Remote monitoring in heart failure patients

INTERVENTION: Participants are randomised to one of two groups. Group 1: Participants will be set up with remote device monitoring and arrangements made for a weekly device download to be transmitted to their local study hospital. Some participants may already use remote monitoring but this will be on a much less frequent basis, usually 3 to 6 monthly. The weekly downloads will be reviewed by the nurse or cardiac technician who are the “trained study remote monitor”. The monitor will review the weekly downloads and take any appropriate actions which are then documented as part of the study data. Group 2: Participants will have their device care managed according to the usual care in their local hospital. Both groups will be contacted by telephone at 3, 6, 12 month and yearly following enrolment to ask about their progress. Data regarding their progress will be collected from the telephone follow up and supported by hospital and GP medical records. All participants will be required to complete “Quality of Life” (QOL) questionnaires at baseline, 3, 6, 12 and 24 months following enrolment. The latter 4 QOL questionnaires may be sent in the post. Depending on the date of their enrolment each participant will be followed up in the study for up to 4 years with a minimum of 2 years follow up. CONDITION: Heart failure ; Circulatory System ; Heart failure PRIMARY OUTCOME: Combined all‐cause mortality (ACM) or unplanned cardiovascular (CV) hospitalisation (whichever comes first) rate is determined through follow up interviews at 3, 6, 12 month, 2 years and for the early recruiters up to 4 years. Data will be collected from a combination of participant interviews, reviewing hospital and GP records and by obtaining copies of death certificates where available from the Health and Social Care Information Centre. INCLUSION CRITERIA: 1.Participants will all have received an Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronisation Therapy‐Pacemaker (CRT‐P) or Cardiac Resynchronisation Therapy‐Defibrillator (CRT‐D) at least six months previously, for the treatment and monitoring of chronic heart failure 2.Be on stable medical therapy for CHF for 6 weeks prior to recruitment 3.Will have the ability to independently comprehend and complete Quality of Life Questionnaires 4. Will have the ability to give informed consent 5. Will be on optimal medical therapy according to the treating physician, working to NICE Guidelines 6. Will have had their device programmed to give optimal therapy according to the treating physician 7. Will have symptomatic heart failure (i.e. NYHA Class II to IV) documented at the time of study enrolment 8. Will be at least 30 days post any device change or lead replacement procedure 9. Will be at least 3 months post any cardiac surgical pro SECONDARY OUTCOME: Unless otherwise stated, secondary outcome measures will be measured at the last follow‐up or at the last available observation within the two year follow‐up period.; ; 1. Time to death is measured by time from randomisation to date of death; 2. Time to a cardiovascular related death is measured by time from randomisation to date of death; 3. Time to a non‐cardiovascular related death is measured by time from randomisation to date of death; 4. Time to first unplanned hospitalisation for cardiovascular reasons or cardiovascular related death is measured by time from randomisation to date of event; 5. Time to first unplanned hospitalisation for non‐cardiovascular reasons or death by any cause is measured by time from randomisation to date of event; 6. Time to first unplanned hospitalisation for cardiovascular reasons is measured by time from randomisation to date of event; 7. Time to first unplanned hospitalisation for non‐cardiovascular reasons is measured by time from randomisation to date of event; 8. Total number of unplanned hospitalisations is measured by the total number of these episodes during the follow up period; 9. Total number of unplanned hospitalisations for cardiovascular reasons is measured by the total number of these episodes during the follow‐up period; 10. Health related quality of life is measured using the SF12 (physical and mental health components) at baseline,3 month, 6 month, 12 month, 1 and 2 years; 11.Health related quality of life is measured using the EQ5D at baseline, 3 month, 6 month, 12 month, 1 and 2 years; 12.Health related quality of life is measured using the KCCQ at baseline, 3 month, 6 month, 12 month, 1 and 2 years; 13. Number and cost of hospitalisations is measured by applying the national tariff costs to the hospitalisation episodes; 14. Difference in cost of resources consumed is measured by applying appropriate costs to both arms of the studies and comparing these for the duration of the study; 15. Difference in cost of cardiovascular related health care use is measured by applying the appropriate costs to both arms of the studies and comparing these for the duration of the study; 16. Incremental costs per quality‐adjusted life years (QALYs) is measured by dividing the difference in costs between both arms of the study by the difference in QALYs between the arms