Clinical trial NCT02481206: Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Official title: Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sudden Cardiac Death
Sudden Cardiac Arrest
Keywords: Ventricular Tachycardia
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-25
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Patient is unable to consent

Primary outcomes:
measure: Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis
timeFrame: 6 months
Secondary outcomes:
measure: Total Mortality
timeFrame: 6 months
measure: Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis
timeFrame: 6 months
measure: Clinical Status of Sudden Cardiac Arrest (SCA) Survivors
timeFrame: 48 hours after SCA
measure: Incidence of Potentially Life Threatening Arrhythmias
timeFrame: 6 months
measure: Risk of Inappropriate Therapy
timeFrame: 6 months
measure: Compliance With Wearable Cardioverter Defibrillator Therapy
timeFrame: 6 months
measure: Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months
timeFrame: 2 months
measure: Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Corona
country: United States
state: California
city: Downey
country: United States
state: California
city: Escondido
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Dimas
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Whittier
country: United States
state: California
city: Stamford
country: United States
state: Connecticut
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Winter Garden
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Fort Wayne
country: United States
state: Indiana
city: Greenbelt
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Rochester Hills
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: New Brunswick
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Greenville
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: University of Rochester
name: Wojciech Zareba, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota
name: Charles A. Herzog, M.D.
role: PRINCIPAL_INVESTIGATOR
References: