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

Zoll Medical Corporation66 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sudden Cardiac Death Sudden Cardiac Arrest

Interventions

Wearable Cardioverter DefibrillatorDEVICE

Wearable Cardioverter Defibrillator

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (31)

Unnamed facility

Corona, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

Total Mortality

All cause mortality

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

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