Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-02 @ 2:47 AM
Study NCT ID:
NCT01152892
Status:
UNKNOWN
Last Update Posted:
2016-01-26
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2010-06-28', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality of all causes', 'timeFrame': '24 months', 'description': '24 month follow up'}], 'secondaryOutcomes': [{'measure': 'Incidence of cardiovascular events', 'timeFrame': '24 months', 'description': '24 month follow up'}, {'measure': 'Blood pressure drops within a dialysis session', 'timeFrame': '24 months', 'description': '24 month follow up'}, {'measure': 'Incidence of infections requiring antibiotic treatment', 'timeFrame': '24 months', 'description': '24 month follow up'}, {'measure': 'Incidence of shunt thrombosis', 'timeFrame': '24 months', 'description': '24 month follow up'}, {'measure': 'incidence of death and hospitalization due to infection', 'timeFrame': '24 months', 'description': '24 month follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['end stage renal disease', 'chronic kidney disease', 'cardiovascular event', 'sudden cardiac death', 'autonomic function'], 'conditions': ['End Stage Renal Disease', 'Chronic Kidney Disease', 'Cardiovascular Event', 'Sudden Cardiac Death']}, 'referencesModule': {'references': [{'pmid': '16714188', 'type': 'BACKGROUND', 'citation': 'Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81. doi: 10.1016/S0140-6736(06)68735-7.'}, {'pmid': '33576412', 'type': 'DERIVED', 'citation': 'Werfel S, Gunthner R, Hapfelmeier A, Hanssen H, Kotliar K, Heemann U, Schmaderer C. Identification of cardiovascular high-risk groups from dynamic retinal vessel signals using untargeted machine learning. Cardiovasc Res. 2022 Jan 29;118(2):612-621. doi: 10.1093/cvr/cvab040.'}, {'pmid': '30929571', 'type': 'DERIVED', 'citation': 'Gunthner R, Hanssen H, Hauser C, Angermann S, Lorenz G, Kemmner S, Matschkal J, Braunisch MC, Kuechle C, Renders L, Moog P, Wassertheurer S, Baumann M, Hammes HP, Mayer CC, Haller B, Stryeck S, Madl T, Carbajo-Lozoya J, Heemann U, Kotliar K, Schmaderer C. Impaired Retinal Vessel Dilation Predicts Mortality in End-Stage Renal Disease. Circ Res. 2019 Apr 1. doi: 10.1161/CIRCRESAHA.118.314318. Online ahead of print.'}, {'pmid': '27941217', 'type': 'DERIVED', 'citation': 'Hagmair S, Braunisch MC, Bachler M, Schmaderer C, Hasenau AL, Bauer A, Rizas KD, Wassertheurer S, Mayer CC. Implementation and verification of an enhanced algorithm for the automatic computation of RR-interval series derived from 24 h 12-lead ECGs. Physiol Meas. 2017 Jan;38(1):1-14. doi: 10.1088/1361-6579/38/1/1. Epub 2016 Dec 12.'}, {'pmid': '27784272', 'type': 'DERIVED', 'citation': 'Schmaderer C, Tholen S, Hasenau AL, Hauser C, Suttmann Y, Wassertheurer S, Mayer CC, Bauer A, Rizas KD, Kemmner S, Kotliar K, Haller B, Mann J, Renders L, Heemann U, Baumann M. Rationale and study design of the prospective, longitudinal, observational cohort study "rISk strAtification in end-stage renal disease" (ISAR) study. BMC Nephrol. 2016 Oct 26;17(1):161. doi: 10.1186/s12882-016-0374-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with end stage renal disease treated with chronic hemodialysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older\n2. End-stage renal disease (ESRD) and receiving maintenance hemodialysis\n\nExclusion Criteria:\n\n1. Any clinically significant infection.\n2. pregnancy\n3. history of malignant disease with a prognostic life expectancy less than 24 months\n4. missing of written and informed consent'}, 'identificationModule': {'nctId': 'NCT01152892', 'acronym': 'ISAR', 'briefTitle': 'Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Risk Stratification in End Stage Renal Disease (ISAR)', 'orgStudyIdInfo': {'id': 'ISAR ESRD 01 2010'}}, 'contactsLocationsModule': {'locations': [{'zip': '84503', 'city': 'Altötting', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center', 'geoPoint': {'lat': 48.22533, 'lon': 12.67665}}, {'zip': '89407', 'city': 'Dillingen an der Donau', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center Dillingen', 'geoPoint': {'lat': 48.58153, 'lon': 10.49527}}, {'zip': '84130', 'city': 'Dingolfing', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Praxen Dr. Braun Dingolfing', 'geoPoint': {'lat': 48.64244, 'lon': 12.49283}}, {'zip': '80687', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center Elsenheimerstrasse', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '80804', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center Munich Schwabing', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81545', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center Munich Harlaching', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '82061', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center Neuried', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '80807', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Dialysezentrum München Nord', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81479', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Dialysezentrum München Solln', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81539', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Nierenzentrum Giesinger Bahnhof', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of nephrology, Klinikum rechts der Isar', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81737', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Nierenzentrum Perlach', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81925', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Nierenzentrum Bogenhausen', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '85764', 'city': 'Oberschleißheim', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center Oberschleißheim', 'geoPoint': {'lat': 48.25, 'lon': 11.56667}}, {'zip': '82008', 'city': 'Unterhaching', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center Unterhaching', 'geoPoint': {'lat': 48.06598, 'lon': 11.61564}}, {'zip': '80804', 'city': 'Weißenburg in Bayern', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KFH Dialysis Center Weißenburg', 'geoPoint': {'lat': 49.03095, 'lon': 10.97221}}, {'zip': '80337', 'city': 'München', 'country': 'Germany', 'facility': 'Dialyse im Zentrum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Christoph Schmaderer, M.D., PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'study chief investigator and head of the nephrological laboratory at the department of nephrology of the Klinikum rechts der Isar of the Technical University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Else Kröner Fresenius Foundation', 'class': 'OTHER'}, {'name': 'AIT Austrian Institute of Technology GmbH', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'FH Aachen, University of applied sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Christoph Schmaderer', 'investigatorFullName': 'PD Dr. Christoph Schmaderer', 'investigatorAffiliation': 'Technical University of Munich'}}}}