Work strand 3
AIM HY INFORM – Comparison of optimal hypertension regimens (INFORM)
Lead: Professor Ian Wilkinson – University of Cambridge
In the UK, current NICE guidance (CG127) stratifies hypertension treatment according to age and self-defined ethnicity (SDE). Different initial monotherapies are recommended for all those aged over 55 years, and for younger black compared to white individuals. However, there is no recommended stratification for combination therapy. The evidence base supporting the current guidance on SDE stratification is limited, and there is a specific lack of data from UK-based populations. There is also no reference to South Asians, the largest ethnic minority group in the UK.
Stratification based on ethnicity has a number of recognized limitations. An alternative approach is to stratify based on ancestry informative markers (AIM). This work strand involves a randomized clinical trial and aims to compare the variation in response to antihypertensive drug treatments in three SDE cohorts (South Asians, White Europeans and African/Caribbean) and relate Work from workstrand 1/2 on identifying AIM and metabolomic profiles, to examine whether or not a more effective personalization of antihypertensive treatment can be achieved.
The TRANSFoRm project lead by Prof. Brendan Delaney, provides us with tools like the Query Formulation Workbench (QFW) and the eCRF Data Collection Tool to be used to support the data capture, and facilitate identification of patients for recruitment. The QFW helps researchers to define studies with eligibility criteria sets for participants, build queries to identify eligible participants, flag patients, and extract data for analysis. The eCRF Data Collection Tool, using the CDISC ODM and SDM data standards, will support primary care practitioners and hospitals involved to collect clinical study data and support the collection of patient-reported outcome measures (PROMs) via the web and mobile methods. The pre-population of eCRFs from eHRs can cover between 30% and 50% of the requirements, and integrated electronic data capture for eCRFs and eHRs can have an even higher overlap, depending on the study. This would also reduce the amount of redundant data entry (data recorded in clinical care that can be directly used for clinical research). KCL will be actively involved in the implementation, training and support around the use of these tools at the hospitals and GP practices involved in the trial.
Patient and Public Involvement runs alongside this workstrand with Prof. Christopher McKevitt (KCL) leading it. The AIM HY clinical trial will be supported by the CCTU (Cambridge Clinical Trials Unit) clinical trial coordinators Heike Templin and Elizabeth Kreit. To see the list and contact details to the Trial Sites please click here.
To learn what Professor Ian Wilkinson, the lead of the trial says about the INFORM Clinical Trial, please watch the video below.