SGLT2i, ARNi And Diuretic Use In Patients With Heart Failure With Preserved And Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change in loop diuretic and sacubitril/valsartan dose
研究概览
简要总结
SGLT2 inhibitors are a class of medications approved for use in type 2 diabetes to treat hyperglycemia. Patients with HFrEF typically receive therapy with loop diuretics, considered the standard kind of diuretics. SGLT2i have demonstrated the capability to reduce the likelihood of hospitalisation for heart failure (HF), independent of diabetes status. It has also presented a reduced pace of decrease in the estimated glomerular filtration rate (GFR). These findings are backed by many trials. Renal assessments from certain clinical trials offer further confirmation that SGLT2 inhibitors possess kidney-protective effects, leading to a notably decreased risk of advancing to macroalbuminuria or experiencing clinically significant renal outcomes, such as doubling of serum creatinine levels and the need for renal replacement therapy. SGLT2 inhibitors possess the potential to exacerbate the diuretic impact of traditional treatments, which might result in a decrease in volume. On the contrary, considering SGLT2 inhibitors exert a minimal diuretic effect, they are unlikely to have an enormous effect on the strong action of loop diuretics. The effects of SGLT2 inhibitor administration to HFrEF who were already on sacubitril/valsartan were investigated in a different study. According to this investigation, the combination of the aforementioned drugs could assist patients with HFrEF have even fewer instances of morbidity and death.
Numerous investigations have exhibited the possible therapeutic effectiveness of SGLT2i in the management of cardiovascular events via diverse methods. However, the impact of SGLT2i on the dosage of loop diuretics and sacubitril/valsartan while treating heart failure patients who are on background diuretics and sacubitril/valsartan has not been well studied. Therefore, further research must be done to fully comprehend this process. This study intends to investigate the impact of SGLT2i on loop diuretic and sacubitril/valsartan dose in heart failure patients already on diuretics and sacubitril/valsartan and scrutinize the shift in loop diuretic dose and sacubitril/valsartan over a certain period.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Age equal to or greater than 18 years old EF lesser than or equal to 40 percent for HFrEF and EF greater than or equal to 50 percent for HFpEF with or without Type-2 diabetes mellitus Initiation of SGLT2i Prescribed a loop diuretic and sacubitril valsartan prior to the initiation of SGLT2i.
排除标准
- •Estimated glomerular filtration rate less than 20 mL per min per 1.73 meter square or undergoing dialysis Chronic heart failure persisting for a minimum of 6 months, with an ejection fraction below 25 percent at the commencement of SGLT2 inhibitor therapy Discontinuation of SGLT2 inhibitors Inadequate data in the patient medical records.
结局指标
主要结局
Change in loop diuretic and sacubitril/valsartan dose
时间窗: Baseline and after dose alteration of loop diuretics, ARNi and SGLT2i
次要结局
- Dose change in other diuretic medications, Clinical parameters: RFT, Hematocrit (%), NYHA classification, electrolytes levels, lipid levels, blood sugar levels, ADRs to medications during the study period, Discontinuation of SGLT2 inhibitors because of volume depletion, Discontinuation of SGLT2 inhibitors due to other adverse reactions(Baseline and after dose alteration of loop diuretics, ARNi and SGLT2i)
研究者
Mohammad Saabiq Samad
NGSM Institute of Pharmaceutical Sciences
