Biederman RW, Magovern JA, Grant SB, Williams RB, Yamrozik JA, Vido DA, Rathi VK, Rayarao G, Caruppannan K, Doyle M. LV reverse remodeling imparted by aortic valve replacement for severe aortic stenosis; is it durable? A cardiovascular MRI study sponsored by the American Heart Association. J Cardiothorac Surg. 2011 Apr 14;6:53. doi: 10.1186/1749-8090-6-53.
Background: PubMed 12106936Cicoira M, Zanolla L, Rossi A, Golia G, Franceschini L, Brighetti G, Marino P, Zardini P. Long-term, dose-dependent effects of spironolactone on left ventricular function and exercise tolerance in patients with chronic heart failure. J Am Coll Cardiol. 2002 Jul 17;40(2):304-10. doi: 10.1016/s0735-1097(02)01965-4.
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American Heart Association Inc. Classes and Stages of Heart Failure. American Heart Association.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Subodh Verma, MD, PhD contact

416-864-5997

subodh.verma@nydcc.ca

Subodh Verma, MD, PhD principal investigator

North York Diagnostic and Cardiac Centre

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Finerenone in people with Heart Failure, run by Subodh Verma at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Subodh Verma, MD, PhD (416-864-5997, subodh.verma@nydcc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular mass indexed to baseline body surface area (LVMi) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07270367, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.