Condition category
Digestive System
Date applied
07/01/2008
Date assigned
27/03/2008
Last edited
27/10/2015
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 Chris Hawkey

ORCID ID

Contact details

Wolfson Digestive Diseases Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 8231033
cj.hawkey@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0700648

Study information

Scientific title

Helicobacter pylori Eradication vs Aspirin Toxicity pilot study

Acronym

HEAT

Study hypothesis

Eradication of H. pylori in patients taking aspirin regularly will reduce the risk of ulcer bleeds.

More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0700648&CaseId=9889

Ethics approval

Nottingham 2 Research Ethics Committee, 21/09/2007

Study design

Part 1: Interventional, non-randomised controlled study. Part 2: Observational database study.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Ulcer bleeding

Intervention

This trial has two parts:

Part 1: Interventional study. This study will establish the H. pylori infection rates and success of eradication therapy.

GPs will screen their patient records for potential participants (Aged >45 and on <300 mg aspirin/day, excluding ulcer healing drugs and NSAIDs) and write to them to invite them to take part in the study. All participants will have a 13C Urea breath test (to establish their H. pylori status) and a blood sample taken (for future H. pylori serology testing). For participants who test negative for H. pylori, this will be the end of their involvement in the study. All patients who test positive for H. pylori (there will be no randomisation) will be given eradication therapy (Clarithromycin 500 mg twice a day [bd], omeprazole 20 mg bd and metronidazole 400 mg bd. Eradication treatment will last 7 days), and retested 6-8 weeks later to test eradication success.

Part 2: Observational study. This is a database study to assess aspirin use in the target population and rates of ulcer bleeds.

Intervention type

Drug

Phase

Not Applicable

Drug names

Clarithromycin, omeprazole, metronidazole

Primary outcome measures

1. Rate of aspirin use (results of Part 2 Observational study)
2. Rate of ulcer bleeding in patients using aspirin (results of Part 2 Observational study)
3. Level of H. pylori infection and subsequent eradication rates in aspirin patients at 6-8 weeks after the eradication therapy
4. Level of interest from GPs and patients for a randomised study and their preferred enrolment site

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/02/2008

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients aged 45 years of age or older
2. Patients who have given written informed consent
3. Patients taking aspirin (less than or equal to 300 mg daily)
NB: Patients who have previously been tested for H. pylori and/or had previous eradication therapy will not be excluded.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

905

Participant exclusion criteria

1. Patients currently taking anti-ulcer therapy (H2-receptor antagonists i.e. cimetidine, famotidine, nizatidine or ranitidine and Proton Pump Inhibitors [PPIs] i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole sodium)
2. Patients currently taking non-selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (aceclofenac, acemetacin, azapropazone, dexibuprofen, dexketoprofen, diclofenac sodium, diflunisal, fenbufen, fenoprofen, flurbiprofen, ibuprofen, indometacin, ketoprofen, mefenamic acid, meloxicam, nabumetone, naproxen, piroxicam, sulindac, tenoxicam, or tiaprofenic acid)
3. Patients who are terminally ill
4. Patients who are allergic to any of the eradication treatment drugs
5. Patients who are currently being treated with an antibacterial or have had antibacterial treatment within the last 4 weeks
6. Patients who have had treatment with a PPI (listed above) within the last 2 weeks.
7. Women who are pregnant or breast feeding

Recruitment start date

01/02/2008

Recruitment end date

31/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Digestive Diseases Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
+44 (0)115 9515679
paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26501118

Publication citations

Additional files

Editorial Notes