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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03432468
• Other study ID #: LanZhouU
• Status: Not yet recruiting
• Phase: N/A
• First received: January 19, 2018
• Last updated: March 10, 2018
• Start date: April 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2018
• Source: LanZhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Valsartan 1
the high dose of valsartan
• Valsartan 80 mg
a single dose of valsartan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LanZhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.