Heart failure Circulatory System Heart failure
Conditions
Interventions
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 loca
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 procedure 10. Will be at least 3 months post acute myocardial infarction
Exclusion criteria
Exclusion criteria: 1. Unable to use the technology due to mental or physical limitations 2. Less than 18 years old 3. Pregnancy 4. On a heart transplant list 5. Life expectancy of < one year (non cardiovascular related) in the opinion of the treating physician 6. Current device related complications, e.g. wound infection or haematoma, lead fracture 7. Device implanted less than 6 months previously 8. Patients unable to understand written and spoken English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Contacts
Public ContactSue Kitt
Outcome results
None listed