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NCT00925483 Clinical Trial

Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Cardiovascular Disease Clinical Trial

Official title:
Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00925483
Other study ID # #04-050
Secondary ID
Status Recruiting
Phase N/A
First received June 19, 2009
Last updated February 24, 2010
Start date August 2004

Study information
Verified date February 2010
Source Dallas VA Medical Center
Contact Devasmita C. Dev, MD
Phone 214-857-1593
Email Devasmita.dev@med.va.gov
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• dialysis
different dialysis schedules for each arm

Locations
Country Name City State
United States Dallas VA Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary LVM change per Cardiac MRI 6 months No
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