Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

• Sponsor: Dallas VA Medical Center (U.S. Fed)
• Overall Status: Unknown status
• CT.gov ID: NCT00925483
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Procedure: dialysis	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments
• Study Start Date: Aug 1, 2004
• Anticipated Primary Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. LVM change per Cardiac MRI [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dallas VA Medical Center	Dallas	Texas	United States	75216

Sponsors and Collaborators

• Dallas VA Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00925483
• Other Study ID Numbers: #04-050
• First Posted: Jun 22, 2009
• Last Update Posted: Feb 25, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: left ventricular mass; cardiac MRI; long dialysis; daily dialysis
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Feb 25, 2010