Effect of dapagliflozin 10 mg as add on therapy to existing antihypertensive medications on blood pressure and metabolic parameters in patients with uncontrolled hypertension attending a tertiary care hospital: An open label randomised interventional study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 198
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the effect of dapagliflozin 10 milligrams once daily as add on therapy to existing antihypertensive medications on blood pressure and metabolic parameters in patients with uncontrolled hypertension attending a tertiary care hospital. This is an open label randomized interventional study. Eligible patients aged 18 to 75 years with uncontrolled blood pressure despite receiving antihypertensive therapy comprising one or two agents such as Telmisartan 40 milligrams once daily, Amlodipine 5 milligrams once daily, Enalapril 5 milligrams once daily or their combination will be randomized into two groups. One group will receive dapagliflozin in addition to standard therapy and the other group will continue standard therapy alone. Participants will be followed for 12 weeks. The primary outcome is change in systolic blood pressure and diastolic blood pressure. Secondary outcomes include changes in metabolic parameters, renal function and echocardiographic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Diagnosed patients of hypertension with uncontrolled blood pressure of 140/90 mm of mercury or higher while receiving one or two antihypertensive drugs such as Telmisartan 40 mg once daily, Amlodipine 5 mg once daily, Enalapril 5 mg once daily, or their combination, with or without type 2 diabetes mellitus, will be considered for enrollment.
- •Patients should be above 18 years of age and willing to provide written informed consent.
排除标准
- •Patients with secondary hypertension or accelerated hypertension.
- •Patients with known hypersensitivity to sodium glucose co transporter 2 inhibitors.
- •Patients already receiving sodium glucose co transporter 2 inhibitors.
- •Pregnant or lactating women.
- •Patients with active urinary tract infection or genital mycotic infection.
研究者
Dr Richa Sharma
Indira Gandhi Medical College Shimla