Evaluation the efficacy of early treatment with dapagliflozin in acute heart failure patients presenting to the emergency department- A randomised controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine the effectiveness of dapagliflozin as a treatment for acute heart failure in reducing the combined primary endpoint: a composite of 30-day all-cause mortality and 30-day re-admission in patients presenting to the medical emergency
研究概览
简要总结
This is an open-label, parallel-group, randomized controlled trial conducted at PGIMER, Chandigarh, designed to evaluate the efficacy of dapagliflozin in reducing all-cause mortality and 30-day hospital readmissions in patients with acute heart failure. Adult patients presenting to the medical emergency with acute heart failure, evidenced by dyspnea at rest or minimal exertion and clinical signs of volume overload, will be screened. Key exclusion criteria include pregnancy/lactation, type 1 diabetes mellitus, cardiogenic shock, end-stage renal disease, chronic liver or lung disease (COPD/ILD), COVID-19, and prior SGLT2 inhibitor use. Participants will be randomized to receive either dapagliflozin 10 mg orally once daily within 24 hours of admission plus standard care, or standard care alone, which includes loop diuretics, vasodilators, and GDMT (ACEi/ARNI, beta-blockers, MRAs) post-stabilization. Outcomes include in-hospital symptomatic improvement, fluid status, diuretic requirements, cardiac biomarkers, and drug safety profiles. Patients will be followed for 30 days post-discharge to assess clinical status and hospital readmissions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •patients present to the medical emergency with acute heart failure NYHA III or IV, with a systolic blood pressure above 100 mmHg, with the following Any one of the following clinical features- elevated JVP, ascites, pedal edema, crackles on auscultation, weight gain of more than 2 kgs over the last 3 days Chest x-ray is suggestive of volume overload, that is, venous cephalization, Kerley B lines, bat-wing patterns, and pleural effusion BNP more than 100 ng per lt or NT-pro-BNP more than 300 ng per lt.
排除标准
- •Type 1 diabetes mellitus Cardiogenic shock (MAP less than 60 mmHg or requiring vasopressor support to maintain MAP or lactate more than 4) History of acute coronary syndrome in the past 30 days (ST elevation or depression more than 1 mm in more than 2 consecutive leads with Trop-I more than 40 ng per L) End-stage renal disease with eGFR of less than 30 ml/min/1.73m2 Chronic liver disease Chronic lung disease (COPD and ILD) COVID-19 Positive patients Non-cardiogenic dyspnea Patient taking any SGLT2i as an outpatient chronic therapy Pregnant or lactating woman Heart failure due to chemotherapy or radiation toxicity The patient had any cardiac surgery or intracardiac implantation or pacemakers, or ventricular assist devices.
结局指标
主要结局
To determine the effectiveness of dapagliflozin as a treatment for acute heart failure in reducing the combined primary endpoint: a composite of 30-day all-cause mortality and 30-day re-admission in patients presenting to the medical emergency
时间窗: 30 days
次要结局
- To evaluate the effect of dapagliflozin in reducing the length of hospital stay.(To evaluate the effect of dapagliflozin on the symptomatic relief of acute heart failure, particularly focusing on the severity of dyspnea as assessed by the dyspnea visual analogue scale between day 1 and day 5.)
研究者
Dr Sourav Paul
Postgraduate Institute of Medical Education and Research, Chandigarh