Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-31 @ 9:47 AM
Study NCT ID:
NCT01579032
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2012-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CKD,'], 'conditions': ['Arterial Stiffness', 'CHRONIC RENAL FAILURE', 'Left Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': 'The aims of the presented study are as follows:\n\n1. To evaluate the endothelial function and arterial stiffness in a large cohort of prevalent CKD patients by means of non-invasive applantion tonometry.\n2. To evaluate the association between the serum levels of the representatives of the various classes of uremic toxins and markers of endothelial function and arterial stiffness.\n3. To evaluate the association between markers of inflammation and oxidative stress and markers of endothelial function and arterial stiffness.\n4. To evaluate the association between echocardiographic parameters and markers of arterial stiffness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CKD patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-60\n* Chronic kidney disease: according to the K-DOQI guidelines ( kidney damage ≥ three months, as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifest by either: pathological abnormalities; or markers of kidney damage, including damage in the composition of blood or urine test, or abnormalities in imaging tests; GFR\\< 60 ml/min/1.73m² for ≥ three months, with or without kidney damage)\n* Written informed consent\n\nExclusion Criteria:\n\n* major illnesses( life expectancy of \\< 1 year)\n* history of atrial fibrillation\n* history of myocardial infarction, unstable angina, congestive heart failure, peripheral vascular diasease ,cerebrovascular disease, diabetes\n\n(nonechogenic)'}, 'identificationModule': {'nctId': 'NCT01579032', 'briefTitle': 'Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.', 'orgStudyIdInfo': {'id': 'ML2863'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}