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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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).See study design
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 belowSelect...
I am on dialysis for end-stage kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
LVM change per Cardiac MRI
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
Find a Location
Who is running the clinical trial?
Dallas VA Medical CenterLead Sponsor
34 Previous Clinical Trials
4,775 Total Patients Enrolled
Devasmita C. Dev, MDPrincipal InvestigatorVA North Texas Health Care System, Dallas VA Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis for end-stage kidney disease.I weigh more than 350 lbs.I have a history of not following dialysis or treatment plans well.I cannot come for daily treatments if assigned to this group.I struggle with dialysis and might stop within 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: daily short
- Group 2: alternate day long
- Group 3: alternate day conventional
- Group 4: daily long
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions for participants in this experiment?
"Data found on clinicaltrials.gov reveals that this study is not presently recruiting patients. Even though the trial was first posted in August 2004 and last updated six years ago, there are 424 other active trials searching for participants at present."
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