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

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

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.

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