The Potential Role of Testosterone on Target Organ Damage in Postmenopausal Hypertensive Women

March 1, 2018 updated by: Jing Yu, LanZhou University

The Potential Role of Testosterone Between Hypertension and Target Organ Damage in Postmenopausal Hypertensive Women

The incidence of CVD-related deaths is generally higher in women than men. Postmenopausal changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed as important factors in the higher prevalence of hypertension. Therefore, the investigators hypothesize that testosterone has potential role between hypertension and target organ damage in postmenopausal hypertensive women. And the objective is to evaluate the effects of testosterone between hypertension and target organ damage in postmenopausal hypertensive women.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 322 hypertensive patients hospitalized in our department from 2016 to 2017 were enrolled. Included 161 postmenopausal hypertensive women and 161 mached hypertensive men.

Description

Inclusion Criteria:

  • Clinical diagnosis of hypertension
  • Women are all postmenopausal
  • Men are matched with women.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
postmenopausal hypertensive women
mached hypertensive men

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative indexes of myocardial remodeling
Time Frame: Baseline
Cardiac structure (left ventricular mass index in grams for square meter) measurement.
Baseline
Ambulatory blood pressure monitoring
Time Frame: Baseline
Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
Baseline
The level of testosterone (T)
Time Frame: Baseline
Blood samples used to analyze the levels of sexual hormones were collected between morning 8:00 and 9:00 after an overnight fast. Testosterone (T) units on nanogram per deciliter.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LanZhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 10, 2018

Primary Completion (Anticipated)

April 5, 2018

Study Completion (Anticipated)

April 5, 2018

Study Registration Dates

First Submitted

February 18, 2018

First Submitted That Met QC Criteria

February 24, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LanZhou

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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