Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Study Overview
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Brief Summary
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Given the known increased risk of heart disease in hemodialysis patients, this study aims to evaluate the change in both size and function of the heart by using cardiac magnetic resonance imaging (MRI) in patients undergoing either daily long (4 hours, 6 times weekly), daily short (2 hours 6 times weekly), or alternate day conventional (4 hours, 3 times weekly) and alternate day long (8 hours, 3 times weekly) dialysis for 6 months from randomization. The patients are randomly put in the groups based on predetermined randomization schedule and the cardiologist trained in cardiac MRI readings is blinded to the patient treatment schedule. Given that changes in heart function may be seen with cardiac imaging techniques within 6 months, the expectation is that groups on daily treatment may have better outcome for this parameter as changes in volume and blood pressure may also be affected in a positive way in patients on daily dialysis.

Official Title
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Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Procedure: dialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End stage renal disease patients on hemodialysis Exclusion Criteria: Weight > 350 lbs Known poor dialysis and or treatment compliance Unable to come for daily treatments if randomization occurs in this group Prognosis less than 6 months Difficulty in tolerating dialysis and possibility of discontinuation of dialysis before 6 months

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: daily long<br>daily long (4 hours, 6 times weekly) dialysis for 6 months | Procedure: dialysis<br>* different dialysis schedules for each arm<br>|
| Experimental: daily short<br>daily short (2 hours 6 times weekly) dialysis for 6 months | Procedure: dialysis<br>* different dialysis schedules for each arm<br>|
| Experimental: alternate day conventional<br>alternate day conventional (4 hours, 3 times weekly) dialysis for 6 months | Procedure: dialysis<br>* different dialysis schedules for each arm<br>|
| Experimental: alternate day long<br>alternate day long (8 hours, 3 times weekly) dialysis for 6 months | Procedure: dialysis<br>* different dialysis schedules for each arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVM change per Cardiac MRI |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left ventricular mass, cardiac MRI, long dialysis, daily dialysis