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NCT Number: NCT07830940

Finerenone and Cardiac Remodeling in HFpEF

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 18 years
  • Clinically evidenced heart failure with left ventricular ejection fraction greater than or equal to 50 percent
  • HFA-PEFF score greater than or equal to 5 or score 2 to 4 with functional testing confirming HFpEF
  • Sinus rhythm on resting ECG at screening
  • Written informed consent

Exclusion criteria

  • Implanted cardiac pacemaker or defibrillator with active atrial pacing
  • Estimated glomerular filtration rate less than 25 milliliters per minute per 1.73 square meters
  • Baseline serum potassium greater than 5 milliequivalents per liter
  • Known hypersensitivity to Finerenone

Treatment and study plan

Finerenone

Drug

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 HFpEF Description:

Other

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

Primary outcomes

  1. Change in left ventricular global longitudinal strain

    Time frame: From baseline to 6 months

    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

Secondary outcomes

  1. Change in left ventricular reservoir strain

    Time frame: From baseline to 6 months

    Absolute change in left ventricular reservoir strain measured by speckle tracking echocardiography from baseline to 6 months

  2. Number of participants with heart failure hospitalization

    Time frame: Up to 6 months

    Number of participants who experience heart failure hospitalization

  3. Number of participants with major adverse cardiovascular events

    Time frame: Up to 6 months

    Number of participants with non-fatal myocardial infarction or ischemic stroke

  4. Change in NT-proBNP level

    Time frame: From baseline to 6 months

    Change in N-terminal pro B-type natriuretic peptide level in picograms per milliliter

  5. Change in NYHA functional class

    Time frame: From baseline to 6 months

    Change in New York Heart Association functional class score range 1 to 4 with higher scores indicating worse symptoms

  6. Number of participants with dyspnea worsening

    Time frame: Up to 6 months

    Number of participants with worsening of dyspnea assessed by five-point Likert scale score range 1 to 5 with higher scores indicating worse dyspnea

  7. Number of participants with diuretic dose escalation

    Time frame: Up to 6 months

    Number of participants who require diuretic dose escalation during the 6-month follow-up

  8. Number of participants with hyperkalemia

    Time frame: Up to 6 months

    Number of participants who develop hyperkalemia defined as serum potassium greater than 5.5 milliequivalents per liter

  9. Number of participants with acute kidney injury

    Time frame: Up to 6 months

    Number of participants who develop acute kidney injury defined as increase in serum creatinine greater than 0.3 milligrams per deciliter

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Impact of Finerenone on Cardiac Remodeling and Heart Failure Progression in Patients With Heart Failure With Preserved Ejection Fraction The FIN-HF-LVS Registry

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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