Cardiovascular DiseaseNCT00925483
Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments
A study testing dialysis in people with Cardiovascular Disease, run by Dallas VA Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- dialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage renal disease patients on hemodialysis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dallas VA Medical Center
Dallas, Texas, 75216
Devasmita C. Dev, MD, 214-857-1593
About this study
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.
- Conditions
- Cardiovascular Disease
- Being tested
- dialysis
- Keywords
- left ventricular mass, cardiac MRI, long dialysis, daily dialysis
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysisProcedure or surgery
different dialysis schedules for each arm
| Study group | Role | What they receive |
|---|---|---|
| daily long | Experimental | daily long (4 hours, 6 times weekly) dialysis for 6 months Receives: Procedure: dialysis |
| daily short | Experimental | daily short (2 hours 6 times weekly) dialysis for 6 months Receives: Procedure: dialysis |
| alternate day conventional | Experimental | alternate day conventional (4 hours, 3 times weekly) dialysis for 6 months Receives: Procedure: dialysis |
| alternate day long | Experimental | alternate day long (8 hours, 3 times weekly) dialysis for 6 months Receives: Procedure: dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVM change per Cardiac MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startAug 2004
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- Devasmita C. Dev, MD, Principal investigator, VA North Texas Health Care System, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925483
- Sponsor's protocol ID
- #04-050
- Status last verified
- Feb 2010
- First submitted
- 19 Jun 2009
- Last updated
- 25 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments
- ClinicalTrials.gov ID
- NCT00925483
- Acronym / sponsor ID
- #04-050
- Conditions
- Cardiovascular Disease
- Keywords
- left ventricular mass, cardiac MRI, long dialysis, daily dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- Aug 2004
- Primary completion
- Dec 2012 (estimated)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| daily long | Experimental | Procedure: dialysisdaily long (4 hours, 6 times weekly) dialysis for 6 months |
| daily short | Experimental | Procedure: dialysisdaily short (2 hours 6 times weekly) dialysis for 6 months |
| alternate day conventional | Experimental | Procedure: dialysisalternate day conventional (4 hours, 3 times weekly) dialysis for 6 months |
| alternate day long | Experimental | Procedure: dialysisalternate day long (8 hours, 3 times weekly) dialysis for 6 months |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End stage renal disease patients on hemodialysis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dialysisdifferent dialysis schedules for each arm | Procedure or surgery | alternate day conventional, alternate day long, daily long, daily short |
Primary outcome
LVM change per Cardiac MRI
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devasmita C. Dev, MD principal investigator
VA North Texas Health Care System, Dallas VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dialysis in people with Cardiovascular Disease, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Devasmita C. Dev, MD (214-857-1593, Devasmita.dev@med.va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVM change per Cardiac MRI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2010.