Is it TIME for a change?

Could changing the time of day blood pressure medications are taken improve their effectiveness?

High blood pressure (hypertension) affects one in four adults in the UK, and this can significantly increase your risk of cardiovascular disease including heart attack and stroke. This condition poses a significant threat to the health of millions of people but, once diagnosed, can be managed well with medications.

The Treatment in Morning vs Evening (TIME) study is looking to substantiate the findings of an earlier study (the MAPEC study), which showed a reduction of cardiovascular events in patients that took their hypertensive medication in the evening compared with those who took them in the morning. TIME will look at patients taking once a day blood pressure medication, aiming to establish whether night time dosing is better (or worse) than morning time treatment in preventing heart attacks, strokes, and deaths related to diseases of the heart and circulation. Participants will be randomly allocated to either take anti-hypertensive medication at night or in the morning.

The study is being undertaken by a team based at the University of Dundee led by Professor Tom MacDonald and is backed by a British Heart Foundation research grant. The TIME study is currently recruiting patients across the UK following a successful pilot which has been ongoing since 2011.

Participant Recruitment for the TIME Study

Recruitment to the study is open to anyone in the UK who takes tablets for blood pressure once daily. The aim is to recruit 10,000 participants of as varied demographics as possible and study them over a period of five years. Patients are being invited via GP surgeries and hospitals and by their responding directly to advertising or social media.

Participants need to have regular access to the internet, as this study is done entirely through a secure website and all contact is by email. Although this excludes a certain proportion of patients, for practical and financial reasons it would be difficult to do a study of this size in the conventional way. Previous studies that have used this method found it to yield high quality and cost-effective data.

Patients register for the study at www.timestudy.co.uk, where they can read more detailed information. Consent for the study is completed by the patient online and they then input study data.

Data Security

The TIME study website that has been set up for this study and the data is stored as securely as possible at the University of Dundee. Testing of the system have shown that there are robust security measures in place for the study data. Personal data will be treated with the strictest confidentiality by the staff working on the study.

Involvement of GP Practices

A mailing to all GP practices in the UK has recently been completed asking for practices to indicate if they would be interested in taking part in TIME by writing to all of their hypertensive patients currently on once a day medication. If practices are interested then network support is available to help with patient identification and invitation. Practices can register their interest by emailing the study at time-gpregistrations@dundee.ac.uk, register on the website (www.timestudy.co.uk/GPRegistration.aspx) or return a freepost response slip. Once patients have been invited then no further input is required from practices.

We are also asking if practices can put up posters in their practices even if they do not want to actively invite patients.

Involvement of Hospital Clinics

The study is adopted by the British Hypertension Society and members of their network have already been asked if they can directly invite suitable patients from their clinics. We hope that consultants who are not members of the network will also do the same. Anyone who is interested in finding out more about this can contact the co-ordinating centre in Dundee at TIME-study@dundee.ac.uk.

Summary

If this study showed that the time of day patients take their blood pressure medication can have an effect on events such as strokes and heart attacks, it would provide enormous health benefits. Even getting a modest effect within our study could imply an incredible benefit to the population at large.

We’d like to thank the BHF who have funded this study and the British Hypertension Society who are coordinating it.