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Dialysis Frequency for Cardiovascular Risk

N/A
Waitlist Available
Led By Devasmita C. Dev, MD
Research Sponsored by Dallas VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
End stage renal disease patients on hemodialysis
Be older than 18 years old
Must not have
Weight > 350 lbs
Known poor dialysis and or treatment compliance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is studying whether different types of hemodialysis affect heart function and size in patients with kidney failure.

Who is the study for?
This trial is for people with end-stage renal disease who are on hemodialysis. Participants must be able to attend daily treatments if assigned and tolerate dialysis well, with a life expectancy of more than 6 months. Those over 350 lbs or with poor treatment compliance are not eligible.
What is being tested?
The study compares the effects of different dialysis schedules on heart size and function using cardiac MRI: daily long (4 hours, 6 times weekly), daily short (2 hours, 6 times weekly), alternate day conventional (4 hours, 3 times weekly) or alternate day long (8 hours, 3 times weekly).
What are the potential side effects?
Potential side effects may include discomfort from frequent treatments, fatigue related to longer sessions or increased frequency of dialysis, and any usual risks associated with regular hemodialysis procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on dialysis for end-stage kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I weigh more than 350 lbs.
Select...
I have a history of not following dialysis or treatment plans well.
Select...
I cannot come for daily treatments if assigned to this group.
Select...
I struggle with dialysis and might stop within 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Group I: daily shortExperimental Treatment1 Intervention
daily short (2 hours 6 times weekly) dialysis for 6 months
Group II: daily longExperimental Treatment1 Intervention
daily long (4 hours, 6 times weekly) dialysis for 6 months
Group III: alternate day longExperimental Treatment1 Intervention
alternate day long (8 hours, 3 times weekly) dialysis for 6 months
Group IV: alternate day conventionalExperimental Treatment1 Intervention
alternate day conventional (4 hours, 3 times weekly) dialysis for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dialysis
2020
N/A
~500

Find a Location

Who is running the clinical trial?

Dallas VA Medical CenterLead Sponsor
34 Previous Clinical Trials
4,776 Total Patients Enrolled
Devasmita C. Dev, MDPrincipal InvestigatorVA North Texas Health Care System, Dallas VA Medical Center

Media Library

Dialysis Clinical Trial Eligibility Overview. Trial Name: NCT00925483 — N/A
Cardiovascular Disease Research Study Groups: daily short, alternate day long, alternate day conventional, daily long
Cardiovascular Disease Clinical Trial 2023: Dialysis Highlights & Side Effects. Trial Name: NCT00925483 — N/A
Dialysis 2023 Treatment Timeline for Medical Study. Trial Name: NCT00925483 — N/A
~3 spots leftby Sep 2025
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