Finerenone and Cardiac Remodeling
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSubodh Verma
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals ≥18 years of age who are willing and able to provide signed informed consent
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⁄m² or Male >115 g⁄m²
Disqualifiers
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 m² at the time of screening or on kidney replacement therapy;
Trial design
Design model
Parallel
Treatments tested in this trial
Finerenone
DrugParticipants 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
Placebo
DrugParticipants 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
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: FinerenoneActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsOther outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Subodh Verma
Lead sponsor
Canadian Medical and Surgical Knowledge Translation Research Group
Sponsor institution
Bayer
Collaborator
Source ClinicalTrials.gov
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