Efficacy and Safety of addition of Dapagliflozin to conventional therapy in patients of Heart Failure with Mildly Reduced and Preserved Ejection Fraction: A placebo controlled double blind study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of Dapagliflozin over placebo (blood and eco-cardiogram parameters) when added to standard regimen in HFpEF and HFmrEF
研究概览
简要总结
Heart Failure is a complex clinicalsyndrome that results from any structural or functional impairment ofventricular filling or ejection of blood leading to cardinal manifestations ofdyspnea, fatigue and fluid retention
•Treatmentof HFpEF and HFmrEF is heavily symptom based without specific pharmacologicaltherapies to modify disease progression.
•Dapagliflozinis Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor originally developed asglucose lowering agent. Later studies have shown to reduce hospitalization inHeart Failure patients with reduced Ejection Fraction.
•Whetherthe benefits of SGLT2 inhibitors observed in HFrEF extend to patients withHFpEF is unknown.
•SGLT2Inhibitors are found helpful in improving congestion, improved renal function,diastolic function, reducing visceral fat (including epidural fat), reducingatrial stiffness, have favourable effects on endothelial function andinflammation. All these are important mechanisms by which pathogenesis of HFpEFcan be improved.
Therefore,we have planned this study to find the efficacy of dapagliflozin in HFmrEF andHFpEF and to establish its effectiveness in full spectrum of Ejection Fraction
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing singned informed consent 2.Patients with documented diagnosis of HFpEF and HFmrEF with medical history of symptoms and signs of Heart Failure 3.Patients with LVEF 40-60% or evidence of structural Heat disease.
排除标准
- •1.Patients who are not willing to sign informed consent.
- •2.Patients with LVEF <40% 3.Patients with eGFR <25ml/min/1.73m3 4.Patients who are intolerance to Dapagliflozin.
结局指标
主要结局
Efficacy of Dapagliflozin over placebo (blood and eco-cardiogram parameters) when added to standard regimen in HFpEF and HFmrEF
时间窗: At baseline, 6 months
次要结局
- 1.Safety and tolerability of Dapagliflozin(3.improvement in patent reported outcomes measured by KCCQ-12(Kansas City Cardiomyopathy Questioner))