A Phase 3 interventional study of Finerenone and Placebo in Heart Failure, sponsored by Subodh Verma. Not yet recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Subodh Verma · Phase 3, Interventional, and Treatment
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:
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 156 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Subodh Verma is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active treatment group
Drug: Finerenone
Control treatment group
Drug: Placebo
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
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
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.
Time frame: 12 months
Left Ventricular Ejection Fraction (LVEF)
Change in LVEF, measured by cMRI, from baseline to 12 months of treatment with finerenone compared to placebo.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Focal and Diffuse Fibrosis
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.
Time frame: 12 months
Myocardial Strain Parameters - left ventricular global longitudinal strain
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.
Time frame: 12 months
Myocardial Strain Parameters - global circumferential strain
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.
Time frame: 12 months
Myocardial Strain Parameters - global radial strain
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.
Time frame: 12 months
Myocardial Strain Parameters - diastolic strain rate
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.
Time frame: 12 months
Myocardial Strain Parameters - right ventricular free wall strain
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.
Time frame: 12 months
Myocardial Strain Parameters - left atrial strain
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.
Time frame: 12 months
Myocardial Strain Parameters - right atrial strain
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.
Time frame: 12 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP) Levels
Change in NT-proBNP concentration from baseline to 12 months of treatment with finerenone compared to placebo.
Time frame: 12 months
Plan to share: No
Start is estimated for Dec 2025; primary completion for Dec 2030, 60 months later.
Of 88 non-industry phase 3 interventional studies under Heart Failure, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 63. This study's planned 60 months is above that.
Counting every sponsor, half of 151 studies reached it within 39 months; a quarter within 25 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Finerenone
Subodh Verma