EFFICACY OF SGLT2 INHIBITORS ON LV DIASTOLIC DYSFUNCTION AND PREVENTION OF NEW ONSET ATRIAL FIBRILLATION IN DIASTOLIC HEART FAILURE PATIENTS
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Measuring improvemnt in LV diastolic function with 2D Echocardiography
研究概览
简要总结
Sodium glucose co-transporter 2 (SGLT2) Inhibitors has proven to reduce the combined risk of hospitalization for heart failure or cardiovascular death among patients with diastolic heart failure and aids in Decongestion- thus improving Diastolic function and helps in improving Exercise capacity. SGLT2 inhibitors (SGLT2i) have demonstrated robust benefits in terms of the prevention of heart failure (HF) and the reduction in cardiovascular mortality. In this study, we are going to investigate the efficacy of SGLT2 Inhibitors on left ventricular diastolic parameters by comparing 2 groups- one group taking Dapagliflozin and other group taking Telmisartan and followed up for 6 months. Echo LV diastolic parameters such as a mitral peak E-wave velocity to early mitral or septal annular tissue Doppler velocity ratio (E/e′) are measured at end of 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients aged more than 18 years of age diagnosed with Diastolic Heart failure are included Diastolic Heart failure patients under treatment with either Dapagliflozin 10 mg or Telmisartan 40mg LVEF> 45% documented by echocardiography.
排除标准
- •Patients with systolic Heart failure with EF< 45% Uncontrolled Hypertension with systolic BP>140 mmhg or Diastolic Bp>90 mmhgare excluded Uncontrolled Diabetis mellitus with FBS>125 mg/dl or PPBS>200 mg/dl are excluded Patients who need step up treatment in Baseline Regimen dosage for Hypertension or Diabetes mellitus during course of study are excluded Patients who develop acute exacerbation or symptoms of congestive HF or those who need treatment with Diuretics during course of study are excluded Presence of cardiomyopathy due to infiltrative disorders- amyloidosis, sarcoidosis are excluded Dyspnea due to primary lung disorder.
结局指标
主要结局
Measuring improvemnt in LV diastolic function with 2D Echocardiography
时间窗: Baseline, and 24 weeks
次要结局
- First occurrence of decline in renal function from baseline(Baseline, 24 weeks)
研究者
DrSubbiah
Saveetha Medical college and Hospital