Effect of Fully Blocking Type 1 Angiotensin Receptor on Target Organ Damage of Postmenopausal Hypertensive Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan 1
* Drug: Valsartan 80 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of hypertension Women are all postmenopausal Must provide written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: postmenopausal hypertensive women<br> | Drug: Valsartan 1<br>* the high dose of valsartan<br>Drug: Valsartan 80 mg<br>* a single dose of valsartan<br>|
| Placebo Comparator: age-matched hypertensive male patients<br> | Drug: Valsartan 1<br>* the high dose of valsartan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative indexes of myocardial remodeling | Cardiac structure (left ventricular mass index in grams for square meter) measurement. | Change from Baseline left ventricular mass index at 6 months. | 
| Relative indexes of myocardial remodeling | Cardiac structure (left ventricular mass index in grams for square meter) measurement. | Change from Baseline left ventricular mass index at 12 months. | 
| Ambulatory blood pressure monitoring | Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment. | Change from Baseline ABPM at 6 months. | 
| Ambulatory blood pressure monitoring | Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment. | Change from Baseline ABPM at 12 months. | 
| 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. | Baseline sexual hormones. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Left Ventricular Hypertrophy, Women