Sudden Cardiac DeathWED-HEDNCT02481206
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
A study testing Wearable Cardioverter Defibrillator in people with Sudden Cardiac Death and Sudden Cardiac Arrest, run by Zoll Medical Corporation at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sudden Cardiac Death, Sudden Cardiac Arrest
- What is being tested?
- Wearable Cardioverter Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 31 sitesUnited States
- Study dates
- Jun 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Study site
Albany, Georgia
Study site
Canton, Ohio
Study site
Chattanooga, Tennessee
Study site
Columbus, Georgia
Study site
Corona, California
Study site
Detroit, Michigan
Study site
Downey, California
Study site
Durham, North Carolina
Study site
Escondido, California
Study site
Fort Wayne, Indiana
Study site
Greenbelt, Maryland
Study site
Greenville, South Carolina
Study site
Hialeah, Florida
Study site
Houston, Texas
Study site
Kansas City, Missouri
Study site
Knoxville, Tennessee
Study site
Las Vegas, Nevada
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
New Brunswick, New Jersey
Study site
Pembroke Pines, Florida
Study site
Rochester Hills, Michigan
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
San Dimas, California
Study site
San Luis Obispo, California
Study site
Stamford, Connecticut
Study site
The Bronx, New York
Study site
Whittier, California
Study site
Winter Garden, Florida
About this 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.
Read the 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.
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest
- Being tested
- Wearable Cardioverter Defibrillator
- Keywords
- Ventricular Tachycardia
- Medical subject headings
- Death, Sudden, Cardiac, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Cardioverter DefibrillatorDevice
Also called WCD, LifeVest
Wearable Cardioverter Defibrillator
| Study group | Role | What they receive |
|---|---|---|
| Wearable Cardioverter Defibrillator | Experimental | End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months Receives: Device: Wearable Cardioverter Defibrillator |
| Conventional Treatment | No intervention | Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis
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.
Measured: 6 months
Secondary outcomes (8)
Total Mortality
All cause mortality
Measured: 6 months
Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis
This is an as-treated analysis of SCD. 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.
Measured: 6 months
Clinical Status of Sudden Cardiac Arrest (SCA) Survivors
This is an intention to treat analysis of the clinical status of participants who experience an SCA and survive at least 48 hours, as determined by the Glasgow Coma Scale (numeric scale is 3 to 14, higher is better).
Measured: 48 hours after SCA
Incidence of Potentially Life Threatening Arrhythmias
In the Wearable Cardioverter Defibrillator arm, determine the incidence of potentially life-threatening arrhythmias while the device was worn. Life-threatening arrhythmias are defined as ventricular tachycardia over 150 beats per minute and ventricular fibrillation (VTVF).
Measured: 6 months
Risk of Inappropriate Therapy
Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm
Measured: 6 months
Compliance With Wearable Cardioverter Defibrillator Therapy
In the group randomized to receive a Wearable Cardioverter Defibrillator, the device recorded time of use will be used to determine compliance measured as a % of time available for use.
Measured: 6 months
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months
A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better.
Measured: 2 months
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months
A self completed questionnaire, the KDQOL-36 has five scales scored from 0 to 100, with higher numbers considered better (i.e., better health related quality of life). For reporting the total score, the 5 scales were averaged for each subject, creating a 0 to 100 range with higher scores considered better.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Lack of subject enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wojciech Zareba, M.D., Ph.D, Principal investigator, University of RochesterCharles A. Herzog, M.D., Principal investigator, Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481206
- Sponsor's protocol ID
- 90D0126
- Acronym
- WED-HED
- Status last verified
- Dec 2020
- First submitted
- 8 Jun 2015
- Last updated
- 19 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
- ClinicalTrials.gov ID
- NCT02481206
- Acronym / sponsor ID
- WED-HED / 90D0126
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest
- Keywords
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of subject enrollment
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 19 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Cardioverter Defibrillator | Experimental | Device: Wearable Cardioverter DefibrillatorEnd Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months |
| Conventional Treatment | No intervention | –Conventional Treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Cardioverter DefibrillatorAlso: WCD, LifeVestWearable Cardioverter Defibrillator | Device | Wearable Cardioverter Defibrillator |
Primary outcome
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.
8 secondary outcomes
Total Mortality
Time frame: 6 months
Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis
Time frame: 6 months
Clinical Status of Sudden Cardiac Arrest (SCA) Survivors
Time frame: 48 hours after SCA
Incidence of Potentially Life Threatening Arrhythmias
Time frame: 6 months
Risk of Inappropriate Therapy
Time frame: 6 months
Compliance With Wearable Cardioverter Defibrillator Therapy
Time frame: 6 months
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months
Time frame: 2 months
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wojciech Zareba, M.D., Ph.D principal investigator
University of Rochester
Charles A. Herzog, M.D. principal investigator
Chronic Disease Research Group, Hennepin County Medical Center, University of Minnesota
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Cardioverter Defibrillator in people with Sudden Cardiac Death and Sudden Cardiac Arrest, run by Zoll Medical Corporation at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.