Finerenone Plus SGLT2 Inhibitors in Heart Failure (FIN-SGLT2-HF)

January 11, 2026 updated by: Mansour Saad, Mansoura University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mansour Saad Alqahtani, PhD Candidate
  • Phone Number: +966554433848
  • Email: mushyt2003@gmail.com

Study Contact Backup

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Mansoura University Hospitals, Cardiology Department (Specialized Medical Hospital)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mansour Saad Alqahtani, Phd Candidate
        • Sub-Investigator:
          • Moheb Magdy Wadie, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Finerenone Plus SGLT-2 inhibitor (dapagliflozin)
Participants 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
Drug: Finerenone
Finerenone administered orally at a dose of 10 mg once daily.
Drug: dapagliflozine
Dapagliflozin administered orally at a dose of 10 mg once daily.
Active Comparator: SGLT-2 inhibitor (dapagliflozin) alone
Participants 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.
Drug: dapagliflozine
Dapagliflozin administered orally at a dose of 10 mg once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Mortality and Heart Failure Hospitalization
Time Frame: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Incidence of cardiovascular mortality and hospitalization due to heart failure in each treatment group.
Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Number of participants with all-cause mortality in each treatment group.
Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Change in NYHA Functional Class
Time Frame: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Change in New York Heart Association (NYHA) functional class in each treatment group.
Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Change in Serum Potassium Level
Time Frame: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Serum potassium concentration (mmol/L) measured at baseline, Week 4 and Week 12 in each treatment group.
Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) measured at baseline, Week 4 and Week 12 in each treatment group.
Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time Frame: Baseline and Week 12
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.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Mansour Saad Alqahtani, PhD Candidate, Faculty of pharmacy, Mansoura university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 18, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDP.25.08.190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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