Completed Heart, Stroke & Blood Diabetes, Hormones & Metabolism

Treatment In the Morning versus Evening (TIME study)

In plain English

AI plain-English summary

A large-scale trial is asking 10,269 people with high blood pressure to switch their medication from morning to evening to see if it prevents more heart attacks and strokes. The problem is that timing matters for blood pressure drugs, but no one knows for certain whether taking them at night reduces cardiovascular events better than the standard morning dose. Previous smaller studies have suggested a benefit, but the evidence is not definitive enough to change clinical guidelines. This trial aims to settle the question with a four-year follow-up, tracking hospitalisations and deaths through linked health records. If evening dosing proves superior, the change would be trivial for patients—swallowing a pill at a different time of day—but could meaningfully reduce the burden of heart disease and stroke across the UK population. The trial’s automated, web-based recruitment and follow-up system also demonstrates a low-cost model for running large pragmatic trials without requiring frequent clinic visits. If the result is negative, it will spare millions of people from an unnecessary change to their daily routine. Either way, the answer will be definitive.

View original technical description
An outcome event trial of treated hypertensive subjects of all ages comparing evening dosing of usual antihypertensive therapy with conventional morning dosing is proposed. 10,269 subjects already taking antihypertensive medication in usual care will be recruited from general practices, secondary care clinics or by social media and followed up for 4 years. Subjects participate by registering on a study-specific website. Subjects who meet the inclusion criteria are randomised to continue taking medication at their usual time (usually morning) or to switch to taking medication in the evening. Subjects receive regular emails with simple links to record responses to track progress. This largely automated system has worked well in the pilot phase with good patient retention. Record-linkage to hospitalisations and deaths will be carried out and events adjudicated. The primary outcome is the composite endpoint of non-fatal myocardial infarction, non-fatal stroke or vascular death. A pilot study has randomised 388 patients with > 1 year follow-up, has confirmed the feasibility of this approach.

View the original record at the funder ↗

Researchers

Thomas MacDonald (EPMC Awardee)

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Original classification

Clinical Study

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