NCT03432468

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 13, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

January 19, 2018

Last Update Submit

March 10, 2018

Conditions

Hypertension

Keywords

HypertensionLeft Ventricular HypertrophyWomen

Outcome Measures

Primary Outcomes (5)

  • 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.

Study Arms (2)

postmenopausal hypertensive women

ACTIVE COMPARATOR
Drug: Valsartan 1Drug: Valsartan 80 mg

age-matched hypertensive male patients

PLACEBO COMPARATOR
Drug: Valsartan 1

Interventions

Valsartan 1DRUG

the high dose of valsartan

age-matched hypertensive male patientspostmenopausal hypertensive women
Valsartan 80 mgDRUG

a single dose of valsartan

postmenopausal hypertensive women

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionHypertrophy, Left Ventricular

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCardiomegalyHeart DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 14, 2018

Study Start

April 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

March 13, 2018

Record last verified: 2018-01