Finerenone Plus SGLT2 Inhibitors in Heart Failure

NCT07351864 | Not Yet Recruiting Phase 4

• 1 other identifier: MDP.25.08.190
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure

Keywords

Finerenone; SGLT2 inhibitor; Dapagliflozin; Heart failure therapy; Cardioprotection

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Mortality and Heart Failure Hospitalization

  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 Outcomes (5)

• All-cause Mortality

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

• Change in NYHA Functional Class

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

• Change in Serum Potassium Level

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

• Change in Estimated Glomerular Filtration Rate (eGFR)

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

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

  Baseline and Week 12

Study Arms (2)

Finerenone Plus SGLT-2 inhibitor (dapagliflozin)

EXPERIMENTAL

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; Drug: dapagliflozine

SGLT-2 inhibitor (dapagliflozin) alone

ACTIVE COMPARATOR

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

Interventions

Finerenone DRUG

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

Finerenone Plus SGLT-2 inhibitor (dapagliflozin)

dapagliflozine DRUG

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

Finerenone Plus SGLT-2 inhibitor (dapagliflozin); SGLT-2 inhibitor (dapagliflozin) alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals, Cardiology Department (Specialized Medical Hospital)

Al Mansurah, Egypt

Location

Related Publications (3)

• 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.

  PMID: 34775784 RESULT

• 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.

  PMID: 38692445 RESULT

• 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.

  PMID: 33264825 RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

finerenone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mansour Saad Alqahtani, PhD Candidate

  Faculty of pharmacy, Mansoura university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mansour Saad Alqahtani, PhD Candidate

CONTACT

+966554433848; mushyt2003@gmail.com

Moheb Magdy Wadie, Phd

CONTACT

+201222990072; Muheb2001@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate in Clinical Pharmacy

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 20, 2026
• Study Start: January 18, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)