Recruiting

Dialysis Types

Sponsor:

Dallas VA Medical Center

Code:

NCT00925483

Conditions

Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

dialysis

Study Details

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.

Conditions

Cardiovascular Disease

Study ID

NCT00925483

Start date

Aug, 2004

Status verified date

Feb, 2010

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: daily long

daily long (4 hours, 6 times weekly) dialysis for 6 months

experimental: daily short

daily short (2 hours 6 times weekly) dialysis for 6 months

experimental: alternate day conventional

alternate day conventional (4 hours, 3 times weekly) dialysis for 6 months

experimental: alternate day long

alternate day long (8 hours, 3 times weekly) dialysis for 6 months

Interventions

dialysis

different dialysis schedules for each arm

Primary outcome measure

  • LVM change per Cardiac MRI [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Dallas VA Medical Center

Recruiting

Dallas, Texas, United States, 75216

Contacts

Devasmita C. Dev, MD

214-857-1593

More Information

Sponsor

Dallas VA Medical Center

Last update posted

Feb 25, 2010

Last verified

Feb, 2010

Keywords

  • left ventricular mass
  • cardiac MRI
  • long dialysis
  • daily dialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dallas VA Medical Center on 2010-02-25.