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

Stopped early · Not applicable

Conditions studied: Sudden Cardiac Death, Sudden Cardiac Arrest

In brief

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.

Key facts

Study ID

NCT02481206

Run by

Zoll Medical Corporation

People needed

66

Starts

2015-06-01

Expected to finish

2017-12-01

Last updated by the study team

2021-01-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Corona, California, United States
• Study site — Downey, California, United States
• Study site — Escondido, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — San Dimas, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — Whittier, California, United States
• Study site — Stamford, Connecticut, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Winter Garden, Florida, United States
• Study site — Albany, Georgia, United States
• Study site — Columbus, Georgia, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Greenbelt, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Rochester Hills, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — The Bronx, New York, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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