Comparison of SGLT2 inhibitor monotherapy and combination therapy with Loop Diuretics in Heart Failure among diabetic and non-diabetic individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To compare the impact on clinical outcomes, renal function, and cardiac biomarkers between SGLT2
研究概览
简要总结
This prospective longitudinal study will evaluate and compare the clinical outcomes, renal function, and cardiac biomarker changes in patients with heart failure receiving SGLT2 inhibitor monotherapy and those receiving a combination of SGLT2 inhibitors with loop diuretics. The study will include both diabetic and non-diabetic individuals diagnosed with heart failure and will monitor parameters such as BNP or NT-pro BNP levels, electrolyte balance, urine output and NYHA functional class over the study period. The findings are expected to provide insights into optimizing therapeutic strategies and ensuring safe, effective and evidence-based management of heart failure.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged eighteen years and above Diagnosed with heart failure either reduced or preserved ejection fraction (ICD code I50.0 to I50.9) Prescribed either SGLT2 inhibitor monotherapy or combination therapy with SGLT2 inhibitor and loop diuretic Includes both diabetic and non diabetic individuals (ICD code E11.0 to E11.9) Availability of complete clinical records including medication history, laboratory investigations and outcome data Patients managed in either inpatient or outpatient settings.
排除标准
- •Pregnant women and lactating women Patients with incomplete or missing data Patients with end stage renal disease or those on dialysis Patients receiving SGLT2 inhibitors exclusively for glycemic control without a documented diagnosis of heart failure Patients with chronic illnesses such as malignancy, human immunodeficiency virus infection, nutritional deficiency disorders or gestational diabetes.
结局指标
主要结局
To compare the impact on clinical outcomes, renal function, and cardiac biomarkers between SGLT2
时间窗: At Baseline, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline, 52 weeks after baseline, 104 weeks after baseline
inhibitor monotherapy and combination therapy with loop diuretics in heart failure patients.
时间窗: At Baseline, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline, 52 weeks after baseline, 104 weeks after baseline
次要结局
- To perform subgroup analyses to determine if the observed differences in clinical outcomes, renal(function, & cardiac biomarkers vary between diabetic & non-diabetic heart failure patients receiving)
研究者
Disha Shetty
Manipal College of Pharmaceutical Sciences