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Heart FailurePhase 4FIN-SGLT2-HFNCT07351864

Finerenone Plus SGLT2 Inhibitors in Heart Failure

A Phase 4 study testing Finerenone and dapagliflozine in people with Heart Failure, run by Mansoura University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical study is to evaluate whether adding finerenone to standard treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor provides additional benefits in patients with heart failure. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Heart Failure
What is being tested?
Finerenone and dapagliflozine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
18 Jan 2026to 31 Oct 2026
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients aged 18 - 65 years.
  • Newly diagnosed with HFrEF or HFpEF.
  • Clinically stable and eligible to start SGLT2 inhibitors ± Finerenone therapy.

Who cannot join

  • Patients with stroke.
  • eGFR <25 mL/min.
  • HF secondary to congenital heart disease or pulmonary hypertension
  • Use intravenous inotropes.
  • Patients needing cardiac transplantation.
  • Known allergy to study medications.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Mansoura University Hospitals, Cardiology Department (Specialized Medical Hospital)

    Al Mansurah

Other trials in Egypt

About this study

Official title: Impact of Finerenone in Combination With Sodium Glucose Cotransporter-2 Inhibitor in Patients With Heart Failure

The goal of this clinical study is to evaluate whether adding finerenone to standard treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor provides additional benefits in patients with heart failure.

The main question this study aims to answer is whether the combination of finerenone and an SGLT2 inhibitor improves clinical outcomes and is safe compared to treatment with an SGLT2 inhibitor alone.

Participants will receive standard therapy with an SGLT2 inhibitor, with or without the addition of finerenone and will be followed to assess clinical outcomes and safety.

Read the detailed description

Heart failure is a chronic clinical syndrome associated with significant morbidity, mortality and healthcare burden worldwide, despite advances in pharmacological therapy. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have become an important component of standard treatment for patients with heart failure due to their demonstrated cardiovascular benefits. However, a substantial residual cardiovascular risk persists, indicating the need for additional therapeutic strategies.

Finerenone is a nonsteroidal mineralocorticoid receptor antagonist with a distinct mechanism of action that targets mineralocorticoid receptor activation in cardiac and renal tissues. Previous clinical studies have demonstrated that finerenone reduces inflammation and fibrosis and provides cardiovascular benefits in patients with chronic cardiovascular and renal diseases. These findings support the potential for finerenone to offer complementary cardioprotective effects when combined with established heart failure therapies.

This prospective controlled pilot study is designed to evaluate the clinical effects and safety of adding finerenone to standard therapy with an SGLT2 inhibitor in patients with heart failure, compared with treatment using an SGLT2 inhibitor alone. Patients receiving stable SGLT2 inhibitor therapy will be managed according to the assigned treatment strategy and followed throughout the study period to evaluate overall clinical outcomes and safety parameters.

The findings of this pilot study are expected to provide preliminary evidence regarding the potential benefits and tolerability of combining finerenone with SGLT2 inhibitors in patients with heart failure and to inform the design of future larger-scale clinical studies.

Conditions
Heart Failure
Being tested
Finerenone, dapagliflozine
Keywords
Finerenone, SGLT2 inhibitor, Dapagliflozin, Heart failure therapy, Cardioprotection
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FinerenoneDrug

    Finerenone administered orally at a dose of 10 mg once daily.

  • dapagliflozineDrug

    Dapagliflozin administered orally at a dose of 10 mg once daily.

Study groups in NCT07351864
Study groupRoleWhat they receive
Finerenone Plus SGLT-2 inhibitor (dapagliflozin)ExperimentalParticipants in this arm will receive finerenone in addition to standard therapy with a sodium-glucose cotransporter-2 (SGLT2) inhibitor (dapagliflozin). Finerenone will be administered at a dose of 10 mg once daily and dapagliflozin will be administered at a dose of 10 mg once daily, according to standard clinical practice
Receives: Drug: Finerenone; Drug: dapagliflozine
SGLT-2 inhibitor (dapagliflozin) aloneActive comparatorParticipants in this arm will receive standard therapy with a sodium-glucose cotransporter-2 (SGLT2) inhibitor (dapagliflozin) alone. Dapagliflozin will be administered at a dose of 10 mg once daily according to standard clinical practice.
Receives: Drug: dapagliflozine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular Mortality and Heart Failure Hospitalization

    Incidence of cardiovascular mortality and hospitalization due to heart failure in each treatment group.

    Measured: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)

Secondary outcomes (5)

  1. All-cause Mortality

    Number of participants with all-cause mortality in each treatment group.

    Measured: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)

  2. Change in NYHA Functional Class

    Change in New York Heart Association (NYHA) functional class in each treatment group.

    Measured: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)

  3. Change in Serum Potassium Level

    Serum potassium concentration (mmol/L) measured at baseline, Week 4 and Week 12 in each treatment group.

    Measured: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)

  4. Change in Estimated Glomerular Filtration Rate (eGFR)

    Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) measured at baseline, Week 4 and Week 12 in each treatment group.

    Measured: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)

  5. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

    Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in each treatment group. Scores range from 0 to 100, with higher scores indicating better quality of life.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start18 Jan 2026
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07351864
Sponsor's protocol ID
MDP.25.08.190
Acronym
FIN-SGLT2-HF
Status last verified
Oct 2026
First submitted
28 Dec 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared outside the study team as the study is conducted for academic research purposes and data confidentiality will be maintained.

Publications

  • Filippatos G, Anker SD, Agarwal R, Ruilope LM, Rossing P, Bakris GL, Tasto C, Joseph A, Kolkhof P, Lage A, Pitt B; FIGARO-DKD Investigators. Finerenone Reduces Risk of Incident Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes: Analyses From the FIGARO-DKD Trial. Circulation. 2022 Feb 8;145(6):437-447. doi: 10.1161/CIRCULATIONAHA.121.057983. Epub 2021 Nov 13.

    PubMed 34775784

  • Pamporis K, Karakasis P, Sagris M, Zarifis I, Bougioukas KI, Pagkalidou E, Milaras N, Samaras A, Theofilis P, Fragakis N, Tousoulis D, Xanthos T, Giannakoulas G. Mineralocorticoid receptor antagonists in heart failure with reduced ejection fraction: a systematic review and network meta-analysis of 32 randomized trials. Curr Probl Cardiol. 2024 Jul;49(7):102615. doi: 10.1016/j.cpcardiol.2024.102615. Epub 2024 Apr 29.

    PubMed 38692445

  • Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

    PubMed 33264825

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Finerenone and dapagliflozine in people with Heart Failure, run by Mansoura University at 1 site in Egypt.

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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular Mortality and Heart Failure Hospitalization (time frame: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07351864, which also lists 3 linked publications.

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 9 Oct 2026.

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