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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Valsartan 1
Valsartan 80 mg
Sponsored by
LanZhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Left Ventricular Hypertrophy, Women

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    postmenopausal hypertensive women

    age-matched hypertensive male patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    Relative indexes of myocardial remodeling
    Cardiac structure (left ventricular mass index in grams for square meter) measurement.
    Relative indexes of myocardial remodeling
    Cardiac structure (left ventricular mass index in grams for square meter) measurement.
    Ambulatory blood pressure monitoring
    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
    Ambulatory blood pressure monitoring
    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2018
    Last Updated
    March 10, 2018
    Sponsor
    LanZhou University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03432468
    Brief Title
    Effect of Fully Blocking Type 1 Angiotensin Receptor on Target Organ Damage of Postmenopausal Hypertensive Women
    Official Title
    Effect of Fully Blocking Type 1 Angiotensin Receptor on Blood Pressure, Cardiac Structure, Cardiac Function and Cognitive Function in Postmenopausal Hypertensive Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    August 1, 2019 (Anticipated)
    Study Completion Date
    August 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    LanZhou University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    Hypertension, Left Ventricular Hypertrophy, Women

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    postmenopausal hypertensive women
    Arm Type
    Active Comparator
    Arm Title
    age-matched hypertensive male patients
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Valsartan 1
    Intervention Description
    the high dose of valsartan
    Intervention Type
    Drug
    Intervention Name(s)
    Valsartan 80 mg
    Intervention Description
    a single dose of valsartan
    Primary Outcome Measure Information:
    Title
    Relative indexes of myocardial remodeling
    Description
    Cardiac structure (left ventricular mass index in grams for square meter) measurement.
    Time Frame
    Change from Baseline left ventricular mass index at 6 months.
    Title
    Relative indexes of myocardial remodeling
    Description
    Cardiac structure (left ventricular mass index in grams for square meter) measurement.
    Time Frame
    Change from Baseline left ventricular mass index at 12 months.
    Title
    Ambulatory blood pressure monitoring
    Description
    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
    Time Frame
    Change from Baseline ABPM at 6 months.
    Title
    Ambulatory blood pressure monitoring
    Description
    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.
    Time Frame
    Change from Baseline ABPM at 12 months.
    Title
    Sexual hormones
    Description
    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.
    Time Frame
    Baseline sexual hormones.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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