Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT00602004
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2007-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}, {'id': 'D006984', 'term': 'Hypertrophy'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2007-03-08', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'left ventricular hypertrophy', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arteriovenous fistula', 'hypertrophy', 'losartan'], 'conditions': ['Renal Failure', 'Left Ventricular Hypertrophy']}, 'referencesModule': {'references': [{'pmid': '22642740', 'type': 'DERIVED', 'citation': 'Zentner D, Pedagogos E, Yapanis A, Karapanagiotidis S, Kinghorn A, Alexiou A, Lee G, Raspudic M, Aggarwal A. Can losartan and blood pressure control peri arteriovenous fistula creation ameliorate the early associated left ventricular hypertrophic response a randomised placebo controlled trial. BMC Res Notes. 2012 May 29;5:260. doi: 10.1186/1756-0500-5-260.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine if the use of losartan, an angiotensin II receptor blocker, can attenuate left ventricular hypertrophy, independent of its antihypertensive effects, in patients with near end stage chronic kidney disease (CKD) who have an arteriovenous fistula created.\n\nSecondary outcomes include the impact of the medication on BNP and hyperkalaemia', 'detailedDescription': "Study Design: This is a prospective double blind placebo control 2 arm, randomized (1:1) parallel group study in patients with near end stage renal failure who require creation of an arteriovenous fistula for future haemodialysis. Enrolment will be over a period of 12 months. The blinded phase will be for 3 months. The study design is summarized in Appendix 1. The study consists of a screening phase, a randomization phase and a treatment phase.\n\nPatients will be randomized into 2 groups:\n\n* Group 1 Losartan (50mg daily blinded) and 25 mg of atenolol\n* Group 2 Placebo (blinded) and 25 mg of atenolol\n\nPatients: Patients must comply with specified inclusion and exclusion criteria. The number of patients used will be sufficient to show a 15% difference in the left ventricular mass (LVM) between the two groups\n\nStudy Endpoints: The primary endpoint is the between group difference in LVM from baseline to 1 month.\n\nStatistical Considerations: The analysis will be based upon an 'ANCOVA'-type linear regression model that includes baseline LVM and treatment group as explanatory variables, and final LVM as the outcome variable."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of CKD at near-end stage renal failure (CKD Stage IV) ( eGFR = 15-30 mls/min).\n2. Age \\>18 years of age and \\<85 years of age.\n3. Males and post-menopausal, sterile women. Non-pregnant pre-menopausal women should be on adequate contraception and have no intention of becoming pregnant during the duration of the study.\n4. At baseline TTE LVEF\\>45%\n5. Willing and able to give informed consent.\n\nExclusion Criteria:\n\n1. Serum potassium level of more than 5.5 mmol/L\n2. Acute myocardial infarction or cerebrovascular accident in the previous 6 months.\n3. Severe uncontrolled hypertension (diastolic BP \\>100mmHg or systolic BP \\>160 mmHg)\n4. Evidence or suspicion of renovascular disease.\n5. Atrial fibrillation\n6. Evidence or suspicion of collagen disease, cancer, psychiatric disorder that interferes with patient compliance, drug or alcohol abuse, pregnancy, breast feeding and ineffective contraception.'}, 'identificationModule': {'nctId': 'NCT00602004', 'briefTitle': 'Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan', 'organization': {'class': 'OTHER', 'fullName': 'Melbourne Health'}, 'officialTitle': 'Early and Late Cardiac Effects of Arteriovenous Fistula Creation for Haemodialysis in End-stage Renal Failure and Their Possible Attenuation', 'orgStudyIdInfo': {'id': '2006.059'}}, 'armsInterventionsModule': {'interventions': [{'name': 'losartan', 'type': 'DRUG', 'description': 'losartan 50 mg a day'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3150', 'city': 'Parkville', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}], 'overallOfficials': [{'name': 'Anuradha Aggarwal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melbourne Health'}, {'name': 'Eugenia Pedagogos, FRACP,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Melbourne Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melbourne Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Anuradha Aggarwal', 'oldOrganization': 'Royal Melbourne Hospital'}}}}