Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT03432468
Status:
UNKNOWN
Last Update Posted:
2018-03-13
First Post:
2018-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fully Blocking Type 1 Angiotensin Receptor on Target Organ Damage of Postmenopausal Hypertensive Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-10', 'studyFirstSubmitDate': '2018-01-19', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative indexes of myocardial remodeling', 'timeFrame': 'Change from Baseline left ventricular mass index at 6 months.', 'description': 'Cardiac structure (left ventricular mass index in grams for square meter) measurement.'}, {'measure': 'Relative indexes of myocardial remodeling', 'timeFrame': 'Change from Baseline left ventricular mass index at 12 months.', 'description': 'Cardiac structure (left ventricular mass index in grams for square meter) measurement.'}, {'measure': 'Ambulatory blood pressure monitoring', 'timeFrame': 'Change from Baseline ABPM at 6 months.', 'description': 'Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.'}, {'measure': 'Ambulatory blood pressure monitoring', 'timeFrame': 'Change from Baseline ABPM at 12 months.', 'description': 'Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment.'}, {'measure': 'Sexual hormones', 'timeFrame': 'Baseline 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Left Ventricular Hypertrophy', 'Women'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of hypertension\n* Women are all postmenopausal\n* Must provide written informed consent\n\nExclusion Criteria:\n\n* Secondary hypertension\n* Coronary disease\n* Heart failure\n* Arterial fibrillation\n* Previous myocardial infarction\n* Previous stroke\n* Malignant disease\n* Kidney failure\n* Liver failure\n* Neoplastic disease\n* Severe neurological diseases\n* Severe metabolic or organic decompensation\n* Refuse to sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT03432468', 'briefTitle': 'Effect of Fully Blocking Type 1 Angiotensin Receptor on Target Organ Damage of Postmenopausal Hypertensive Women', 'organization': {'class': 'OTHER', 'fullName': 'LanZhou University'}, 'officialTitle': 'Effect of Fully Blocking Type 1 Angiotensin Receptor on Blood Pressure, Cardiac Structure, Cardiac Function and Cognitive Function in Postmenopausal Hypertensive Women', 'orgStudyIdInfo': {'id': 'LanZhouU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'postmenopausal hypertensive women', 'interventionNames': ['Drug: Valsartan 1', 'Drug: Valsartan 80 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'age-matched hypertensive male patients', 'interventionNames': ['Drug: Valsartan 1']}], 'interventions': [{'name': 'Valsartan 1', 'type': 'DRUG', 'description': 'the high dose of valsartan', 'armGroupLabels': ['age-matched hypertensive male patients', 'postmenopausal hypertensive women']}, {'name': 'Valsartan 80 mg', 'type': 'DRUG', 'description': 'a single dose of valsartan', 'armGroupLabels': ['postmenopausal hypertensive women']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LanZhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jing Yu', 'investigatorAffiliation': 'LanZhou University'}}}}