Condition category
Circulatory System
Date applied
23/06/2016
Date assigned
27/06/2016
Last edited
27/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic heart failure (CHF) is a long-term condition where the heart has become weakened and isn’t able to pump blood around the body effectively. It is very common, meaning that related hospital admissions and healthcare costs continue to rise. With the ageing population and improving treatment of coronary artery disease (blockage of the main heart arteries), the incidence of heart failure will continue to increase rapidly. Many patients with heart failure now have implantable devices to help manage their condition. The purpose of this study is to help to understand how to better use the information from these devices, in order to prevent death or admission to hospital, and to improve health-related quality of life. Until recently all patients who have a pacemaker (a device which uses electrical pulses to maintain a normal heart rhythm) or defibrillator (a device which shocks the heart into a normal rhythm) fitted have been required to attend routine clinic appointments in hospital to have their device readings checked. Because of advances in technology, some devices now allow physicians to retrieve that information without the need for patients to attend device clinics. Patients with these devices can now transmit their device data from the comfort of their own home. This is done with a small monitor that is used to send device data over a telephone line to a secure server. Clinical staff then access and review the device data remotely. The aim of this study is to see how best hospital study teams can manage patients care using these advances in technology.

Who can participate?
Adults with heart failure who have had an implantable device for at least six months that is suitable for remote monitoring.

What does the study involve?
Patients with devices are randomly allocated to one of two groups. Those in the first group are monitored using remote management technology for heart failure assessment using specific care guidelines. This involves being invited to have their device checked weekly from home over the internet. Those in the second group follow their local hospital routine standard of care which may involve some remote follow up and/or attending hospital device clinics (generally every three to six months). Participants in both groups are contacted by telephone after three, six and twelve months and then yearly until the end of the study (minimum of two years) to ask about their progress. All participants also complete a number of questionnaires to return by post at these times to assess their quality of life.

What are the possible benefits and risks of participating?
There are no known benefits or risks involved with participating in this study.

Where is the study run from?
Southampton General Hospital (lead centre) and eight other NHS hospitals in England (UK)

When is the study starting and how long is it expected to run for?
September 2011 to January 2016

Who is funding the study?
1. British Heart Foundation (UK)
2. Boston Scientific Ltd (UK)
3. Medtronic Ltd (UK)
4. St Jude Medical Ltd (UK)

Who is the main contact?
1. Mrs Sue Kitt (public)
sue.kitt@uhs.nhs.uk
2. Professor Martin Cowie (scientific)
m.cowie@imperial.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Sue Kitt

ORCID ID

http://orcid.org/0000-0001-6051-4810

Contact details

University Hospitals Southampton NHS Foundation Trust
Southampton
SO16 6YD
United Kingdom
+44 23 8120 4633
sue.kitt@uhs.nhs.uk

Type

Scientific

Additional contact

Prof Martin Cowie

ORCID ID

http://orcid.org/0000-0001-7457-2552

Contact details

Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom
+44 207 351 8856
m.cowie@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UKCRN10383

Study information

Scientific title

REmote Monitoring and evaluation of implantable devices for management of Heart Failure patients

Acronym

REM-HF

Study hypothesis

The aim of this study is to assess whether patient-independent remote monitoring using implanted device technology and deployed in clinical pathways designed for chronic management of heart failure in the home will significantly reduce all-cause patient mortality and cardiovascular hospitalisation in the context of NHS care and will be more cost effective than usual care.

Ethics approval

NRES Committee Yorkshire and The Humber- Sheffield, 17/05/2011, ref: 11/YH/0062

Study design

Multicentre randomised non-blinded interventional controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Heart failure

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.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/01/2010

Overall trial end date

31/01/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1650

Participant 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.

Recruitment start date

29/09/2011

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
University Hospital Southampton NHS Foundation Trust Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Royal Brompton Hospital
Royal Brompton and Harefield NHS Foundation Trust Sydney Street
London
SW3 6NP
United Kingdom

Trial participating centre

Blackpool Victoria Hospital
Blackpool Teaching Hospitals NHS Foundation Trust Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

St Thomas' Hospital
Guys and St Thomas' Hospital NHS Foundation Trust Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds Teaching Hospital NHS Trust Great George Street
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Glenfield Hospital
University Hospitals of Leicester NHS Trust Groby Road
Leicester
LE3 9QP
United Kingdom

Trial participating centre

Liverpool Heart and Chest Hospital
Liverpool Heart and Chest Hospital NHS Foundation Trust Thomas Drive
Liverpool
L14 3PE
United Kingdom

Trial participating centre

Wythenshawe Hospital
University Hospital of South Manchester NHS Foundation Trust Southmoor Road Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

Freeman Hospital
Newcastle Hospitals NHS Foundation Trust Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

University Hospital Southampton NHS Foundation Trust

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

Boston Scientific Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medtronic Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

St Jude Medical UK Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Study results will published in peer reviewed scientific journals once the data analysis is complete. The design of the study has been published in the Eur J Heart Failure 2014; 16: 1039-45.
2. Results will additionally be presented at scientific meetings and use our contacts with the British Heart Foundation medical charity to disseminate the results to a wider audience

Intention to publish date

03/09/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/06/2016: Verified study status with principal investigator.