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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sudden Cardiac Death, Sudden Cardiac Arrest

Intervention / Treatment
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* Device: Wearable Cardioverter Defibrillator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable Cardioverter Defibrillator<br>End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months | Device: Wearable Cardioverter Defibrillator<br>* Wearable Cardioverter Defibrillator<br>* Other names: LifeVest;|
| No Intervention: Conventional Treatment<br>Conventional Treatment | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Tachycardia