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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Drug: Valsartan 1; Drug: Valsartan 80 mg

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: LanZhou University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Hypertension; Women; Left Ventricular Hypertrophy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: LanZhouU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No