Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-08 @ 9:41 PM
Study NCT ID:
NCT00659451
Status:
UNKNOWN
Last Update Posted:
2008-04-16
First Post:
2008-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of Losartan On Myocardial Structure In Diabetic Hypertensive Patients With Left Ventricular
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-14', 'studyFirstSubmitDate': '2008-04-14', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular mass, intraventricular septal thickness, fractional shortening; myocardial qualitative and diastolic function alteration; aortic strain and distensibility.', 'timeFrame': 'Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months'}], 'secondaryOutcomes': [{'measure': 'Heterogeneity of myocardial tissue; epicardial adipose tissue measurement', 'timeFrame': 'Between 08.00 and 10.00 at baseline, and after 3, 6, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Diabetes mellitus', 'Heart'], 'conditions': ['Essential Hypertension', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The anthypertensive treatment with Losartan may have benefits beyond blood pressure reduction on myocardial structure and function in hypertensive diabetic patients. We will evaluate the effect of losartan treatment on structural characteristics of myocardium in hypertensive diabetic patients:\n\n1. left ventricular mass, intraventricular septal thickness, fractional shortening.\n2. myocardial qualitative alteration and heterogeneity of myocardial tissue that describes myocardial texture and echodensity, related to collagen deposition; myocardial qualitative alteration will be evaluate by ultrasonic myocardial integrated backscatter signals (IBS) both as peak end diastolic signal intensity and as cardiac cyclic variation\n3. alteration of diastolic function as studied by Doppler flow velocities across the mitral valve (Pulse Wave Doppler) and pulse wave Tissue Doppler Imaging parameters\n4. aortic strain and distensibility (that is in relation with LVH)\n5. epicardial adipose tissue measurement (this parameter is related to the visceral fat and may be an easy method to indicate patients with high cardiovascular risk).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gender: 50% Male and 50 % female\n* Age: 40-80 years\n* Race: caucasian\n* Well controlled type II Diabetes : fasting glicemia \\< 126 mg/dl in two different determinantion or any non fasting glicemia \\> 200 mg/dl; HbA1c \\< 7%\n* Mild to moderate hypertension (BP\\>130/80mmHg; \\<160/100mmHg)\n* Left ventricular hypertrophy (LVMI \\> 131/110 g/m2 in males/females respectively)\n\nExclusion Criteria:\n\n* other anthypertensive treatment after wash out period of 2 weeks\n* abnormal heart rest function (EF \\< 55%).\n* valvular heart disease\n* congenital heart disease\n* heart failure or prior myocardial infarction\n* renal disease\n* liver disease\n* connective tissue disease\n* pregnancy or lactation\n* sensitivity to the study drugs\n* contraindication from an approved label'}, 'identificationModule': {'nctId': 'NCT00659451', 'briefTitle': 'Effects Of Losartan On Myocardial Structure In Diabetic Hypertensive Patients With Left Ventricular', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Effects Of Losartan On Myocardial Structure And Function And On Epicardial Fat Deposition In Diabetic Hypertensive Patients With Left Ventricular: Qualitative And Quantitative Alteration', 'orgStudyIdInfo': {'id': 'UNIPV002DIM2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Losartan', 'interventionNames': ['Drug: Losartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Amlodipine', 'interventionNames': ['Drug: Amlodipine']}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'description': 'tablets; 50, 100 mg; od; 12 months', 'armGroupLabels': ['2']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'tablets; 5, 10 mg; od; 12 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paola Preti, MD', 'role': 'CONTACT', 'phone': '+39 0382 526217'}, {'name': 'Paola Preti', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Roberto Fogari', 'role': 'CONTACT', 'phone': '+39 0382 526217'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Paola Preti/MD', 'oldOrganization': 'University of Pavia'}}}}