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

Primary Purpose

Sudden Cardiac Death, Sudden Cardiac Arrest

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable Cardioverter Defibrillator
Sponsored by
Zoll Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sudden Cardiac Death focused on measuring Ventricular Tachycardia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wearable Cardioverter Defibrillator

Conventional Treatment

Arm Description

End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months

Conventional Treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total Mortality
All cause mortality
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.
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).
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).
Risk of Inappropriate Therapy
Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm
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.
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.
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.

Full Information

First Posted
June 8, 2015
Last Updated
December 23, 2020
Sponsor
Zoll Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02481206
Brief Title
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Acronym
WED-HED
Official Title
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of subject enrollment
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zoll Medical Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Cardiac Death, Sudden Cardiac Arrest
Keywords
Ventricular Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearable Cardioverter Defibrillator
Arm Type
Experimental
Arm Description
End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months
Arm Title
Conventional Treatment
Arm Type
No Intervention
Arm Description
Conventional Treatment
Intervention Type
Device
Intervention Name(s)
Wearable Cardioverter Defibrillator
Other Intervention Name(s)
WCD, LifeVest
Intervention Description
Wearable Cardioverter Defibrillator
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total Mortality
Description
All cause mortality
Time Frame
6 months
Title
Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis
Description
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.
Time Frame
6 months
Title
Clinical Status of Sudden Cardiac Arrest (SCA) Survivors
Description
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).
Time Frame
48 hours after SCA
Title
Incidence of Potentially Life Threatening Arrhythmias
Description
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).
Time Frame
6 months
Title
Risk of Inappropriate Therapy
Description
Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm
Time Frame
6 months
Title
Compliance With Wearable Cardioverter Defibrillator Therapy
Description
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.
Time Frame
6 months
Title
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months
Description
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.
Time Frame
2 months
Title
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wojciech Zareba, M.D., Ph.D
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles A. Herzog, M.D.
Organizational Affiliation
Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
City
Corona
State/Province
California
Country
United States
City
Downey
State/Province
California
Country
United States
City
Escondido
State/Province
California
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United States
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Los Angeles
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United States
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Sacramento
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San Dimas
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San Luis Obispo
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Whittier
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Stamford
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Hialeah
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Miami
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Pembroke Pines
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Winter Garden
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Albany
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Georgia
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Columbus
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Fort Wayne
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Indiana
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Greenbelt
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Maryland
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Detroit
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Michigan
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Rochester Hills
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Minneapolis
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Minnesota
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Kansas City
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Missouri
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Las Vegas
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Nevada
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New Brunswick
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New Jersey
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Bronx
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New York
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Durham
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North Carolina
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Canton
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Ohio
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Greenville
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South Carolina
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Chattanooga
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Tennessee
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United States
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Knoxville
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Tennessee
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United States
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Houston
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Texas
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United States
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San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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