Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-28 @ 3:57 PM
Study NCT ID:
NCT01330004
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2011-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Pressure Change and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12695}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2011-03-31', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect size of the relation of dynamic changes of blood pressure (BP) at different ranges of BP to survival in incident hemodialysis patients.', 'timeFrame': 'Up to 11 years and 11 months', 'description': 'The ranges of blood pressure measurements in mmHg over time and the relation to patient outcomes (including survival)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Disease', 'High Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '22217879', 'type': 'DERIVED', 'citation': 'Raimann JG, Usvyat LA, Thijssen S, Kotanko P, Rogus J, Lacson E Jr, Levin NW. Blood pressure stability in hemodialysis patients confers a survival advantage: results from a large retrospective cohort study. Kidney Int. 2012 Mar;81(6):548-58. doi: 10.1038/ki.2011.426. Epub 2012 Jan 4.'}]}, 'descriptionModule': {'briefSummary': 'Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal disease) population. In dialysis patients, however, it has been shown that higher blood pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure evolution over time has not been previously studied in dialysis population. The investigators aim to understand how both blood pressure levels and blood pressure changes over time predict patient survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Renal Research Institute hemodialysis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemodialysis'}, 'identificationModule': {'nctId': 'NCT01330004', 'acronym': 'BP', 'briefTitle': 'Blood Pressure Change and Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Renal Research Institute'}, 'officialTitle': 'The Relationship of Systolic and Diastolic Blood Pressure Changes Over Time to Patient Outcomes in Incident Hemodialysis Patients', 'orgStudyIdInfo': {'id': '080-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemodialysis patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Renal Research Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Nathan W Levin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renal Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Renal Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}