Impact of In-centre Nocturnal Hemodialysis on Ventricular Remodeling and Function in End-stage Renal Disease

October 13, 2015 updated by: Unity Health Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who convert to in-centre nocturnal hemodialysis and their matched controls will be drawn from a population of prevalent chronic hemodialysis patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
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.
2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in left ventricular mass index
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in left ventricular volume and systolic function
Time Frame: 12 months
12 months
changes in regional left ventricular systolic and diastolic function
Time Frame: 12 months
12 months
changes in mineral metabolic parameters (calcium, phosphorus, parathyroid hormone)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Marc B. Goldstein, MD, Unity Health Toronto
  • Principal Investigator: Andrew T Yan, MD, Unity Health Toronto
  • Principal Investigator: Ron Wald, MD, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 186223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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