HEAT (Helicobacter Eradication Aspirin Trial) is a large simple double-blind placebo
controlled outcomes study of Helicobacter pylori (H. pylori) eradication to prevent ulcer
bleeding in aspirin users. It will be run by the University of Nottingham, with recruiting
centres across the UK. This trial is funded by the National Institute of Health Research
Health Technology Assessment (NIHR HTA) Programme.
Aspirin use is widespread and increasing in elderly patients. The main hazard is
gastrointestinal bleeding, which may be increasing because of increasing aspirin use. This
trial is based on evidence that peptic ulcer bleeding in aspirin users occurs predominantly
in H. pylori positive people.
Patients will be identified by their GPs, then asked to attend an appointment with a Research
Nurse to consent to the trial and take a H. pylori breath test. Those with a positive result
will be randomised to receive a one week course of either eradication treatment or placebo.
No follow-up visits are required, but instead information will be extracted from the
patients' electronic medical record using the MiQuest search tool.
The trial will continue until 87 adjudicated events (hospitalisation because of definite or
probable peptic ulcer bleeding) have occurred, which would occur after a mean 2.5 patient
years of follow-up, if trial assumptions are correct.
Phase:
Phase 4
Details
Lead Sponsor:
University of Nottingham
Collaborators:
Nottingham University Hospitals NHS Trust Queen's University, Belfast University of Birmingham University of Durham University of Oxford University of Southampton