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Trial NCT00718848

Resource URI: http://static.linkedct.org/resource/trials/NCT00718848
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/11604>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/22548>
linkedct:biospec Serum and plasma.
linkedct:biospec_retention Samples Without DNA
linkedct:brief_title Impact of In-centre Nocturnal Hemodialysis on Ventricular Remodeling and Function in End-stage Renal Disease
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/4375>
linkedct:condition <http://static.linkedct.org/resource/condition/7167>
linkedct:criteria Inclusion Criteria: - adult patients currently treated with conventional hemodialysis for > 6 months Exclusion Criteria: - acute coronary syndrome or coronary revascularization (percutaneous coronary intervention, coronary bypass surgery) within the past 6 months - uncontrolled hypertension (systolic blood pressure > 200 mmHg, or diastolic blood pressure > 120 mmHg) - severe heart failure (New York Heart Association functional class IV) - chronic atrial fibrillation - serious co-morbidity (e.g. cancer) with a life expectancy of less than 1 year - pregnancy - patient refusal to undergo baseline CMR - contraindications to CMR (e.g. pacemaker, implantable cardiac defibrillator) - inability to provide informed consent
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:eligibility_sampling_method Non-Probability Sample
linkedct:eligibility_study_pop The patients who convert to in-centre nocturnal hemodialysis and their matched controls will be drawn from a population of prevalent chronic hemodialysis patients.
linkedct:end_date July 2011
linkedct:enrollment 70 (xsd:int)
linkedct:firstreceived_date July 18, 2008
linkedct:has_dmc No
linkedct:id NCT00718848
linkedct:intervention <http://static.linkedct.org/resource/intervention/110541>
linkedct:intervention <http://static.linkedct.org/resource/intervention/89920>
rdfs:label Trial NCT00718848
linkedct:lastchanged_date August 13, 2009
linkedct:lead_sponsor_agency St. Michael's Hospital, Toronto
linkedct:location <http://static.linkedct.org/resource/location/20308>
linkedct:nct_id NCT00718848
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 2 (xsd:int)
linkedct:official_title Impact of In-centre Nocturnal Hemodialysis on Ventricular Remodeling and Function in End-stage Renal Disease
linkedct:org_study_id 186223
linkedct:overall_contact_email waldr@smh.toronto.on.ca
linkedct:overall_contact_last_name Ron Wald, MD
linkedct:overall_contact_phone 416-867-3703
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/2880>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/36959>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/51726>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/402>
linkedct:oversight <http://static.linkedct.org/resource/oversight/410>
foaf:page <http://clinicaltrials.gov/show/NCT00718848>
linkedct:phase N/A
linkedct:primary_completion_date July 2011
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/27948>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/16013>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/16027>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/16048>
linkedct:source St. Michael's Hospital, Toronto
linkedct:start_date July 2008
linkedct:study_design Cohort, Prospective
linkedct:study_type Observational
linkedct:summary Background: Recent data indicate that home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6 nights per week) may have substantial cardiovascular benefits, including regression of left ventricular (LV) hypertrophy, improved LV ejection fraction and blood pressure control. Nevertheless, this dialysis modality is only feasible in a highly-selected minority of ESRD patients, who can self-manage their dialysis treatment at home. In-centre nocturnal hemodialysis (INHD), administered as 7-8 hours of hemodialysis in hospital for 3 nights per week, represents an appealing and practical alternative. As this is a novel form of therapy, there has been no definitive study examining the cardiovascular impact of INHD to date. Objective: To determine the effects of INHD on LV mass, global and regional systolic and diastolic function, and other cardiovascular biomarkers in patients with ESRD. Hypothesis: Conversion from conventional hemodialysis to INHD is associated with favourable changes in cardiac structure and function in patients with ESRD. Rationale for Using Cardiac MRI: Cardiac magnetic resonance imaging (CMR) has emerged as the new gold standard for measuring LV mass, volume, global and regional myocardial function. Its accuracy and precision make it the imaging modality of choice for studying the small number of patients currently undergoing or awaiting INHD. Study Design and Population: This is a prospective cohort study of adult ESRD patients who are currently receiving conventional in-centre hemodialysis and will be converted to INHD. Patients will be managed as per standard clinical practice (e.g. blood pressure, anemia management) established for the INHD program, and no therapeutic intervention will be performed as part of this study. All eligible patients will undergo two serial CMR examinations: within 2 weeks prior to conversion and at 52 weeks following conversion to INHD. We also plan to recruit a population of control patients who have elected to remain on conventional HD. These individuals will be asked to undergo the same set of investigations at baseline and 12 months thereafter. Outcome: The primary endpoints are the temporal changes in LV mass and size, global and regional diastolic and systolic function at 52 weeks after conversion to INHD, as measured by cardiac MRI. Secondary endpoints include changes in myocardial tissue characteristics, blood pressure, mineral metabolic parameters, anemia control, serum troponin, norepinephrine, brain natriuretic peptide, markers of inflammation and quality of life. Significance: The provision of an enhanced dialysis regimen has emerged as the most promising avenue through which to modify the dismal cardiovascular outcomes in patients receiving chronic hemodialysis. INHD represents a means of administering such therapy to a broad spectrum of dialysis patients for whom home therapies would not be feasible. The proposed study will be the first to precisely define the cardiac impact of INHD using CMR. The findings may justify large randomized controlled trials evaluating clinical outcomes. If INHD is proven to be effective, it will have a major impact on the management and outcome of many patients with ESRD in Canada.
rdf:type linkedct:trials
linkedct:verification_date August 2009