Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00277693
Status:
UNKNOWN
Last Update Posted:
2006-01-16
First Post:
2006-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Protective Effect of Spironolactone in Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'lastUpdateSubmitDate': '2006-01-12', 'studyFirstSubmitDate': '2006-01-12', 'studyFirstSubmitQcDate': '2006-01-12', 'lastUpdatePostDateStruct': {'date': '2006-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['hemodialysis', 'aldosterone', 'heart failure', 'spironolactone'], 'conditions': ['Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '15458462', 'type': 'BACKGROUND', 'citation': 'Michea L, Vukusich A, Gonzalez M, Zehnder C, Marusic ET. Effect of spironolactone on K(+) homeostasis and ENaC expression in lymphocytes from chronic hemodialysis patients. Kidney Int. 2004 Oct;66(4):1647-53. doi: 10.1111/j.1523-1755.2004.00931.x.'}, {'pmid': '33586138', 'type': 'DERIVED', 'citation': 'Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to determine if spironolactone is safe and effective in the treatment of cardiovascular complications in hemodialysis patients.', 'detailedDescription': 'Cardiovascular complications are common in dialysis patients and comprise up to 50% of deaths in end-stage renal disease population. Hypertension and left ventricle hypertrophy occur in more than 70% of patients undergoing long-term hemodialysis therapy, and both contributes to mortality and morbidity.Recent clinical trials in chronic heart failure and post miocardial infarct heart failure patients have demonstrated a beneficial effect of a mineralocorticoid receptor blocker spironolactone, in adittion to standard therapy (RALES AND EPHESUS studies). The aim of the present study is to evaluate spironolactone treatment in hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\nchronic hemodialysys (\\> 3 months) anuria (diuresis \\<200 mL/day) -\n\nExclusion Criteria:\n\nLiver failure Insulin dependent diabetes Treatment with adrenergic beta blockers or agonists Treatment with converting-enzime blocker or angiotensin receptor antagonists Cancer\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00277693', 'briefTitle': 'Cardiovascular Protective Effect of Spironolactone in Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de los Andes, Chile'}, 'officialTitle': 'Protective Mechanisms of Aldosterone Antagonists and Their Effects on Cardiovascular Damage in Chronic Renal Failure: Clinical and Experimental Studies', 'orgStudyIdInfo': {'id': '1040338'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spironolactone (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Antonio Vukusich, MD', 'role': 'CONTACT', 'email': 'avukusic@davila.cl', 'phone': '56-2-7308021'}, {'name': 'Elisa T Marusic, PhD', 'role': 'CONTACT', 'email': 'emarusic@uandes.cl', 'phone': '56-2-4129341'}, {'name': 'Antonio Vukusich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica Davila', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Antonio Vukusich, MD', 'role': 'CONTACT', 'email': 'avukusic@davila.cl', 'phone': '56-2-7308021'}], 'overallOfficials': [{'name': 'Luis F Michea, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, University Los Andes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de los Andes, Chile', 'class': 'OTHER'}}}}