Finerenone Plus SGLT2 Inhibitors in Heart Failure

Sponsor
Mansoura University
Study ID
NCT07351864
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    Finerenone administered orally at a dose of 10 mg once daily.
  • dapagliflozine — DRUG
    Dapagliflozin administered orally at a dose of 10 mg once daily.

Study Details

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.

Key Dates

Start date
Jan 18, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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.

Primary Outcome Measure

Cardiovascular Mortality and Heart Failure Hospitalization [ Time Frame: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12) ]

Central Contacts

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