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Trial record 1 of 1 for:    NCT03519360
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Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B (RADAR-B)

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ClinicalTrials.gov Identifier: NCT03519360
Recruitment Status : Not yet recruiting
First Posted : May 9, 2018
Last Update Posted : May 24, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Charytan, NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Other: UFR-restricted dialysis Other: UFR-unrestricted dialysis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Restricted ultrafiltration rate (UFR)
UFR ≤10 ml/kg/hr
Other: UFR-restricted dialysis
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
Other: UFR-unrestricted dialysis
UFR's will be unlimited and prescribed according to the standard of care.




Primary Outcome Measures :
  1. 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. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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. 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.

  5. All-cause mortality [ Time Frame: 2 years ]
    This measure will assess the effect of the interventions on occurrence of all-cause mortality.

  6. Cardiovascular mortality [ Time Frame: 2 years ]
    This measure will assess the effect of the interventions on occurrence of cardiovascular mortality.

  7. Hospitalization [ Time Frame: 2 years ]
    This measure will assess the effect of the interventions on occurrence of hospitalizations.

  8. 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.


Other Outcome Measures:
  1. 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. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519360


Contacts
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Contact: David M Charytan, MD, MSc 646-501-9086 david.charytan@nyulangone.org

Locations
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United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Patrick Pun, MD    919-672-2464    patrick.pun@duke.edu   
Sponsors and Collaborators
NYU Langone Health
National Institutes of Health (NIH)
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: David Charytan, MD, MSc NYU Langone Health

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Responsible Party: David Charytan, Chief, Division of Nephrology, NYU Langone Health
ClinicalTrials.gov Identifier: NCT03519360     History of Changes
Other Study ID Numbers: 2017P001737-
R34HL140477-01 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by David Charytan, NYU Langone Health:
arrythmia
hemodialysis

Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases