Идёт набор NCT07076615

The Effect of Dapagliflozin on Patients With Cardiomyopathy

Фаза IV С лечением Acute Decompensated Heart Failure (ADHF)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Dapagliflozin (DAPA), Diuretic.
Кому может быть актуально: Состояния в реестре: Acute Decompensated Heart Failure (ADHF). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This randomized controlled trial evaluates the efficacy and tolerability of early initiation of dapagliflozin in adult patients hospitalized with acute heart failure (AHF). The study aims to assess the effect of dapagliflozin on pulmonary congestion as measured by lung ultrasound (LUS), length of hospital stay, and cardiac and renal biomarkers. A total of 100 patients will be randomized into two groups: one receiving dapagliflozin plus diuretics and the other receiving diuretics alone. Key outcomes include the reduction of extravascular lung water (assessed by B-lines in LUS), improved diuretic response, changes in NT-proBNP, sST2, CA-125, and NGAL levels, and incidence of acute kidney injury. The study will be conducted at the Cardiology and ICU departments at Kasr Al Ainy Hospital, Cairo University

Подробное описание

Acute Heart Failure (AHF) is a life-threatening syndrome and a leading cause of hospitalization worldwide. Effective decongestion during AHF episodes is essential for improving patient outcomes and reducing hospital readmissions. Sodium-glucose co-transporter 2 (SGLT2) inhibitors, particularly dapagliflozin, have shown significant promise in improving cardiovascular outcomes in chronic heart failure; however, their role during acute episodes remains under active investigation.

This prospective, randomized controlled trial aims to assess the efficacy and safety of early dapagliflozin initiation in hospitalized adult patients with AHF, irrespective of diabetes status. A total of 100 patients admitted to the Cardiology and Intensive Care Departments of Kasr Al Ainy Hospital, Cairo University, will be enrolled and randomized (1:1) to either standard diuretic therapy alone or dapagliflozin (10 mg once daily) plus diuretics.

The study's primary endpoint is the degree of pulmonary congestion, evaluated through lung ultrasound (LUS) using an 8-zone scanning protocol and quantification of B-lines. Secondary outcomes include hospital length of stay, diuretic response, changes in cardiac biomarkers (NT-proBNP, sST2, and CA-125), renal biomarker NGAL, and incidence of acute kidney injury.

LUS and echocardiography will be performed by certified intensivists using standardized protocols. Biomarkers will be measured via ELISA kits at three time points: within 24 hours of admission, and at discharge.

The hypothesis is that early use of dapagliflozin in AHF enhances decongestion, improves natriuretic response, and enables earlier hospital discharge without increasing adverse renal or metabolic events.

The results of this study will provide valuable insights into the use of SGLT2 inhibitors during the acute phase of heart failure and may inform future clinical practice guidelines.

Вмешательства

Препарат Dapagliflozin (DAPA)
Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy
Препарат Diuretic
Arm B (Control Group): Receives standard intravenous diuretic therapy alone

Первичные конечные точки

Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS) [Срок оценки: Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission)]

Вторичные конечные точки (7)

Effect of Dapagliflozin on Hospital Length of Stay [Срок оценки: From hospital admission to hospital discharge (an average of 7 days)]
Effect of Dapagliflozin on Renal Biomarker NGAL [Срок оценки: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)]
Change in NT-proBNP Levels [Срок оценки: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)]
Change in Net Fluid Balance [Срок оценки: Day 1, Day 2, and Day 3 of hospitalization]
Incidence of Acute Kidney Injury (AKI) Based on KDIGO Criteria [Срок оценки: From admission (Day 1) through hospital discharge (up to 14 days)]
Change in sST2 Levels [Срок оценки: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)]
Change in CA-125 Levels [Срок оценки: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)]

Критерии участия

Критерии включения

18 years or older
Acute heart failure as defined by the 2022 American College of Cardiology/American Heart Association (Heidenreich et al., 2022) or 2021 European Society of Cardiology (McDonagh et al., 2021) guidelines, based on typical symptoms and signs of heart failure requiring hospitalization or emergency department visit
Elevated natriuretic peptide levels
Includes heart failure with reduced, mildly reduced, or preserved ejection fraction
Planned use of intravenous diuretic therapy