Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Not Applicable

• Conditions: Cardiovascular Disease
• Interventions: Procedure: dialysis

• Registration Number: NCT00925483
• Lead Sponsor: Dallas VA Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-24
• Last Update Posted: 2010-02-25
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
daily long	dialysis	daily long (4 hours, 6 times weekly) dialysis for 6 months
daily short	dialysis	daily short (2 hours 6 times weekly) dialysis for 6 months
alternate day conventional	dialysis	alternate day conventional (4 hours, 3 times weekly) dialysis for 6 months
alternate day long	dialysis	alternate day long (8 hours, 3 times weekly) dialysis for 6 months

Primary Outcome Measures

Name	Time	Method
LVM change per Cardiac MRI	6 months

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States