Impact of In-centre Nocturnal Hemodialysis on Ventricular Remodeling and Function in End-stage Renal Disease
|ClinicalTrials.gov Identifier: NCT00718848|
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : October 14, 2015
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.
|Condition or disease||Intervention/treatment|
|End-stage Renal Disease Left Ventricular Hypertrophy||Procedure: Incentre nocturnal hemodialysis Procedure: Remaining on conventional hemodialysis|
|Study Type :||Observational|
|Actual Enrollment :||67 participants|
|Official Title:||Impact of In-centre Nocturnal Hemodialysis on Ventricular Remodeling and Function in End-stage Renal Disease|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
These are patients treated with conventional hemodialysis (4 hours/session, 3 sessions/week) who convert to incentre nocturnal hemodialysis (8 hours/session, 3 sessions/week).
Procedure: Incentre nocturnal hemodialysis
This is a hemodialysis schedule that consists of 3 weekly hemodialysis sessions administered overnight (8 hours/session) in-hospital.
These are patients treated with conventional hemodialysis (4 hours/session, 3 session/week) who elect to remain on this dialysis schedule and agree to the study-related investigations at baseline and one year thereafter.
Procedure: Remaining on conventional hemodialysis
These patients will remain on their current conventional hemodialysis schedule that consists of 4 hours/session, 3 sessions/week.
- change in left ventricular mass index [ Time Frame: 1 year ]
- changes in left ventricular volume and systolic function [ Time Frame: 12 months ]
- changes in regional left ventricular systolic and diastolic function [ Time Frame: 12 months ]
- changes in mineral metabolic parameters (calcium, phosphorus, parathyroid hormone) [ Time Frame: 12 months ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718848
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||Marc B. Goldstein, MD||St. Michael's Hospital, Toronto|
|Principal Investigator:||Andrew T Yan, MD||St. Michael's Hospital, Toronto|
|Principal Investigator:||Ron Wald, MD||St. Michael's Hospital, Toronto|