This prospective randomized study aims to evaluate the efficacy of Finerenone as add-on therapy to standard of care compared to standard of care alone in preventing heart failure worsening and preserving cardiac function assessed by left ventricular strain in patients with heart failure with preserved ejection fraction.
Overactivation of the mineralocorticoid receptor drives inflammation fibrosis and heart failure progression. Left ventricular global longitudinal strain measured by speckle tracking echocardiography is a sensitive marker for early myocardial remodeling. This is a prospective randomized parallel assignment study. Patients with HFpEF defined by HFA-PEFF score will be randomized to Finerenone plus standard of care or standard of care alone and followed for 6 months with clinical laboratory ECG and echocardiography assessment including speckle tracking at baseline and 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
Non-steroidal mineralocorticoid receptor antagonist 10 to 20 mg orally once daily for 6 months with monitoring of potassium creatinine and eGFR
Standard of care for heart failure with preserved ejection fraction according to 2022 AHA ACC HFSA guideline including diuretics and guideline-directed medical therapy without Finerenone
Change in left ventricular global longitudinal strain
Absolute change in left ventricular global longitudinal strain measured by speckle tracking echocardiography using QLAB 10.4 software from apical four-chamber views with three consecutive heart cycles greater than 61 frames per second. More negative values indicate better function
Time frame: From baseline to 6 months
Change in left ventricular reservoir strain
Absolute change in left ventricular reservoir strain measured by speckle tracking echocardiography from baseline to 6 months
Time frame: From baseline to 6 months
Number of participants with heart failure hospitalization
Number of participants who experience heart failure hospitalization
Time frame: Up to 6 months
Number of participants with major adverse cardiovascular events
Number of participants with non-fatal myocardial infarction or ischemic stroke
Time frame: Up to 6 months
Change in NT-proBNP level
Change in N-terminal pro B-type natriuretic peptide level in picograms per milliliter
Time frame: From baseline to 6 months
Change in NYHA functional class
Change in New York Heart Association functional class score range 1 to 4 with higher scores indicating worse symptoms
Time frame: From baseline to 6 months
Number of participants with dyspnea worsening
Number of participants with worsening of dyspnea assessed by five-point Likert scale score range 1 to 5 with higher scores indicating worse dyspnea
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Time frame: Up to 6 months
Number of participants with diuretic dose escalation
Number of participants who require diuretic dose escalation during the 6-month follow-up
Time frame: Up to 6 months
Number of participants with hyperkalemia
Number of participants who develop hyperkalemia defined as serum potassium greater than 5.5 milliequivalents per liter
Time frame: Up to 6 months
Number of participants with acute kidney injury
Number of participants who develop acute kidney injury defined as increase in serum creatinine greater than 0.3 milligrams per deciliter
Time frame: Up to 6 months