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Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Dallas VA Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT00925483
First received: June 19, 2009
Last updated: February 24, 2010
Last verified: February 2010
  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

Resource links provided by NLM:


Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925483

Contacts
Contact: Devasmita C. Dev, MD 214-857-1593 Devasmita.dev@med.va.gov

Locations
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Devasmita C. Dev, MD    214-857-1593      
Sponsors and Collaborators
Dallas VA Medical Center
Investigators
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 November 25, 2014