Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Disease |
Procedure: dialysis |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments |
- LVM change per Cardiac MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2004 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: daily long
daily long (4 hours, 6 times weekly) dialysis for 6 months
|
Procedure: dialysis
different dialysis schedules for each arm
|
|
Experimental: daily short
daily short (2 hours 6 times weekly) dialysis for 6 months
|
Procedure: dialysis
different dialysis schedules for each arm
|
|
Experimental: alternate day conventional
alternate day conventional (4 hours, 3 times weekly) dialysis for 6 months
|
Procedure: dialysis
different dialysis schedules for each arm
|
|
Experimental: alternate day long
alternate day long (8 hours, 3 times weekly) dialysis for 6 months
|
Procedure: dialysis
different dialysis schedules for each arm
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Devasmita C. Dev, MD | 214-857-1593 | Devasmita.dev@med.va.gov |
| United States, Texas | |
| Dallas VA Medical Center | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Devasmita C. Dev, MD 214-857-1593 | |
| Principal Investigator: | Devasmita C. Dev, MD | VA North Texas Health Care System, Dallas VA Medical Center |
More Information
No publications provided
| Responsible Party: | Devasmita Dev MD, Dallas VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT00925483 History of Changes |
| Other Study ID Numbers: | #04-050 |
| Study First Received: | June 19, 2009 |
| Last Updated: | February 24, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Dallas VA Medical Center:
|
left ventricular mass cardiac MRI long dialysis daily dialysis |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013