Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sudden Cardiac Death
- Sponsor
- Zoll Medical Corporation
- Enrollment
- 66
- Primary Endpoint
- Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis
Time Frame: 6 months
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 Outcomes
- Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months(2 months)
- Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months(6 months)
- Compliance With Wearable Cardioverter Defibrillator Therapy(6 months)
- Total Mortality(6 months)
- Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis(6 months)
- Clinical Status of Sudden Cardiac Arrest (SCA) Survivors(48 hours after SCA)
- Incidence of Potentially Life Threatening Arrhythmias(6 months)
- Risk of Inappropriate Therapy(6 months)