Clinical trial NCT03519360: Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: arrythmia
hemodialysis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Duke University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adherence with Proposed Interventions
timeFrame: 2 years
measure: Incidence of unscheduled hemodialysis or hospitalization for volume overload
timeFrame: 4 months
measure: Change in duration of clinically significant arrhythmia (CSA) per month
timeFrame: 4 months
Secondary outcomes:
measure: Comparison of pre- and post-correction adherence
timeFrame: 2 years
measure: Association of individual interventions with atrial fibrillation (AF)
timeFrame: 4 months
measure: Association of individual interventions on potentially lethal arrhythmia
timeFrame: 4 months
measure: The occurrence of clinically significant arrhythmias requiring intervention
timeFrame: 4 months
measure: All-cause mortality
timeFrame: 2 years
measure: Cardiovascular mortality
timeFrame: 2 years
measure: Hospitalization
timeFrame: 2 years
measure: Proportion of screened patients enrolled
timeFrame: 2 years
Other outcomes:
measure: Identification of barriers to implementation
timeFrame: 2 years
measure: Association of dialysis day, shift, and site with CSA
timeFrame: 2 years
measure: Association of dialysis day, shift, and site with adherence
timeFrame: 2 years
measure: Association of demographic and pre-randomization factors with adverse events
timeFrame: 2 years
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: NYU Langone Health
name: David Charytan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: