Finerenone and Cardiac Remodeling in HFpEF

NCT07830940 | Not Yet Recruiting Phase 4

• 1 other identifier: FIN-HF-LVS-Assiut-26
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Cardiac remodeling; Finerenone; HFpEF; Global longitudinal strain; Speckle tracking

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline to 6 months

Secondary Outcomes (9)

• Change in left ventricular reservoir strain

  From baseline to 6 months

• Number of participants with heart failure hospitalization

  Up to 6 months

• Number of participants with major adverse cardiovascular events

  Up to 6 months

• Change in NT-proBNP level

  From baseline to 6 months

• Change in NYHA functional class

  From baseline to 6 months

Study Arms (2)

Finerenone plus Standard of Care

EXPERIMENTAL

Finerenone 10 mg once daily titrated to 20 mg once daily based on serum potassium and eGFR plus standard of care for HFpEF for 6 months

Drug: Finerenone; Other: Standard of care for HFpEF Description:

Standard of Care alone

ACTIVE COMPARATOR

Standard of care for HFpEF according to 2022 AHA ACC HFSA guideline without Finerenone

Other: Standard of care for HFpEF Description:

Interventions

Finerenone DRUG

Non-steroidal mineralocorticoid receptor antagonist 10 to 20 mg orally once daily for 6 months with monitoring of potassium creatinine and eGFR

Finerenone plus Standard of Care

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

Finerenone plus Standard of Care; Standard of Care alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

finerenone; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ahmed A Ahmed, prof

  Cardiovascular Medicine Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Mostafa M Khairy, Resident

CONTACT

01145340851; Mostfa.elfraa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of cardiovascular

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): September 25, 2027
• Study Completion (Estimated): March 25, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09