Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001451190
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
18/10/2019
Date last updated
18/10/2019
Date data sharing statement initially provided
18/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Intensive Follow-up via Remote Monitoring of Implantable Cardioverter Defibrillators in people with severe left ventricular dysfunction.
Scientific title
The effectiveness of Intensive Follow-up via Remote Monitoring of Implantable Cardioverter Defibrillators in people with severe left ventricular dysfunction.
Secondary ID [1] 299251 0
Nil known
Universal Trial Number (UTN)
Trial acronym
INFORM-ICD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart rhythm disorder 314388 0
Heart Arrythmias 314698 0
Condition category
Condition code
Cardiovascular 312723 312723 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard Remote Monitoring: Each site selected to participate in the study is currently participating in remote monitoring. Sites will continue undertaking remote monitoring. Clinic staff will access RM data via individual device vendor internet-based interfaces. Response to RM data transmissions will be at the discretion of site investigators.

Managed Remote Monitoring: Managed remote monitoring will occur via a cloud-based, automated, vendor-neutral software system with round-the-clock (including overnight, weekend, public holiday) immediate processing of device alerts and scheduled downloads by trained technicians.
Processed device data will be rapidly forwarded to investigational sites. Investigational sites will access processed data, triaged alerts, and updated patient charts via a single, secure internet-based interface including all device vendors. The system will include direct contact made with patients in the event of device transmission failure.

All patients will receive a transmitter to plug in at home next to the bed. Overnight, the transmitter communicates with the ICF and sends messages to the clinic. The participant will not be responsible for sending transmissions as the process is automated. The total duration of the intervention is 24 months.

Those patients randomised to the intensively managed remote monitoring group, or the standard remote monitoring group, will have any data transmitted to the clinic reviewed, and will be contacted in the event of a problem, or in the event that the clinic has not received communication from your ICD for 7 days.

Those patients randomised to clinic follow-up without remote monitoring will have their ICD checked every 6 months during their clinic visit.
Intervention code [1] 315562 0
Treatment: Devices
Comparator / control treatment
Ambulatory Care: Ambulatory care will consist of outpatient in-office clinic visits for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronisation Therapy-Defibrillator (CRT-D) interrogation on a 6-monthly basis, with no ICD interrogation between visits, in the absence of symptoms with an unplanned in-office or emergency department visit. The control group will not have access to home monitoring data until the close of the trial.
Control group
Active

Outcomes
Primary outcome [1] 321383 0
Composite of all-cause mortality, unplanned heart failure/arrhythmia/device-related hospitalisation, and worsened New York Heart Association Functional Classification (NYHA) class.

An independent event adjudication committee will adjudicate clinical events. Mortality events will be evaluated via retrieval of individual patient clinical records.
Unplanned hospital admissions will be assessed by a combination of participant self-reporting, hospital records and treating physician interrogation, and will be defined as an unplanned presentation to an emergency department with overnight stay ie. hours spanning two consecutive days. The date, duration and discharge diagnosis will be recorded. Planned hospitalisations (hospital visits for elective and planned medical interventions) will be excluded.

Non-fatal heart failure events will be as per the MADIT-CRT trial and defined as signs and symptoms of congestive heart failure that was responsive to intravenous diuretics or inotropic support on an outpatient basis or oral/parenteral diuretics during an inpatient stay.

Major adverse cardiac events (MACE) will be assessed by a combination of self-report, hospital record, and clinic record.

NYHA class will be assessed by patient interview.
Timepoint [1] 321383 0
24 months post intervention commencement
Secondary outcome [1] 374833 0
Major adverse cardiac event- assessed via hospital records, participant self-reporting.
Timepoint [1] 374833 0
24 months post intervention commencement
Secondary outcome [2] 375525 0
Inappropriate shocks which will be assessed through device interrogation
Timepoint [2] 375525 0
24 months post consent
Secondary outcome [3] 375526 0
Time in clinical response following an actionable event.
Timepoint [3] 375526 0
Assessed using hospital records, device alerts
Secondary outcome [4] 375527 0
Quality of life as determined by the SF36 Questionnaire the Minnesota Living With Heart Failure questionnaire.
Timepoint [4] 375527 0
24 months post intervention
Secondary outcome [5] 375528 0
Change in New York Heart Association class
Timepoint [5] 375528 0
24 months post intervention
Secondary outcome [6] 375529 0
Unscheduled in office/emergency department visits as determined by hospital/medical records. Clinical data obtained from treating cardiologist.
Timepoint [6] 375529 0
24 months post intervention
Secondary outcome [7] 375530 0
Stroke as determined by hospital/medical records and patient self-reporting.
Timepoint [7] 375530 0
24 months post intervention
Secondary outcome [8] 375531 0
Ventricular arrhythmias requiring device therapy as determined by number of appropriate shocks. This data will be derived from device reports
Timepoint [8] 375531 0
24 months post intervention

Eligibility
Key inclusion criteria
ICD or CRT-D with remote monitoring capabilities
Left ventricular ejection fraction (LVEF) equal to or less than 35%
Willing and able to participate in remote ICD/CRT-D monitoring
Age at least 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Channelopathies
Hypertrophic or restrictive cardiomyopathies
Arrhythmogenic right ventricular dysplasia
ICD/CRT-D lead under advisory
Enrolled in or with intention to participate in a clinical drug and/or device trial which has potential to confound results of this
Life expectancy less than 24 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A database-based patient management system will randomise patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A senior statistician at the Data management and Analysis Centre at the University of Adelaide will be responsible for the statistical analysis. The University of Adelaide will be the institution for the trial. The trial database will be hosted by REDCap (Research Electronic Data Capture database, Vanderbilt University), via the South Australian Health and Medical Research Institute and the University of Adelaide. The REDCap web-based data management system will be established to allow multiple researchers to enter the collected trial data simultaneously, to assist in patient tracking and generation of patient follow-up schedules.
The primary endpoint of the trial is a combination of all-cause mortality, hospitalisation for heart failure/arrhythmia/device-related events, and worsening of symptoms (as defined by the New York Heart Association class system). The event rate in the control arm is estimated at 16.8% over 12 months. We postulate that this would increase to 24.6% after 2-years (i.e. 1.5 x annual event rate). The trial is powered to find a 10% relative reduction in event rate between the control arm and the intervention arms (with potential for even greater relative reduction in the intensively managed intervention arm), with sample sizes calculated with default values for a=0.05 and 1-ß=0.80. A 10% dropout (study withdrawal) rate has been accounted for. Using these assumptions, it is estimated that n=280 patients will be required for each treatment arm, for a total n=840 recruitment.
Analyses will be conducted under the intention to treat principle. We will use logistic regression to calculate hazard ratios for the composite of all-cause mortality and unplanned hospitalisations. Time to event data will be analysed using the Kaplan-Meier method with comparison between-groups using Log-Rank statistics with two degrees of freedom. Pre-specified subgroups analysis will be performed using Cox-proportional hazards regression. The subgroups will be: female patients, male patients, patients with at least NYHA class II symptoms at enrolment, CRT-D patients, and all participants divided according to their device brand.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 303786 0
Commercial sector/Industry
Name [1] 303786 0
PACEMATE- Provision of database and managed home monitoring services
Country [1] 303786 0
United States of America
Primary sponsor type
University
Name
Centre for Heart Rhythm Disorders, University of Adelaide
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 303935 0
None
Name [1] 303935 0
Address [1] 303935 0
Country [1] 303935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304307 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
Ethics committee address [1] 304307 0
Ethics committee country [1] 304307 0
Australia
Date submitted for ethics approval [1] 304307 0
Approval date [1] 304307 0
18/07/2019
Ethics approval number [1] 304307 0
AU/1/64E837

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96474 0
Prof Prashanthan Sanders
Address 96474 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Port Road, SA 5000
Country 96474 0
Australia
Phone 96474 0
+61 08 8313 9000
Fax 96474 0
+61 8 8313 2273
Email 96474 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 96475 0
Rebecca Leinonen
Address 96475 0
Cardiovascular Investigation Unit
Royal Adelaide Hospital
Port Road, SA Adelaide 5000
Country 96475 0
Australia
Phone 96475 0
+61 8 8128 4595
Fax 96475 0
Email 96475 0
rebecca.leinonen@adelaide.edu.au
Contact person for scientific queries
Name 96476 0
Prashanthan Sanders
Address 96476 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Port Road, SA 5000
Country 96476 0
Australia
Phone 96476 0
+61 08 8313 9000
Fax 96476 0
+61 8 8313 2273
Email 96476 0
prash.sanders@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be published as a full set with no individual data made available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.