Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT01670903
Status:
UNKNOWN
Last Update Posted:
2012-08-22
First Post:
2012-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-19', 'studyFirstSubmitDate': '2012-08-19', 'studyFirstSubmitQcDate': '2012-08-19', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aneurysm', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the aortic wall. The natural history of AAA is gradual expansion and if left untreated may result in rupture and death. The mechanism of the development of this disease is unknown however it appears to be multifactorial and possibly related to degradation processes within the arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may have an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting degeneration of the vessel wall.\n\nStudy hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive patients, and are associated with a lower rate of aortic expansion compared to other antihypertensive drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'medically treated hypertensive patients, ages 50-80', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medically treated hypertensive patients, ages 50-80\n\nExclusion Criteria:\n\n* pregnant women\n* patients previously treated for aortic disease\n* unable to sign informed consent, minors'}, 'identificationModule': {'nctId': 'NCT01670903', 'briefTitle': 'The Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'the Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients', 'orgStudyIdInfo': {'id': 'SHEBA-12-8336-DS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARBs', 'description': 'Hypertensive patients treated with ARBs'}, {'label': 'ACE inhibitors', 'description': 'Hypertensive patients treated with ACE inhibitors'}, {'label': 'non ARB/ACE', 'description': 'Hypertensive patients treated with non ARBs or ACE inhibitors meds'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jacob Schneiderman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ehud Grossman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Moshe Halak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anan Younes, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dmitry Yakubovitz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bashir Sheik-yosef, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ronnie E Reinitz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Daniel Silverberg, MD', 'role': 'CONTACT', 'email': 'Daniel.Silverberg@sheba.health.gov.il'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Daniel Silverberg, MD', 'role': 'CONTACT', 'email': 'Daniel.Silverberg@sheba.health.gov.il', 'phone': '035302712'}], 'overallOfficials': [{'name': 'Daniel Silverberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant - Vascular surgery', 'investigatorFullName': 'Dr. Daniel Silverberg', 'investigatorAffiliation': 'Sheba Medical Center'}}}}