End Stage Renal DiseaseRADAR-BNCT03519360
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B
A study testing UFR-restricted dialysis and UFR-unrestricted dialysis in people with End Stage Renal Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility of trials that change the dialysis ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with kidney failure who are being treated with… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- UFR-restricted dialysis and UFR-unrestricted dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Feb 2021
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Maintenance hemodialysis therapy for end-stage renal disease
- Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
- >30 days since dialysis initiation
- Ability to provide informed consent
- Interdialytic weight gain necessitating an UF rate of ≥13mL/kg/hour of dialysis to achieve the target post-dialysis weight in at least half of the dialysis sessions (≥6 sessions) in the month prior to enrollment
Who cannot join
- Expected survival <6 months-to allow trial completion
- Renal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
- Prisoners or cognitive disability preventing informed consent
- Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months
- Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
- Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
- Existing pacemaker, implantable monitor or defibrillator which precludes device placement
- Chronic, persistent AF (defined as the presence of persistent AF on all available EKGs at time of recent screening)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: RADAR-B: A Phase 2 Multi-center Study to Evaluate the Safety and Tolerability of Using Point-of-Care-Guided Manipulation of Ultrafiltration Rate to Prevent Hemodialysis-Associated Arrhythmias
The purpose of this study is to test the feasibility of trials that change the dialysis ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.
Read the detailed description
Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.
Following ILR implantation, subjects will alternate between weekly periods in which the ultrafiltration rate can be unlimited or in which the ultrafiltration rate is limited to ≤10mL/kg/hour.
- Conditions
- End Stage Renal Disease
- Being tested
- UFR-restricted dialysis, UFR-unrestricted dialysis
- Keywords
- arrythmia, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFR-restricted dialysisOther
UFR's are limited to a maximum of 10 mL/kg/hr for the duration of the session. In order to prevent progressive volume overload and the need for additional hemodialysis sessions to manage volume gains in this scenario, subjects will crossover weekly between the restricted and unrestricted UFR interventions.
UFR-unrestricted dialysisOther
UFR's will be unlimited and prescribed according to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Restricted ultrafiltration rate (UFR) | Experimental | UFR ≤10 ml/kg/hr Receives: Other: UFR-restricted dialysis |
| Standard of Care/ Unrestricted UFR | Experimental | UFR as needed Receives: Other: UFR-unrestricted dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence with Proposed Interventions
Adherence will be assessed as the percent of sessions in which the mandated UFR is delivered.
Measured: 2 years
Incidence of unscheduled hemodialysis or hospitalization for volume overload
The occurrence of unscheduled hemodialysis or ultrafiltration sessions needed to treat volume overload will be measured to assess the impact of the UFR intervention on the adequacy of volume removal.
Measured: 4 months
Change in duration of clinically significant arrhythmia (CSA) per month
The total monthly duration of CSA (in minutes) will be utilized as the primary efficacy endpoint in comparing this pair of interventions (aggressive vs. conservative UF). In the event of incomplete follow-up, CSA duration will be indexed to follow-up time. CSA will be defined on the basis of arrhythmias likely to lead to sudden cardiac arrest (SCA) or serious morbidity and mortality and will include AF, asystole ≥3 seconds, bradycardia ≤40 beats per minute lasting ≥6 seconds, and sustained VT ≥130 beats per minute lasting ≥30 seconds. CSA's will be adjudicated by study electrophysiologists.
Measured: 4 months
Secondary outcomes (8)
Comparison of pre- and post-correction adherence
This measure will assess adherence to the protocol following any corrective measures made in response to surveys of dialysis staff.
Measured: 2 years
Association of individual interventions with atrial fibrillation (AF)
This measure will assess the effect of the interventions on the duration of atrial fibrillation.
Measured: 4 months
Association of individual interventions on potentially lethal arrhythmia
This measure will assess the effect of the interventions on the duration of potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds.
Measured: 4 months
The occurrence of clinically significant arrhythmias requiring intervention
This measure will assess the effect of the interventions on occurrence of arrhythmia requiring clinical intervention.
Measured: 4 months
All-cause mortality
This measure will assess the effect of the interventions on occurrence of all-cause mortality.
Measured: 2 years
Cardiovascular mortality
This measure will assess the effect of the interventions on occurrence of cardiovascular mortality.
Measured: 2 years
Hospitalization
This measure will assess the effect of the interventions on occurrence of hospitalizations.
Measured: 2 years
Proportion of screened patients enrolled
The percent of screened patients enrolled will be calculated as a secondary feasibility measure to assess the size of the necessary screening pool. Reasons for non-enrollment (vis-à-vis inclusion and exclusion criteria and patient and physician preferences) will be assessed to determine the potential for protocol modification to improve recruitment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 Jul 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Logistical difficulties with contracting and with local dialysis unit policies preclueded successful recruiting/enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Duke University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David Charytan, MD, MSc, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519360
- Sponsor's protocol ID
- 2017P001737-
- Other IDs
- R34HL140477-01
- Acronym
- RADAR-B
- Status last verified
- Jul 2021
- First submitted
- 26 Apr 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADAR-B: A Phase 2 Multi-center Study to Evaluate the Safety and Tolerability of Using Point-of-Care-Guided Manipulation of Ultrafiltration Rate to Prevent Hemodialysis-Associated Arrhythmias
- ClinicalTrials.gov ID
- NCT03519360
- Acronym / sponsor ID
- RADAR-B / 2017P001737-
- Conditions
- End Stage Renal Disease
- Keywords
- arrythmia, hemodialysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical difficulties with contracting and with local dialysis unit policies preclueded successful recruiting/enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Duke University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 9 May 2018 (actual)
- 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.
The purpose of this study is to test the feasibility of trials that change the dialysis ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.
Detailed description
Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.
Following ILR implantation, subjects will alternate between weekly periods in which the ultrafiltration rate can be unlimited or in which the ultrafiltration rate is limited to ≤10mL/kg/hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restricted ultrafiltration rate (UFR) | Experimental | Other: UFR-restricted dialysisUFR ≤10 ml/kg/hr |
| Standard of Care/ Unrestricted UFR | Experimental | Other: UFR-unrestricted dialysisUFR as needed |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Maintenance hemodialysis therapy for end-stage renal disease
- Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
- >30 days since dialysis initiation
- Ability to provide informed consent
- Interdialytic weight gain necessitating an UF rate of ≥13mL/kg/hour of dialysis to achieve the target post-dialysis weight in at least half of the dialysis sessions (≥6 sessions) in the month prior to enrollment
Key exclusion criteria (8 listed)
- Expected survival <6 months-to allow trial completion
- Renal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
- Prisoners or cognitive disability preventing informed consent
- Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months
- Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
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 |
|---|---|---|
| UFR-restricted dialysisUFR's are limited to a maximum of 10 mL/kg/hr for the duration of the session. In order to prevent progressive volume overload and the need for additional hemodialysis sessions to manage volume gains in this scenario, subjects will crossover weekly between the restricted and unrestricted UFR interventions. | Other | Restricted ultrafiltration rate (UFR) |
| UFR-unrestricted dialysisUFR's will be unlimited and prescribed according to the standard of care. | Other | Standard of Care/ Unrestricted UFR |
Primary outcome
Adherence with Proposed Interventions
Time frame: 2 years
Adherence will be assessed as the percent of sessions in which the mandated UFR is delivered.
Incidence of unscheduled hemodialysis or hospitalization for volume overload
Time frame: 4 months
The occurrence of unscheduled hemodialysis or ultrafiltration sessions needed to treat volume overload will be measured to assess the impact of the UFR intervention on the adequacy of volume removal.
Change in duration of clinically significant arrhythmia (CSA) per month
Time frame: 4 months
The total monthly duration of CSA (in minutes) will be utilized as the primary efficacy endpoint in comparing this pair of interventions (aggressive vs. conservative UF). In the event of incomplete follow-up, CSA duration will be indexed to follow-up time. CSA will be defined on the basis of arrhythmias likely to lead to sudden cardiac arrest (SCA) or serious morbidity and mortality and will include AF, asystole ≥3 seconds, bradycardia ≤40 beats per minute lasting ≥6 seconds, and sustained VT ≥130 beats per minute lasting ≥30 seconds. CSA's will be adjudicated by study electrophysiologists.
8 secondary outcomes
Comparison of pre- and post-correction adherence
Time frame: 2 years
Association of individual interventions with atrial fibrillation (AF)
Time frame: 4 months
Association of individual interventions on potentially lethal arrhythmia
Time frame: 4 months
The occurrence of clinically significant arrhythmias requiring intervention
Time frame: 4 months
All-cause mortality
Time frame: 2 years
Cardiovascular mortality
Time frame: 2 years
Hospitalization
Time frame: 2 years
Proportion of screened patients enrolled
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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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.
David Charytan, MD, MSc principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UFR-restricted dialysis and UFR-unrestricted dialysis in people with End Stage Renal Disease, run by NYU Langone Health 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 22 Jul 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence with Proposed Interventions (time frame: 2 years). The study lists 3 primary outcomes in all. 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 22 Jul 2021.