Trial Outcomes & Findings for Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study (NCT NCT02481206)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

6 months

Results posted on

2021-01-19

Participant Flow

Recruitment for the study began on 30-Jun-2015 and ended 15-Feb-2017. Subjects beginning or anticipated to begin dialysis were recruited from kidney clinics and dialysis centers.

Since the sudden death rate is highest early after initiating hemodialysis, subjects could be enrolled from 1 month before starting dialysis to 2 months after. All subjects had to have a left ventricular ejection fraction over 50%. Subjects were shown a wearable defibrillator and were anticipated to be able to use it prior to enrollment.

Participant milestones

Participant milestones
Measure	Wearable Cardioverter Defibrillator End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment End Stage Renal Disease (ESRD) patients beginning hemodialysis will get conventional treatment only.
Overall Study STARTED	34	32
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data entry error on one subject in control group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wearable Cardioverter Defibrillator n=34 Participants End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment n=32 Participants Conventional treatment during hemodialysis initiation will be applied to this arm.	Total n=66 Participants Total of all reporting groups
Age, Continuous	59.3 years STANDARD_DEVIATION 8.6 • n=34 Participants	60.1 years STANDARD_DEVIATION 9.5 • n=32 Participants	59.7 years STANDARD_DEVIATION 9.0 • n=66 Participants
Sex: Female, Male Female	14 Participants n=34 Participants • Data entry error on one subject in control group.	9 Participants n=31 Participants • Data entry error on one subject in control group.	23 Participants n=65 Participants • Data entry error on one subject in control group.
Sex: Female, Male Male	20 Participants n=34 Participants • Data entry error on one subject in control group.	22 Participants n=31 Participants • Data entry error on one subject in control group.	42 Participants n=65 Participants • Data entry error on one subject in control group.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Hypertension	34 Participants n=34 Participants	32 Participants n=32 Participants	66 Participants n=66 Participants
Diabetes	28 Participants n=34 Participants	24 Participants n=32 Participants	52 Participants n=66 Participants
History of Heart Failure	9 Participants n=31 Participants • Missing data on 3 WCD subjects and 1 Control subject	9 Participants n=31 Participants • Missing data on 3 WCD subjects and 1 Control subject	18 Participants n=62 Participants • Missing data on 3 WCD subjects and 1 Control subject
Previous Myocardial Infarction	5 Participants n=32 Participants • Missing data on 2 WCD subjects and 3 Control subjects	1 Participants n=29 Participants • Missing data on 2 WCD subjects and 3 Control subjects	6 Participants n=61 Participants • Missing data on 2 WCD subjects and 3 Control subjects
History of Ventricular Arrhythmias	0 Participants n=34 Participants • Missing data on 2 Control subjects	1 Participants n=30 Participants • Missing data on 2 Control subjects	1 Participants n=64 Participants • Missing data on 2 Control subjects

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Wearable Cardioverter Defibrillator n=29 Participants End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment n=31 Participants Conventional treatment during hemodialysis initiation will be applied to this arm.
Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

All cause mortality

Outcome measures

Outcome measures
Measure	Wearable Cardioverter Defibrillator n=29 Participants End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment n=31 Participants Conventional treatment during hemodialysis initiation will be applied to this arm.
Total Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: To allow for crossovers, the analysis unit is patient months. Note: There were crossover months in the treatment group that were included in the control group for this as-treated analysis. That is, since all WCD users had months during which they did not use a WCD, they are also counted in the WCD not used group.

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.

Outcome measures

Outcome measures
Measure	Wearable Cardioverter Defibrillator n=40 patient months End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment n=320 patient months Conventional treatment during hemodialysis initiation will be applied to this arm.
Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis	0 patient months Interval 0.0 to 0.088	0 patient months Interval 0.0 to 0.012

SECONDARY outcome

Timeframe: 48 hours after SCA

Population: Study participants from both arms who experienced SCA.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: All subjects using a wearable cardioverter defibrillator were included (treatment group assignment and crossovers from control group assignment). Only months with wearable cardioverter defibrillator use were used for calculations.

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).

Outcome measures

Outcome measures
Measure	Wearable Cardioverter Defibrillator n=40 patient-months End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment Conventional treatment during hemodialysis initiation will be applied to this arm.
Incidence of Potentially Life Threatening Arrhythmias	0 VTVF per patient-month Interval 0.0 to 0.098	—

SECONDARY outcome

Timeframe: 6 months

Population: All subjects using a wearable cardioverter defibrillator were included (treatment group assignment and crossovers from control group assignment). Only months with wearable cardioverter defibrillator use were used for calculations.

Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm

Outcome measures

Outcome measures
Measure	Wearable Cardioverter Defibrillator n=40 patient months End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment Conventional treatment during hemodialysis initiation will be applied to this arm.
Risk of Inappropriate Therapy	0 inappropriate shocks per patient month Interval 0.0 to 0.098	—

SECONDARY outcome

Timeframe: 6 months

Population: All trial participants who were randomized to wear a wearable cardioverter defibrillator.

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.

Outcome measures

Outcome measures
Measure	Wearable Cardioverter Defibrillator n=29 Participants End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment Conventional treatment during hemodialysis initiation will be applied to this arm.
Compliance With Wearable Cardioverter Defibrillator Therapy	.23 Percentage of time available for use Standard Deviation .33	—

SECONDARY outcome

Timeframe: 2 months

Population: All subjects completing the KDQOL-36 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.

Outcome measures

Outcome measures
Measure	Wearable Cardioverter Defibrillator n=25 Participants End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment n=28 Participants Conventional treatment during hemodialysis initiation will be applied to this arm.
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months	79.6 units on a scale Standard Deviation 10.6	82.7 units on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: 6 months

Population: All subjects completing the KDQOL-36 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.

Outcome measures

Outcome measures
Measure	Wearable Cardioverter Defibrillator n=16 Participants End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment n=15 Participants Conventional treatment during hemodialysis initiation will be applied to this arm.
Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months	79.9 units on a scale Standard Deviation 12.4	83.4 units on a scale Standard Deviation 11.7

Adverse Events

Wearable Cardioverter Defibrillator

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Conventional Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Wearable Cardioverter Defibrillator n=29 participants at risk End Stage Renal Disease (ESRD) patients beginning hemodialysis will use a Wearable Cardioverter Defibrillator for six months, in addition to conventional treatment.	Conventional Treatment n=31 participants at risk Conventional treatment during hemodialysis initiation will be applied to this arm.
Skin and subcutaneous tissue disorders Discomfort	13.8% 4/29 • 6 months An unanticipated adverse device effect is any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.	0.00% 0/31 • 6 months An unanticipated adverse device effect is any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Social circumstances Frequent false alarms	3.4% 1/29 • 6 months An unanticipated adverse device effect is any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.	0.00% 0/31 • 6 months An unanticipated adverse device effect is any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Additional Information

Director of Clinical Affairs

Zoll

Phone: 724-968-3333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place