A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

Официальное название

Combined Efficacy and Safety of an Early, Intensive, Management Strategy With Finerenone and SGLT2 Inhibitor in Patients Hospitalized With Heart Failure (CONFIRMATION-HF)

Обзор

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Подробное описание

This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).

Вмешательства

• Препарат Finerenone
  Oral finerenone.
• Препарат Empagliflozin
  Oral empagliflozin.

Первичные конечные точки

• Clinical benefit [Срок оценки: 6 months]
• Number of serious adverse events (AEs). [Срок оценки: 6 months]
• Number of adverse events leading to discontinuation of study drug. [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Time to first death from any cause or HF event. [Срок оценки: 6 months]
• Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS). [Срок оценки: 6 months]
• Number of HF events from baseline to Day 90. [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
• Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
• Current hospitalization or recently discharged with the primary diagnosis of heart failure
• Heart failure signs and symptoms at the time of hospital admission
• Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission
• Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)
• Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).
• Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Критерии исключения

• Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis
• Documented prior history of severe hyperkalemia in the setting of MRA use
• Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i
• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² and/or potassium >5.0 mmol/L
• Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
• Prior or planned heart transplant
• Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure
• Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
• Probable alternative cause of participant's heart failure symptoms
• Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
• Known hypersensitivity to the IP (active substance or excipients)
• Any other condition or therapy which would make the patient unsuitable for this study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 34 центра

• CON-21036, Rio Branco, Acre — Rio Branco
• CON-21064, Arapiraca, Alagoas, Brazil — Arapiraca
• CON-21017, Linhares, Espirito Santo — Linhares
• CON-21032, Salvador, Bahia — Salvador
• CON-21028, Brasilia, Distrito Federal — Brasília
• CON-21053, Aparecida de Goiânia, Goias — Aparecida de Goiânia
• CON-21003 Goiania, Goias Investigational Site — Goiânia
• CON-21020, Belo Horizonte, Minas Gerais — Belo Horizonte
• … и ещё 26 центров

США · 33 центра

• CON-10004 Fairhope, AL Investigational Site — Fairhope
• CON-10075 El Centro, CA Investigational Site — El Centro
• CON-10024 Sacramento, CA Investigational Site — Sacramento
• CON-10023, San Francisco, CA — San Francisco
• CON-10109, Van Nuys, CA — Van Nuys
• CON-10001, Aurora, CO — Aurora
• CON-10005, Denver, CO — Denver
• CON-10078, Hialeah, FL — Hialeah
• … и ещё 25 центров

Канада · 10 центров

• CON-11011, Edmonton, AB — Edmonton
• CON-11012 Surry, BC Investigational Site — Surrey
• CON-11016, Sudbury, ON — Greater Sudbury
• CON-11010, London, ON — London
• CON-11007 North York, ON Investigational Site — North York
• CON-11008, Toronto, ON — Toronto
• CON-11019, Toronto, ON — Toronto
• CON-11001, Toronto, ON — Toronto
• … и ещё 2 центра

Китай · 10 центров

• CON-56002, Guangzhou, Guangdong province — Гуанчжоу
• CON-56008, Changsha, Hunan — Чанша
• CON-56004, Jinan, Shandong Province — Цзинань
• … и ещё 7 центров

Испания · 6 центров

Список центров уточняется — проверьте первичный протокол.

Sri Lanka · 4 центра

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Великобритания · 4 центра

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Индия · 3 центра

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Идентификаторы

NCT: NCT06024746 · 202303CPC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗