A Randomized Open Label Trial to Compare the Efficacy and Safety of Dapagliflozin and Empagliflozin in Heart Failure Patients Attending a Tertiary Care Centre in Puducherry
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcomes of this study are twofold. First, the comparative effect of Dapagliflozin and Empagliflozin on reducing cardiovascular mortality and hospitalization due to heart failure will be assessed. Second, echocardiographic improvements will be evaluated by comparing Left Ventricular Ejection Fraction (LVEF), Left Atrial Volume Index (LAVi), and Left Ventricular End-Diastolic Diameter (LVEDD) between the two groups.
研究概览
简要总结
Written consent forms will be obtained from the study participants. Patients diagnosed with heart failure will be divided into two groups by lottery method. The sequence will be generated in advance ensuring equal allocation to both groups in a 1:1 ratio. Group 1- will be given Dapagliflozin 10mg OD for 1 year. Group 2- will be given Empagliflozin 10mg OD 1 year. Standard heart failure therapy continued for both groups. Demographic profile, vital signs, laboratory investigations including serum electrolytes, blood glucose levels (HbA1C), Renal function tests, urine routine analysis, Cardiac function indices including NYHA functional class, transthoracic echocardiographic indicators containing LVEF, left ventricular end-diastolic diameter (LVEDD) and LA volume index will be recorded before the treatment, after 6 months and 12 months of therapy. The hospitalization rates will be estimated between both groups. The changes in echo parameters, improvement in functional class (NYHA class), changes in renal parameters, serum electrolytes and urine routine analysis will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 years or older who consents to participate in the study.
- •Patients with newly diagnosed heart failure and who already diagnosed with HF but not receiving SGLT2 inhibitors.
- •Patients with or without co-morbidities.
排除标准
- •Patients with type 1 diabetes mellitus.
- •Patients with HbA1c more than 10 percent.
- •Severe renal impairment (eGFR less than 30mL per min per 1.73m²).
- •History of diabetic ketoacidosis.
- •History of allergic reactions to SGLT2 inhibitors.
- •History of active genitourinary tract infection.
- •Pregnancy or Lactation.
结局指标
主要结局
The primary outcomes of this study are twofold. First, the comparative effect of Dapagliflozin and Empagliflozin on reducing cardiovascular mortality and hospitalization due to heart failure will be assessed. Second, echocardiographic improvements will be evaluated by comparing Left Ventricular Ejection Fraction (LVEF), Left Atrial Volume Index (LAVi), and Left Ventricular End-Diastolic Diameter (LVEDD) between the two groups.
时间窗: At baseline, 6 months and 12 months.
次要结局
- The secondary outcomes involve assessing the improvement in functional status based on the New York Heart Association (NYHA) functional classification, measured at baseline and at 6 months and 12 months. Adverse effects will be monitored throughout 1 year, including the incidence of genitourinary infections and other reported events. Renal function tests (serum creatinine and estimated GFR) and serum electrolytes (sodium and potassium) will be evaluated at baseline, at 6 months, and at 12 months.(At baseline, 6 months and 12 months.)
研究者
Dr Geerthana Thamizhvanan
Sri Venkateshwaraa Medical College Hospital and Research Centre