The Effect of Dapagliflozin on Patients With Cardiomyopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is a double-blind randomized controlled trial. Neither the participants nor the investigators (including care providers and outcome assessors) are aware of the treatment assignments. This masking minimizes bias in treatment administration, patient perception, and outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Type 1 diabetes mellitus
- •Urinary tract or genital infection
- •Hypovolemia
- •Diabetic ketoacidosis
- •Serum glucose < 80 mg/dL at enrollment
- •Systolic blood pressure < 90 mmHg at enrollment
- •History of hypersensitivity to any SGLT2 inhibitor
- •Pregnant or breastfeeding women
- •Severe primary valvular lesion requiring intervention
- •Severe hepatic impairment (Child-Pugh class C)
- •Estimated glomerular filtration rate < 25 mL/min/1.73 m² (by MDRD equation)
研究组 & 干预措施
Active Comparator
Participants will receive standard intravenous diuretic therapy alone, without dapagliflozin.
Intervention(s):
Drug: Intravenous Diuretic
Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol
干预措施: Diuretic (Drug)
Dapagliflozin + Diuretic (Intervention Group)
Participants will receive dapagliflozin 10 mg orally once daily in addition to standard intravenous diuretic therapy.
Intervention(s):
Drug: Dapagliflozin (DAPA)
Dose: 10 mg once daily
Route: Oral
Other Name(s): Forxiga
Drug: Intravenous Diuretic
Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol
干预措施: Diuretic (Drug)
Dapagliflozin + Diuretic (Intervention Group)
Participants will receive dapagliflozin 10 mg orally once daily in addition to standard intravenous diuretic therapy.
Intervention(s):
Drug: Dapagliflozin (DAPA)
Dose: 10 mg once daily
Route: Oral
Other Name(s): Forxiga
Drug: Intravenous Diuretic
Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol
干预措施: Dapagliflozin (DAPA) (Drug)
结局指标
主要结局
Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS)
时间窗: Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission)
To evaluate the effect of dapagliflozin on pulmonary congestion in patients hospitalized with acute heart failure, using lung ultrasound to measure the number of B-lines at defined intervals during hospitalization.
次要结局
- Effect of Dapagliflozin on Renal Biomarker NGAL(Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days))
- Change in NT-proBNP Levels(Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days))
- Effect of Dapagliflozin on Hospital Length of Stay(From hospital admission to hospital discharge (an average of 7 days))
- Incidence of Acute Kidney Injury (AKI) Based on KDIGO Criteria(From admission (Day 1) through hospital discharge (up to 14 days))
- Change in Net Fluid Balance(Day 1, Day 2, and Day 3 of hospitalization)
- Change in sST2 Levels(Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days))
- Change in CA-125 Levels(Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days))
研究者
May Mohamed Abdalla
Senior teaching assistant
Cairo University