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

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ClinicalTrials.gov Identifier: NCT03432468
Recruitment Status : Unknown
Verified January 2018 by Jing Yu, LanZhou University.
Recruitment status was:  Not yet recruiting
First Posted : February 14, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jing Yu, LanZhou University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan 1 Drug: Valsartan 80 mg Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Fully Blocking Type 1 Angiotensin Receptor on Blood Pressure, Cardiac Structure, Cardiac Function and Cognitive Function in Postmenopausal Hypertensive Women
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: postmenopausal hypertensive women Drug: Valsartan 1
the high dose of valsartan

Drug: Valsartan 80 mg
a single dose of valsartan
Placebo Comparator: age-matched hypertensive male patients Drug: Valsartan 1
the high dose of valsartan


Outcome Measures
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Primary Outcome Measures :
  1. Relative indexes of myocardial remodeling [ Time Frame: Change from Baseline left ventricular mass index at 6 months. ]
    Cardiac structure (left ventricular mass index in grams for square meter) measurement.

  2. Relative indexes of myocardial remodeling [ Time Frame: Change from Baseline left ventricular mass index at 12 months. ]
    Cardiac structure (left ventricular mass index in grams for square meter) measurement.

  3. Ambulatory blood pressure monitoring [ Time Frame: Change from Baseline ABPM at 6 months. ]
    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.

  4. Ambulatory blood pressure monitoring [ Time Frame: Change from Baseline ABPM at 12 months. ]
    Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.

  5. Sexual hormones [ Time Frame: Baseline 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jing Yu, Principal Investigator, LanZhou University
ClinicalTrials.gov Identifier: NCT03432468    
Other Study ID Numbers: LanZhouU
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Left Ventricular Hypertrophy
Women
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action