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Clinical Trials/NCT00925483
NCT00925483
Unknown
Not Applicable

Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Dallas VA Medical Center1 site in 1 country60 target enrollmentAugust 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
Dallas VA Medical Center
Enrollment
60
Locations
1
Primary Endpoint
LVM change per Cardiac MRI
Last Updated
16 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2004
End Date
December 2012
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

LVM change per Cardiac MRI

Time Frame: 6 months

Study Sites (1)

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