- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519360
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B (RADAR-B)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Restricted ultrafiltration rate (UFR)
UFR ≤10 ml/kg/hr
|
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.
|
EXPERIMENTAL: Standard of Care/ Unrestricted UFR
UFR as needed
|
UFR's will be unlimited and prescribed according to the standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence with Proposed Interventions
Time Frame: 2 years
|
Adherence will be assessed as the percent of sessions in which the mandated UFR is delivered.
|
2 years
|
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.
|
4 months
|
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.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of pre- and post-correction adherence
Time Frame: 2 years
|
This measure will assess adherence to the protocol following any corrective measures made in response to surveys of dialysis staff.
|
2 years
|
Proportion of screened patients enrolled
Time Frame: 2 years
|
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.
|
2 years
|
Association of individual interventions with atrial fibrillation (AF)
Time Frame: 4 months
|
This measure will assess the effect of the interventions on the duration of atrial fibrillation.
|
4 months
|
Association of individual interventions on potentially lethal arrhythmia
Time Frame: 4 months
|
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.
|
4 months
|
The occurrence of clinically significant arrhythmias requiring intervention
Time Frame: 4 months
|
This measure will assess the effect of the interventions on occurrence of arrhythmia requiring clinical intervention.
|
4 months
|
All-cause mortality
Time Frame: 2 years
|
This measure will assess the effect of the interventions on occurrence of all-cause mortality.
|
2 years
|
Cardiovascular mortality
Time Frame: 2 years
|
This measure will assess the effect of the interventions on occurrence of cardiovascular mortality.
|
2 years
|
Hospitalization
Time Frame: 2 years
|
This measure will assess the effect of the interventions on occurrence of hospitalizations.
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of barriers to implementation
Time Frame: 2 years
|
HD staff and patients will be surveyed once 3 subjects have completed 1 month of each trial and once 6 patients have completed each trial to identify barriers to implementation of the protocol.
|
2 years
|
Association of dialysis day, shift, and site with CSA
Time Frame: 2 years
|
Exploratory analyses will assess association of dialysis day (Monday/Wednesday/Friday or Tuesday/Thursday/Saturday), shift (1st-3rd), and site with CSA.
|
2 years
|
Association of dialysis day, shift, and site with adherence
Time Frame: 2 years
|
Exploratory analyses will assess association of dialysis day (Monday/Wednesday/Friday or Tuesday/Thursday/Saturday), shift (1st-3rd), and site with adherence.
|
2 years
|
Association of demographic and pre-randomization factors with adverse events
Time Frame: 2 years
|
Exploratory analyses will assess age, sex, race, mean intra-dialytic weight gain, and mean UFR in month prior to randomization on the incidence of adverse events.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Charytan, MD, MSc, NYU Langone Health
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P001737-
- R34HL140477-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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