Heart Failure With Preserved Ejection FractionPhase 4NCT07830940
Finerenone and Cardiac Remodeling in HFpEF
A Phase 4 study testing Finerenone in people with Heart Failure With Preserved Ejection Fraction, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 25 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Finerenone, Standard of care for HFpEF Description:
- Keywords
- Cardiac remodeling, Finerenone, HFpEF, Global longitudinal strain, Speckle tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Standard of care for HFpEF Description: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 6 months
Secondary outcomes (9)
Change in left ventricular reservoir strain
Absolute change in left ventricular reservoir strain measured by speckle tracking echocardiography from baseline to 6 months
Measured: From baseline to 6 months
Number of participants with heart failure hospitalization
Number of participants who experience heart failure hospitalization
Measured: Up to 6 months
Number of participants with major adverse cardiovascular events
Number of participants with non-fatal myocardial infarction or ischemic stroke
Measured: Up to 6 months
Change in NT-proBNP level
Change in N-terminal pro B-type natriuretic peptide level in picograms per milliliter
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Khairy, Assiut University
- Investigators
- Ahmed A Ahmed, prof, Study chair, Cardiovascular Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830940
- Sponsor's protocol ID
- FIN-HF-LVS-Assiut-26
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07830940
- Acronym / sponsor ID
- FIN-HF-LVS-Assiut-26
- Keywords
- Cardiac remodeling, Finerenone, HFpEF, Global longitudinal strain, Speckle tracking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone plus Standard of Care | Experimental | Drug: Finerenone, Other: Standard of care for HFpEF Description: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 |
| Standard of Care alone | Active comparator | Other: Standard of care for HFpEF Description:Standard of care for HFpEF according to 2022 AHA ACC HFSA guideline without Finerenone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneNon-steroidal mineralocorticoid receptor antagonist 10 to 20 mg orally once daily for 6 months with monitoring of potassium creatinine and eGFR | Drug | Finerenone plus Standard of Care |
| Standard of care for HFpEF Description: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 | Other | Finerenone plus Standard of Care, Standard of Care alone |
Primary outcome
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
9 secondary outcomes
Change in left ventricular reservoir strain
Time frame: From baseline to 6 months
Number of participants with heart failure hospitalization
Time frame: Up to 6 months
Number of participants with major adverse cardiovascular events
Time frame: Up to 6 months
Change in NT-proBNP level
Time frame: From baseline to 6 months
Change in NYHA functional class
Time frame: From baseline to 6 months
Number of participants with dyspnea worsening
Time frame: Up to 6 months
Number of participants with diuretic dose escalation
Time frame: Up to 6 months
Number of participants with hyperkalemia
Time frame: Up to 6 months
Number of participants with acute kidney injury
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed A Ahmed, prof study chair
Cardiovascular Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone in people with Heart Failure With Preserved Ejection Fraction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa M Khairy, Resident (01145340851, Mostfa.elfraa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular global longitudinal strain (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.