Condition category
Circulatory System
Date applied
20/05/2019
Date assigned
21/05/2019
Last edited
07/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
AMALFI is a randomized trial of screening for undiagnosed atrial fibrillation (AF - a type of irregular heartbeat) in people thought to be at high risk of having the condition.

Who can participate?
Anyone over 64 years old with a CHA2DS2-VASc score > = 3 in men or > = 4 in women. (CHA2DS2-VASc = Congestive heart failure, Hypertension, Age, Diabetes, Stroke, Vascular disease).

What does the study involve?
The trial aims to randomize 2500 participants in the UK, half of which will wear a CE-marked medical device called the Zio Patch. This is a self-applied ECG monitor that is worn for 2 weeks to assess for signs of AF even if the participant feels well. The intention is to assess the rate of undiagnosed AF to see if earlier detection (and therefore treatment) of undiagnosed AF is worthwhile and results in improved healthcare. If eligible and randomized to wear a patch, they will be sent the device and instructions on how to apply it. After wearing the device for two weeks, it will be returned for analysis and the results sent to their GP who may use the information to decide on the appropriate management. Those not randomized to wear a patch will continue on their usual care.

What are the possible benefits and risks of participating?
Benefits:
Participants who are randomized to receive a Zio Patch will either be reassured that their heart is functioning normally
or they will have a previously undiagnosed AF bought to their GP's attention and therefore their risk of having a stroke
may have been substantially lowered.
If the research is successful, there is a possibility that it may result in a national screening programme that would
benefit everyone.
Risks:
Some participants who are randomized to the group who do not wear the Zio Patch may be disappointed that having volunteered to help, they are not allocated a patch to wear. They may also worry about their chance of having an irregular heart beat that is not detected. Our gratitude for their contribution and the importance of having a control group is made clear in the literature and on the website, so hopefully they will understand the importance of their role. Advice on AF is available in the information provided and if they are still concerned, we recommend that they should see their GP in the usual way.
For those randomized to wear the Zio Patch; there is a chance that the patch may cause a minor irritation to the skin and therefore may cause some unforeseen discomfort to some participants. Individuals with certain skin conditions are recommended not to participate in the study. There is information available in the literature and on the website; we also have a 24-hour Freephone service for anyone who is worried and needs medical or practical advice about the Zio Patch.

If AF is diagnosed from the patch report and an individual's GP decided that treatment is required, the medication can carry some potential risks. However, the care is standard throughout the UK and would have been offered to the participant if AF became apparent to the GP outside of the study. Although earlier diagnosis may mean that the participant receives a longer period on medication, their risk of having a stroke with its associated risks may have been substantially lowered

Where is the study run from?
Clinical Trial Service Unit, Nuffield Department of Public Health, University of Oxford, UK.

When is the study starting and how long is it expected to run for?
The study starts in May 2019 and data collection will continue for up to 25 years.

Who is funding the study?
NIHR Oxford Biomedical Research Centre, UK.

Who is the main contact?
1. Ms Karen Taylor (public),
amalfi@ndph.ox.ac.uk
2. Prof. Louise Bowman (scientific),
amalfi@ndph.ox.ac.uk




Trial website

https://www.amalfitrial.org

Contact information

Type

Scientific

Primary contact

Dr Karen Taylor

ORCID ID

Contact details

Clinical Trial Service Unit
Nuffield Department of Health
University of Oxford
Old Road Campus
Roosevelt Drive
Oxford
OX3 7LF
United Kingdom
01865 743884
amalfi@ndph.ox.ac.uk

Type

Scientific

Additional contact

Prof Louise Bowman

ORCID ID

http://orcid.org/0000-0003-1125-8616

Contact details

Clinical Trial Service Unit
Nuffield Department of Health
University of Oxford
Old Road Campus
Roosevelt Drive
Oxford
OX3 7LF
United Kingdom
01865 743884
amalfi@ndph.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41053

Study information

Scientific title

AMALFI (Active Monitoring for AtriaL Fibrillation): A randomized controlled trial of screening for silent atrial fibrillation in high-risk individuals.

Acronym

AMALFI

Study hypothesis

To assess the effect of 2 weeks of continuous monitoring using Zio Patch on the proportion of participants diagnosed with atrial fibrillation (AF) compared to usual care at 2.5 years of follow up from randomization (i.e. at around the midpoint of a proposed 5-year screening interval).

Ethics approval

Approved 30/01/2019 London - Bromley REC (Metropolitan Police Hayes Sports Club, The Warren, Croydon Road, BR2 7AL; 0207 104 8209; nrescommittee.london-bromley@nhs.net) ref: 19/LO/0220.

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

https://www.amalfitrial.org/about

Condition

Atrial fibrillation

Intervention

Eligible participants will be identified via an electronic search of GP practice data, identifying individuals with risk factors (such as diabetes or high blood pressure) that put them at an increased risk of having a stroke. Men and women aged 65 and over, with a high-risk score, will be approached by mail by their GP and offered the opportunity to participate in the study.

If eligible and randomized to wear a patch, they will be sent the device and instructions on how to apply it. After wearing the device for two weeks, it will be returned for analysis and the results sent to their GP who may use the information to decide on the appropriate management. Those not randomized to wear a patch will continue on their usual care.

If allocated to the study arm that is not required to wear the patch, the participant will receive a letter thanking them for
their contribution. No further input is required from the participant.

Following the initial phase, all participants will continue with their normal care. At 1, 2½ and 5 years after randomization data will be collected from the GP records to assess the proportion of participants diagnosed with AF (as recorded in the electronic GP record) and to see if having AF diagnosed earlier, made a difference to their medical care and stroke rate.

Intervention type

Other

Phase

Drug names

Primary outcome measure

To assess the effect of 2 weeks of continuous monitoring using Zio Patch on the proportion of participants diagnosed with AF compared to usual care at 2.5 years of follow up from randomization (i.e. at around the midpoint of a proposed 5-year screening interval).

Secondary outcome measures

Following the initial phase, all participants will continue with their normal care. At 1, 2½ and 5 years after randomization data will be collected from the GP records to assess the proportion of participants diagnosed with AF (as recorded in the electronic GP record) and to see if having AF diagnosed earlier, made a difference to their medical care and stroke rate.

Overall trial start date

25/03/2019

Overall trial end date

01/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male or Female, aged > = 65 years old.
2. CHA2DS2-VASc score > = 3 in men or > = 4 in women.
3. Willing and able to give informed consent for participation in the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2500; UK Sample Size: 2500

Participant exclusion criteria

1. Known to have AF or atrial flutter
2. Latex allergy (given the potential for an allergic reaction to the Zio Patch)

Recruitment start date

01/05/2019

Recruitment end date

01/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trial Service Unit Nuffield Department of Public Health
University of Oxford Old Road Campus Roosesvelt Drive Headington
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Joint Research Office
1st Floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
01865 572221
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

https://researchsupport.admin.ox.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Oxford Biomedical Research Centre; Grant Codes: n/k

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in Autumn 2023.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/09/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2019: Internal review. 21/05/2019: Uploaded protocol (not peer reviewed) 20/05/2019: Trial’s existence confirmed by NIHR.