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
Qualifiers
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
Treatments tested in this trial
- Finerenone
- Placebo
Treatment groups
156 Participants
are divided into 2 treatment groupsSponsors and collaborators
Subodh Verma
Lead sponsor
Canadian Medical and Surgical Knowledge Translation Research Group
Sponsor institution
Bayer
Collaborator
Source ClinicalTrials.gov