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HEAT (Helicobacter Eradication Aspirin Trial): Can eradication prevent ulcer bleeding?

HEAT: Helicobacter Eradication Aspirin Trial

HEAT (Helicobacter Eradication Aspirin Trial) is a large scale outcomes study designed to see whether a one week course of H. pylori eradication reduces hospitalisation for ulcer bleeding in patients using aspirin.

With funding from the National Institute of Health Research Health Technology Assessment Programme, it is being led by the University of Nottingham, with recruiting centres across the UK.

Background

About 28% of people aged over 60 in England take aspirin 75-300mg for its anti-platelet properties. In 2007 there were 12,864 hospital admissions in England for gastric duodenal or peptic ulcer haemorrhage (over three quarters were in people aged 60+).

The trial will recruit from 13 Comprehensive Local Research Networks and 67 PCTs, which makes up 49.4% of the population.

Ten years ago aspirin was identified as the single commonest cause of gastric ulcer haemorrhage. Since then UK aspirin use has risen by 75% and there has been a rise in ulcer bleeding attributed to this increased aspirin use.

The risk of upper GI bleeding in patients taking aspirin is three times higher than in patients not taking aspirin. An endoscopy study of patients taking aspirin found ulcers were increased 5-fold in H. pylori positive versus H. pylori negative subjects. This study will investigate whether low-dose aspirin acts via a haemostatic effect to provoke bleeding in ulcers caused by H. pylori, rather than having an ulcerogenic role itself.

Trial objectives

The research has three primary objectives:

  • Medical: To test the hypothesis that a one week course of H. pylori eradication in patients using aspirin ≤325mg daily will reduce the incidence of subsequent peptic ulcer bleeding that results in hospitalisation.
  • Economic: To test the hypothesis that the intervention has a positive net monetary benefit (the cost of hospitalisation due to an ulcer bleed is very expensive to the NHS – in the region of £15,000 per event).
  • Methodological: To establish a methodology for large simple outcomes studies using electronically extracted Primary Care follow-up data, to reduce costs to a level that enables outcomes studies of clinically important questions to be done without the need for industry support.

Inclusion and exclusion criteria

Inclusion

  • ≥ 60 years of age
  • Subjects taking aspirin ≤325mg daily who have had 4 or more 28-day prescriptions in the last year.
  • Subjects concurrently using other anti-platelet agents are allowed to enter the study.

Exclusion

  • Subjects currently taking anti-ulcer therapy such as H2-receptor antagonists and proton-pump inhibitors.
  • Subjects currently taking non-steroidal anti-inflammatory drugs (NSAIDs).

Patient Recruitment

‘Helicobacter Test INFAI’ is a breath test kit, widely used in the NHS to determine the presence of H. pylori in the stomach. The test will be conducted by suitably trained research nurses during the patient’s screening visit.

Patients will be recruited in a primary care setting via their GP. People aged 60 and over, who require chronic aspirin therapy (≤325mg daily) will be identified using an automated search of computer databases in participating GP practices. Patients deemed suitable by their GP and who agree to take part will be seen by HEAT research nurses at their local GP surgery. The nurses will provide information about the trial, obtain informed consent from the patient, and perform a brief health check and a breath test for H. pylori.

Patients will be informed of the result of their breath tests by post. Those testing positive will be randomised to receive either eradication treatment or placebo, which will be sent by post.

Patient Follow-up

Patients will be followed up for 2-3 years. There will be no face-to-face follow-up visits but patients will be asked to inform the HEAT team if they go into hospital. GP records will be searched annually to identify any hospital admission possibly due to an ulcer bleed, as well as current health and prescribing information.

Pilot Study

The pilot study showed a higher than anticipated patient response rate. H. Pylori +ve 23.5% (13.3 – 44.0%) of those tested. Unsupervised treatment showed very high eradication rates of >90% (assessed ≥6 weeks later).

In our MRC-funded pilot study we wrote to 2525 patients, with 47% replying, and 33% of those invited suitable. Of the suitable patients, 24% were H. pylori positive with successful eradication in 91%.

Large scale design

For the HEAT trial we expect to write to 120,000 patients and anticipate about 40,000 responses. Of these we predict there will be 10,000 patients positive for H. pylori who will be randomised to the trial.

Benefit for GPs: Why should I take part?

  • Simple study – low workload, ideal for practices new to research.
  • Large experienced team on hand to help with any queries.
  • Opportunity for developing research in your practice (GCP training available)
  • If all participating patients ultimately undergo eradication, the trial should prevent around 585 hospitalisations and 59 deaths, at a saving of approximately £5.85 million.
  • Easy to do – 1 week of treatment, no follow-up.
  • Participating practices will be reimbursed applicable service support costs.

Interested?

If you would like more information about the HEAT study please contact us.
We will be happy to give a short presentation at your practice and answer any questions you may have.

The HEAT team, based at Nottingham University. Far right: Professor Chris Hawkey, Chief Investigator.

HEAT Central Trial Office
Nottingham Digestive Diseases Centre (NDDC)
E Floor, W Block
University Hospital
Nottingham NG7 2UH

Chief Investigator: Professor Chris Hawkey
Trial Manager: Jennifer Dumbleton
0115 823 1053
jennifer.dumbleton@nottingham.ac.uk

Regional Principal Investigators:
Professor Greg Rubin (Durham)
Dr Mike Moore (Southampton)
Professor Richard Hobbs (Oxford/Birmingham)

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