Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFebruary 25, 2010
February 1, 2010
8.3 years
June 19, 2009
February 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LVM change per Cardiac MRI
6 months
Study Arms (4)
daily long
EXPERIMENTALdaily long (4 hours, 6 times weekly) dialysis for 6 months
daily short
EXPERIMENTALdaily short (2 hours 6 times weekly) dialysis for 6 months
alternate day conventional
EXPERIMENTALalternate day conventional (4 hours, 3 times weekly) dialysis for 6 months
alternate day long
EXPERIMENTALalternate day long (8 hours, 3 times weekly) dialysis for 6 months
Interventions
different dialysis schedules for each arm
Eligibility Criteria
You may qualify if:
- End stage renal disease patients on hemodialysis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dallas VA Medical Center
Dallas, Texas, 75216, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Devasmita C. Dev, MD
VA North Texas Health Care System, Dallas VA Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
June 19, 2009
First Posted
June 22, 2009
Study Start
August 1, 2004
Primary Completion
December 1, 2012
Last Updated
February 25, 2010
Record last verified: 2010-02