Sudden Cardiac Arrest, Sudden Cardiac Death
Conditions
Keywords
Ventricular Tachycardia
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.
Interventions
Wearable Cardioverter Defibrillator
Sponsors
Zoll Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis | 6 months | 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. |
| Clinical Status of Sudden Cardiac Arrest (SCA) Survivors | 48 hours after 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). |
| Incidence of Potentially Life Threatening Arrhythmias | 6 months | 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). |
| Total Mortality | 6 months | All cause mortality |
| Compliance With Wearable Cardioverter Defibrillator Therapy | 6 months | 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. |
| Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months | 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. |
| Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months | 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. |
| Risk of Inappropriate Therapy | 6 months | Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| Conventional Treatment Conventional treatment during hemodialysis initiation will be applied to this arm. | 32 |
| Total | 66 |
Baseline characteristics
| Characteristic | Wearable Cardioverter Defibrillator | Conventional Treatment | Total |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 8.6 | 60.1 years STANDARD_DEVIATION 9.5 | 59.7 years STANDARD_DEVIATION 9 |
| Diabetes | 28 Participants | 24 Participants | 52 Participants |
| History of Heart Failure | 9 Participants | 9 Participants | 18 Participants |
| History of Ventricular Arrhythmias | 0 Participants | 1 Participants | 1 Participants |
| Hypertension | 34 Participants | 32 Participants | 66 Participants |
| Previous Myocardial Infarction | 5 Participants | 1 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 5 / 29 | 0 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wearable Cardioverter Defibrillator | Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis | 0 Participants |
| Conventional Treatment | Number of Participants Experiencing Sudden Cardiac Death (SCD) Mortality as Assessed by Intention-to-Treat Analysis | 0 Participants |
Secondary
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).
Time frame: 48 hours after SCA
Population: Study participants from both arms who experienced SCA.
Secondary
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.
Time frame: 6 months
Population: All trial participants who were randomized to wear a wearable cardioverter defibrillator.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wearable Cardioverter Defibrillator | Compliance With Wearable Cardioverter Defibrillator Therapy | .23 Percentage of time available for use | Standard Deviation 0.33 |
Secondary
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wearable Cardioverter Defibrillator | Incidence of Potentially Life Threatening Arrhythmias | 0 VTVF per patient-month |
Secondary
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.
Time frame: 2 months
Population: All subjects completing the KDQOL-36 at 2 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wearable Cardioverter Defibrillator | 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 |
| Conventional Treatment | Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 2 Months | 82.7 units on a scale | Standard Deviation 9.1 |
Secondary
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.
Time frame: 6 months
Population: All subjects completing the KDQOL-36 at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wearable Cardioverter Defibrillator | 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 |
| Conventional Treatment | Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36) As Assessed by As-treated Analysis at 6 Months | 83.4 units on a scale | Standard Deviation 11.7 |
Secondary
Risk of Inappropriate Therapy
Device reported inappropriate shocks/treatments during patient wear time in experimental device wearing arm
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wearable Cardioverter Defibrillator | Risk of Inappropriate Therapy | 0 inappropriate shocks per patient month |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wearable Cardioverter Defibrillator | Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis | 0 patient months |
| Conventional Treatment | Sudden Cardiac Death (SCD) Mortality Assessed by As-treated Analysis | 0 patient months |
Secondary
Total Mortality
All cause mortality
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wearable Cardioverter Defibrillator | Total Mortality | 0 Participants |
| Conventional Treatment | Total Mortality | 0 Participants |