Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
13/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof FD Richard Hobbs

ORCID ID

Contact details

Department of Primary Care & General Practice
University of Birmingham
The Medical School
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 8019
f.d.r.hobbs@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/22/11

Study information

Scientific title

Randomised controlled trial and cost effectiveness study of targeted screening versus systematic population screening for atrial fibrillation in the over 65s: the SAFE study

Acronym

SAFE

Study hypothesis

1. To establish the incremental cost effectiveness of different screening options (targeted or population screening) compared with routine clinical practice for detection of AF in over 65s.
2. To determine the value of clinical factors and echocardiography in the process of risk stratification for thromboembolic disease in patients with AF.
3. To determine optimal method of AF diagnosis and ECG interpretation.
4. To assess implications for service provision should screening for AF become a national programme.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Cardiovascular diseases: Heart disease

Intervention

Screening vs control.
24,000 patients aged over 65 will be identified from approximately 24 purposefully selected general practices from the West Midlands. Patient randomisation will result in 5,000 patients invited for screening with 5,000 control patients from the same practice (Principal-control patients). Control practices will provide a further 4,000 control patients (Practice-controls). Prospective identification of pre-existing risk factors for AF within the screened population (estimated at 2,000 patients) will enable comparison between high risk targeted screening and total population screening. Study outcomes will identify the clinical and cost effectiveness of overall screening strategy (2 options compared), actual screening method (4 methods compared), and screening test interpretation (4 options evaluated).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/06/2000

Overall trial end date

31/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients over 65 years

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

15,000

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/06/2000

Recruitment end date

31/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15283871
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17673732
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24728774

Publication citations

  1. Protocol

    Swancutt D, Hobbs R, Fitzmaurice D, Mant J, Murray E, Jowett S, Raftery J, Bryan S, Davies M, Lip G, A randomised controlled trial and cost effectiveness study of systematic screening (targeted and total population screening) versus routine practice for the detection of atrial fibrillation in the over 65s: (SAFE) [ISRCTN19633732]., BMC Cardiovasc Disord, 2004, 4, 12, doi: 10.1186/1471-2261-4-12.

  2. Results

    Fitzmaurice DA, Hobbs FD, Jowett S, Mant J, Murray ET, Holder R, Raftery JP, Bryan S, Davies M, Lip GY, Allan TF, Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial., BMJ, 2007, 335, 7616, 383, doi: 10.1136/bmj.39280.660567.55.

  3. Results

    Fitzmaurice DA, McCahon D, Baker J, Murray ET, Jowett S, Sandhar H, Holder RL, Hobbs FD, Is screening for AF worthwhile? Stroke risk in a screened population from the SAFE study, Fam Pract, 2014, 31, 3, 298-302, doi: 10.1093/fampra/cmu011.

Additional files

Editorial Notes