Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
NCT ID: NCT02481206
Last Updated: 2021-01-19
Study Results
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View full resultsBasic Information
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TERMINATED
NA
66 participants
INTERVENTIONAL
2015-06-30
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Wearable Cardioverter Defibrillator
End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months
Wearable Cardioverter Defibrillator
Wearable Cardioverter Defibrillator
Conventional Treatment
Conventional Treatment
No interventions assigned to this group
Interventions
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Wearable Cardioverter Defibrillator
Wearable Cardioverter Defibrillator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Zoll Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Wojciech Zareba, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Charles A. Herzog, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota
Locations
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Corona, California, United States
Downey, California, United States
Escondido, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Dimas, California, United States
San Luis Obispo, California, United States
Whittier, California, United States
Stamford, Connecticut, United States
Hialeah, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Winter Garden, Florida, United States
Albany, Georgia, United States
Columbus, Georgia, United States
Fort Wayne, Indiana, United States
Greenbelt, Maryland, United States
Detroit, Michigan, United States
Rochester Hills, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
New Brunswick, New Jersey, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Canton, Ohio, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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90D0126
Identifier Type: -
Identifier Source: org_study_id
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