Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study (WED-HED)

A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident hemodialysis patients. The study will enroll up to 2,600 subjects. A maximum of 200 sites in the USA will be used for enrollment.

Study Overview

• Status: Terminated
• Conditions: Sudden Cardiac Death; Sudden Cardiac Arrest
• Intervention / Treatment: Device: Wearable Cardioverter Defibrillator

Detailed Description

Objective:

To study the impact of wearable cardioverter defibrillator (WCD) use on sudden cardiac death in hemodialysis patients.

Study Population:

Participants will be patients beginning hemodialysis (<2 months from initiation) who are ≥ 50 years old.

Intervention:

A WCD will be used for protection against sudden cardiac death (SCD).

Study Design:

The study will be a multi-center, prospective, randomized controlled trial with 1:1 assignment of treatment and control.

Study Size:

The study will enroll up to 2,600 subjects. A maximum of 200 sites will be used for enrollment.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Corona, California, United States
    • Downey, California, United States
    • Escondido, California, United States
    • Los Angeles, California, United States
    • Sacramento, California, United States
    • San Dimas, California, United States
    • San Luis Obispo, California, United States
    • Whittier, California, United States
  • Connecticut
    • Stamford, Connecticut, United States
  • Florida
    • Hialeah, Florida, United States
    • Miami, Florida, United States
    • Pembroke Pines, Florida, United States
    • Winter Garden, Florida, United States
  • Georgia
    • Albany, Georgia, United States
    • Columbus, Georgia, United States
  • Indiana
    • Fort Wayne, Indiana, United States
  • Maryland
    • Greenbelt, Maryland, United States
  • Michigan
    • Detroit, Michigan, United States
    • Rochester Hills, Michigan, United States
  • Minnesota
    • Minneapolis, Minnesota, United States
  • Missouri
    • Kansas City, Missouri, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • New Jersey
    • New Brunswick, New Jersey, United States
  • New York
    • Bronx, New York, United States
  • North Carolina
    • Durham, North Carolina, United States
  • Ohio
    • Canton, Ohio, United States
  • South Carolina
    • Greenville, South Carolina, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
    • Knoxville, Tennessee, United States
  • Texas
    • Houston, Texas, United States
    • San Antonio, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• End stage renal disease (ESRD) requiring hemodialysis
• On hemodialysis for ≤ 2 calendar months or scheduled to begin hemodialysis within 1 calendar month
• ≥50 years of age
• Documented Ejection Fraction > 35% within the previous calendar year
• - If the patient has been hospitalized for a myocardial infarction or heart failure decompensation, the Ejection Fraction measurement must have occurred during the last hospitalization or after discharge

Exclusion Criteria:

• Is receiving or will receive hemodialysis due to acute kidney injury and is not expected to receive subsequent chronic hemodialysis therapy
• Patient has an active ICD
• Patient has a unipolar pacemaker
• Patient has physical or mental conditions preventing him/her from interacting with or wearing a Wearable Cardioverter Defibrillator
• Patient has a chest circumference at the level of the xiphoid of < 24 inches
• Patient has a chest circumference at the level of the xiphoid of > 56 inches
• Patient has an advance directive prohibiting resuscitation
• Patient has cancer or other terminal disease (excluding ESRD) with expected survival less than 6 months
• Patient is medically unstable for reasons not specifically related to kidney disease
• Patient is scheduled for live-donor kidney transplantation within 6 calendar months
• Patient is unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wearable Cardioverter Defibrillator; End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months	Device: Wearable Cardioverter Defibrillator; Wearable Cardioverter Defibrillator; Other Names: WCD; LifeVest
No Intervention: Conventional Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis	This is an intention to treat analysis of SCD, with subjects analyzed by randomization assignment regardless of treatment crossovers or noncompliance. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Mortality	All cause mortality	6 months
Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis	This is an as-treated analysis of SCD. For witnessed deaths, SCD will be defined as an unexpected, non-traumatic, non-self-inflicted fatality in otherwise stable subjects who die within one hour of the onset of the terminal symptoms (dialysis noncompliance or withdrawal subjects excluded). Subjects dying more than one hour after a sudden cardiac arrest from a ventricular arrhythmia will be designated as non-sudden death due to ventricular arrhythmia. For unwitnessed deaths, if the subject is found dead within 24 hours of being well the death will be designated as SCD. If more than 24 hours has passed the death will be designated as indeterminate.	6 months
Clinical Status of Sudden Cardiac Arrest (SCA) Survivors	This is an intention to treat analysis of the clinical status of participants who experience an SCA and survive at least 48 hours, as determined by the Glasgow Coma Scale (numeric scale is 3 to 14, higher is better).	48 hours after SCA
Incidence of Potentially Life Threatening Arrhythmias	In the Wearable Cardioverter Defibrillator arm, determine the incidence of potentially life-threatening arrhythmias while the device was worn. Life-threatening arrhythmias are defined as ventricular tachycardia over 150 beats per minute and ventricular fibrillation (VTVF).	6 months
Risk of Inappropriate Therapy	Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm	6 months
Compliance With Wearable Cardioverter Defibrillator Therapy	In the group randomized to receive a Wearable Cardioverter Defibrillator, the device recorded time of use will be used to determine compliance measured as a % of time available for use.	6 months
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months	A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better.	2 months
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months	A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better.	6 months

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Principal Investigator: Wojciech Zareba, M.D., Ph.D, University of Rochester; Principal Investigator: Charles A. Herzog, M.D., Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Ventricular Tachycardia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: 90D0126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No