Finerenone Plus SGLT2 Inhibitors in Heart Failure

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (5)

• All-cause Mortality [Срок оценки: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)]
• Change in NYHA Functional Class [Срок оценки: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)]
• Change in Serum Potassium Level [Срок оценки: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)]
• Change in Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: Up to 12 weeks (assessed at Baseline, Week 4, and Week 12)]
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [Срок оценки: Baseline and Week 12]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

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

Публикации

• 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
• 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 PMID 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. PMID 33264825

Идентификаторы

NCT: NCT07351864 · MDP.25.08.190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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