Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-01 @ 11:19 AM
Study NCT ID:
NCT01028703
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular mass as measured by CMR and Echocardiography', 'timeFrame': '3 years'}, {'measure': 'Arterial stiffness as measured by pulse wave velocity', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Aortic compliance measured by cardiac magnetic resonance imaging', 'timeFrame': '3 years'}, {'measure': 'Left ventricular systolic and diastolic elastance measured by echocardiography;', 'timeFrame': '3 years'}, {'measure': 'Oxidative stress, inflammation and collagen turnover measured by blood assays of plasma renin, aldosterone, high sensitivity C-reactive protein (hsCRP), procollagen type III aminoterminal peptide (PIIINP) and C-telopeptide for type I collagen (CITP).', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'left ventricular dysfunction', 'diastolic dysfunction', 'hypertension'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '26754643', 'type': 'DERIVED', 'citation': 'Moody WE, Ferro CJ, Edwards NC, Chue CD, Lin EL, Taylor RJ, Cockwell P, Steeds RP, Townend JN; CRIB-Donor Study Investigators. Cardiovascular Effects of Unilateral Nephrectomy in Living Kidney Donors. Hypertension. 2016 Feb;67(2):368-77. doi: 10.1161/HYPERTENSIONAHA.115.06608.'}]}, 'descriptionModule': {'briefSummary': 'Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the arteries and heart.\n\nHypotheses. An isolated reduction in GFR occuring after surgical uni-nephrectomy is associated with long term adverse cardiac and vascular effects which include:\n\n1. Increased arterial stiffness and left ventricular mass\n2. Abnormalities in left ventricular systolic and diastolic function\n3. Increased oxidative stress, inflammation and collagen turnover'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Renal outpatient clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Potential kidney donor attending University Hospital Birmingham NHS Foundation Trust\n\nCurrent nationally set Exclusion Criteria:\n\n* Diabetes mellitus\n* Atrial fibrillation\n* Left ventricular dysfunction (ejection fraction \\<40% on transthoracic echocardiography)\n* History of cardiovascular or pulmonary disease\n* Evidence of hypertensive end-organ damage.'}, 'identificationModule': {'nctId': 'NCT01028703', 'briefTitle': 'Effects of a Reduction in Kidney Function on Cardiovascular Structure and Function: A Prospective Study of Kidney Donors', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Birmingham NHS Foundation Trust'}, 'officialTitle': 'Does a Reduction in Renal Function Increase Arterial Stiffness and Left Ventricular Mass? - A Prospective Study of Kidney Donors', 'orgStudyIdInfo': {'id': 'RKK3922'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Donors', 'description': '110 will be "cases" that undergo uninephrectomy'}, {'label': 'Controls', 'description': '110 "controls"'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'University Hospital Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Jonathan N Townend', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy Hospital Birmingham NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Birmingham NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BHF Clinical Research Fellow', 'investigatorFullName': 'William E Moody', 'investigatorAffiliation': 'University Hospital Birmingham NHS Foundation Trust'}}}}