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

Not Applicable

• Conditions: Hypertension
• Interventions: Drug: Valsartan 1; Drug: Valsartan 80 mg

• Registration Number: NCT03432468
• Lead Sponsor: LanZhou University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-14
• Last Update Submitted: 2018-03-10
• Last Update Posted: 2018-03-13
• Study Start: 2018-04-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
postmenopausal hypertensive women	Valsartan 1	-
postmenopausal hypertensive women	Valsartan 80 mg	-
age-matched hypertensive male patients	Valsartan 1	-

Primary Outcome Measures

Name	Time	Method
Relative indexes of myocardial remodeling	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	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	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.