Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure

Официальное название

Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial

Обзор

This study is a multicenter, double-blind, randomized, placebo-controlled trial. The purpose is to evaluate whether treatment with finerenone in patients with symptomatic severe aortic stenosis undergoing TAVI, and heart failure with LVEF ≥40% is associated with a reduction in the composite endpoint of all-cause mortality or worsening of heart failure. Participants are patients with symptomatic aortic stenosis undergoing TAVI and heart failure with LVEF≥40%. Eligible patients will be randomly assigned in a 1:1 ratio to either the finerenone group or the placebo group. Patients meeting all inclusion criteria and not any exclusion criteria will be invited to participate before discharge. All enrolled patients will consecutively receive treatment, during which serum potassium and estimated glomerular filtration rate will be closely monitored. Follow-up will be conducted at 30 days, 12 months at clinic, and 3 months, 6 months, 9 months and every 6 months after 12 months of enrollment online or via telephone (at clinic if necessary). The final visit will be conducted for all enrolled patients at the end of the study.

Подробное описание

Inclusion criteria:

1. Age ≥ 65 years. 2. Patients with severe aortic stenosis (aortic valve area \< 1.0 cm2 or indexed area \< 0.6 cm2/m2, or mean transvalvular aortic gradient ≥ 40 mmHg or velocity of blood flow through the valve ≥ 4.0 m/s) undergoing transfemoral TAVI. 3. New York Heart Association class ≥ II. 4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI. 5. Informed consent has been signed.

Exclusion criteria:

1. Untreated serum/plasma potassium \> 5.0 mmol/L during the screening period or randomization visit. 2. Estimated glomerular filtration rate \< 25 ml/min/1.73 m². 3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization. 4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists. 5. Pregnant or breastfeeding patients. 6. Life expectancy \< 1 year. 7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

Вмешательства

• Препарат Finerenone
  Oral treatment with finerenone daily: * For participants with an eGFR ≤60 mL/min/1.73 m2: Starting dose is 10 mg OD and target dose 20 mg OD. * For participants with an eGFR \>60 mL/min/1.73 m2: Starting dose is 20 mg OD and target dose 40 mg OD.
• Препарат Placebo
  Oral treatment with placebo daily

Первичные конечные точки

• A composite of all-cause mortality or worsening of heart failure (hospitalization for HF or urgent HF visit), any of the first occurrence during the follow-up. [Срок оценки: at least 12 months]

Вторичные конечные точки (12)

• Total number of worsening of heart failure. [Срок оценки: at least 12 months]
• Total number of worsening of heart failure and cardiovascular mortality. [Срок оценки: at least 12 months]
• Total number of worsening of heart failure and all-cause mortality. [Срок оценки: at least 12 months]
• Time to cardiovascular mortality. [Срок оценки: at least 12 months]
• Time to all-cause mortality. [Срок оценки: at least 12 months]
• Time to first worsening of heart failure. [Срок оценки: at least 12 months]
• Time to cardiovascular mortality or first worsening of heart failure. [Срок оценки: at least 12 months]
• Time to cardiovascular mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes. [Срок оценки: at least 12 months]
• Time to all-cause mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes. [Срок оценки: at least 12 months]
• Change from baseline in KCCQ score at 30-day and 12-month follow-up. [Срок оценки: 30-day and 12-month follow-up]
• Improvement from baseline in NYHA classification at 30-day and 12-month follow-up. [Срок оценки: 30-day and 12-month follow-up]
• Change from baseline in LVMI at 30-day and 12-month follow-up. [Срок оценки: 30-day and 12-month follow-up]

Критерии участия

Критерии включения

• Age ≥ 65 years.
• Patients with severe aortic stenosis (aortic valve area < 1.0 cm2 or indexed area < 0.6 cm2/m2, or mean transvalvular aortic gradient ≥ 40 mmHg or velocity of blood flow through the valve ≥ 4.0 m/s) undergoing transfemoral TAVI.
• New York Heart Association class ≥ II.
• Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
• Informed consent has been signed.

Критерии исключения

• Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
• Estimated glomerular filtration rate < 25 ml/min/1.73 m².
• Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
• Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
• Pregnant or breastfeeding patients.
• Life expectancy < 1 year.
• Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 61 центр

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• The First Affiliated Hospital of University of Science and Technology of China — Хэфэй
• Affiliated Beijing Chaoyang Hospital of Capital Medical University — Пекин
• Beijing Anzhen Hospital Affiliated to Capital Medical University — Пекин
• Chinese People's Liberation Army General Hospital — Пекин
• Fuwai Hospital Chinese Academy of Medical Sciences — Пекин
• Peking University Third Hospital — Пекин
• Army Medical Center of the People's Liberation Army — Чунцин
• … и ещё 53 центра

Идентификаторы

NCT: NCT07575672 · 2026-0377

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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