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

Mansoura University

Status and phase: Not yet enrolling; Phase 4

Conditions: Heart Failure

Treatments: Drug: Finerenone; Drug: dapagliflozine

Study type: Interventional

Funder types: Other

Identifiers

NCT07351864

MDP.25.08.190

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Finerenone Plus SGLT-2 inhibitor (dapagliflozin)

Experimental group

Description:

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

Treatment:

Drug: dapagliflozine

Drug: Finerenone

SGLT-2 inhibitor (dapagliflozin) alone

Active Comparator group

Description:

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.

Treatment:

Drug: dapagliflozine