Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

February 24, 2010 updated by: Dallas VA Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Recruiting
        • Dallas VA Medical Center
        • Contact:
          • Devasmita C. Dev, MD
          • Phone Number: 214-857-1593

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LVM change per Cardiac MRI
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dallas VA Medical Center

Investigators

  • Principal Investigator: Devasmita C. Dev, MD, VA North Texas Health Care System, Dallas VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 24, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #04-050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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