Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT00490958
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2007-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telmisartan in Haemodialysis Patients With Chronic Heart Failure
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': 'D000077333', 'term': 'Telmisartan'}], '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': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 351}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-16', 'studyFirstSubmitDate': '2007-06-22', 'studyFirstSubmitQcDate': '2007-06-22', 'lastUpdatePostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality cardiovascular mortality hospitalization for decompensated heart failure', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'acute non-fatal myocardial infarction', 'timeFrame': '36 months'}, {'measure': 'combined endpoint (cardiovascular mortality in addition to acute non-fatal myocardial infarction)', 'timeFrame': '36 months'}, {'measure': 'cardiovascular hospital admission', 'timeFrame': '36 months'}, {'measure': 'nonfatal stroke', 'timeFrame': '36 months'}, {'measure': 'coronary revascularization', 'timeFrame': '36 months'}, {'measure': 'permanent premature treatment withdrawals', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart Failure', 'haemodialysis', 'telmisartan', 'angiotensin converting enzyme inhibitor'], 'conditions': ['Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '21070920', 'type': 'DERIVED', 'citation': "Cice G, Di Benedetto A, D'Isa S, D'Andrea A, Marcelli D, Gatti E, Calabro R. Effects of telmisartan added to Angiotensin-converting enzyme inhibitors on mortality and morbidity in hemodialysis patients with chronic heart failure a double-blind, placebo-controlled trial. J Am Coll Cardiol. 2010 Nov 16;56(21):1701-8. doi: 10.1016/j.jacc.2010.03.105."}]}, 'descriptionModule': {'briefSummary': 'Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high mortality rate but, presently, very little data is available regarding this population.\n\nAim of the study: Aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with ACE inhibitors.\n\nMethods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5 months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult haemodialysis patients with CHF;\n* New York Heart Association (NYHA) class II and III;\n* Ejection fraction less or equal to 40% determined within 6 months; and\n* Therapy with ACE inhibitors individually optimized and unchanged for 30 days before randomization\n\nExclusion Criteria:\n\n* Hypotension during dialysis;\n* Atrial fibrillation;\n* Intolerant to low dose of telmisartan'}, 'identificationModule': {'nctId': 'NCT00490958', 'briefTitle': 'Telmisartan in Haemodialysis Patients With Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Effects Of Telmisartan Added To Angiotensin Converting Enzyme Inhibitors On Mortality And Morbidity In Haemodialysed Patients With Chronic Heart Failure: A Double-Blind Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'tchf-01-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'telmisartan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Naples', 'country': 'Italy', 'facility': 'Chair of Cardiology Second University of Naples', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Gennaro Cice, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chair of cardiology Second University of Naples'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}}}}