Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451747
Recruitment Status : Unknown
Verified January 2018 by Jing Yu, LanZhou University.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jing Yu, LanZhou University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Hypertension

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 322 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Potential Role of Testosterone Between Hypertension and Target Organ Damage in Postmenopausal Hypertensive Women
Estimated Study Start Date : March 10, 2018
Estimated Primary Completion Date : April 5, 2018
Estimated Study Completion Date : April 5, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
postmenopausal hypertensive women
mached hypertensive men


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Relative indexes of myocardial remodeling [ Time Frame: Baseline ]
    Cardiac structure (left ventricular mass index in grams for square meter) measurement.

  2. Ambulatory blood pressure monitoring [ Time Frame: Baseline ]
    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.

  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jing Yu, Principal Investigator, LanZhou University
ClinicalTrials.gov Identifier: NCT03451747    
Other Study ID Numbers: LanZhou
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jing Yu, LanZhou University:
hypertension
female
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases