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临床试验/NCT03432468
NCT03432468Unknown不适用

Effect of Fully Blocking Type 1 Angiotensin Receptor on Blood Pressure, Cardiac Structure, Cardiac Function and Cognitive Function in Postmenopausal Hypertensive Women

LanZhou University0 个研究点目标入组 102 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
102
主要终点
Relative indexes of myocardial remodeling

研究概览

简要总结

This study compared the improvements of blood pressure levels, left ventricular hypertrophy, left ventricular diastolic function, vascular function and cognitive function between postmenopausal hypertensive women and age-matched hypertensive male patients through the evaluation of the effects of fully blocked AT1 receptor by valsartan. Additionally, the differences of the above indexes between the patients who were fully blocked AT1 receptor by valsartan and the patients who were treated with a single dose of valsartan treatment were assessed, so as to provide theory basis for clinical treatment of postmenopausal hypertensive women.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of hypertension
  • Women are all postmenopausal
  • Must provide written informed consent

排除标准

  • Secondary hypertension
  • Coronary disease
  • Heart failure
  • Arterial fibrillation
  • Previous myocardial infarction
  • Previous stroke
  • Malignant disease
  • Kidney failure
  • Liver failure
  • Neoplastic disease
  • Severe neurological diseases
  • Severe metabolic or organic decompensation
  • Refuse to sign the informed consent form

研究组 & 干预措施

postmenopausal hypertensive women

Active Comparator

干预措施: Valsartan 1 (Drug)

postmenopausal hypertensive women

Active Comparator

干预措施: Valsartan 80 mg (Drug)

age-matched hypertensive male patients

Placebo Comparator

干预措施: Valsartan 1 (Drug)

结局指标

主要结局

Relative indexes of myocardial remodeling

时间窗: Change from Baseline left ventricular mass index at 12 months.

Cardiac structure (left ventricular mass index in grams for square meter) measurement.

Ambulatory blood pressure monitoring

时间窗: Change from Baseline ABPM at 12 months.

Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.

Sexual hormones

时间窗: Baseline sexual hormones.

Blood samples used to analyze the levels of sexual hormones were collected between morning 8:00 and 9:00 after an overnight fast. The sexual hormones which include prolactin (PRL) and progesterone (P) units on nanogram per millilitre, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) units on millionInternationalUnits per millilitre, testosterone (T) in nanogram per deciliter, estradiol (E2) in picogram per millilitre.

次要结局

未报告次要终点

研究者

发起方
LanZhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jing Yu

Principal Investigator

LanZhou University

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