Effect of Sacubitril/Valsartan on Urinary Microalbumin and Pulse Wave Velocity in Perimenopausal Patients With Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Blood pressure，24 hour automatic blood pressure monitoring，home blood pressure monitoring，Office blood pressure
研究概览
简要总结
To explore the efficacy of Sacubitril/Valsartan in the treatment of perimenopausal hypertensive patients, as well as the difference between the antihypertensive efficacy and valsartan, the therapeutic effect of its exposure to different factors and the protection of target organs.To provide reference for the clinical treatment of perimenopausal hypertension patients with shakubactrivalsartan.
- To evaluate the effects of Sacubitril/Valsartan on urinary microalbumin and pulse wave velocity in perimenopausal hypertension patients.
- To evaluate the clinical application of Sacubitril/Valsartan in the treatment of perimenopausal hypertension, so as to improve the blood pressure management ability and control rate of patients with such hypertension.
详细描述
A total of 264 cases of perimenopausal patients with essential hypertension who were admitted to Department of Cardiology, Second Hospital of Lanzhou University,from January, 2020 to March,2021 will be enrolled and randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan or 80-320 mg of Valsartan.The general information, menstrual history, cardiac ultrasound, urinal-renal function, PWV, baseline blood pressure, post-medication blood pressure, whether to use antihypertensive drugs and the type of antihypertensive drugs of the patients were enrolled.After 12 weeks of drug intervention, left ventricular mass indexwere measured by cardiac ultrasound, PWV, urinary microalbinin, 24-hour ambulatory blood pressure monitoring, biochemical indicators will be collected.SPSS22.0 statistical software was used for statistical analysis of PWV, urinary microalbumin, blood pressure and other results by paired data t-test, and the chi-square test was used for non-count data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with essential hypertension（SBP>140 and <180 mmHg, and/or DBP>90 and <110 mmHg)）were diagnosed according to the hypertension diagnostic criteria of the Chinese Guidelines for Hypertension (2018 Revised Edition)；
- •Female aged 45-55 years old and meeting the perimenopausal criteria in the STRAE+10;
- •No other complications, no treatment or ongoing antihypertensive therapy (SBP ≥140mmHg or Diastolic BP ≥90mmHg)；
- •Agree to participate in the study and sign the informed consent；
排除标准
- •Secondary hypertension；
- •History of angioedema；
- •Heart failure NYHA grade III or above (excluding grade III)；
- •Liver and kidney dysfunction (ALT or AST≥ three times the upper limit of normal value, that is, ALT≥120U/L,AST≥120U/L, creatinine clearance < 30ml/min);
- •Hyperkalemia (serum potassium ≥5.5mmol/L);
- •Moderate or above anemia (HGB≤90g/L);
- •Bilateral renal artery stenosis;
- •History of stroke;
研究组 & 干预措施
Sacubitril/Valsartan
receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan
干预措施: Sacubitril/Valsartan (Drug)
Valsartan
receive once-daily treatment with 80-320 mg of Valsartan
干预措施: Valsartan (Drug)
结局指标
主要结局
Blood pressure，24 hour automatic blood pressure monitoring，home blood pressure monitoring，Office blood pressure
时间窗: Evaluation at 12 weeks of treatment will be reported
Changes in this major indicators were detected before and after drug treatment in both groups
urinary microalbuminuria
时间窗: Evaluation at 12 weeks of treatment will be reported
Changes in this major indicators were detected before and after drug treatment in both groups
pulse wave velocity
时间窗: Evaluation at 12 weeks of treatment will be reported
Changes in this major indicators were detected before and after drug treatment in both groups
ventricular mass indexwere measured by cardiac ultrasound
时间窗: Evaluation at 12 weeks of treatment will be reported
Changes in this major indicators were detected before and after drug treatment in both groups
次要结局
- Adverse events(During the drug intervention up to 30 days,60 days and 80days,it will bereported in the final.)
研究者
Ying Pei
house physician
LanZhou University