Comparison of Optimal Hypertension Regimens

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

High blood pressure (Hypertension) is extremely common and is a major cause of heart disease, kidney disease and stroke. One in three of the UK (United Kingdom) population will require treatment for hypertension at some point in their lives. A healthy lifestyle alone is often not enough to control blood pressure, and drug treatment is usually required. Although a wide variety of drugs are available to treat hypertension, choosing the right kind of tablet or combination of tablets for individual patients is a problem, and therefore many people have poor blood pressure control.

Hypertension treatment within the UK is currently selected according to age and self-defined ethnicity (SDE). There are limitations to this approach which include wide variability in the response to hypertension drug classes between people. There is also uncertainty about selecting hypertension drugs for ethnic minorities other than those of African/Caribbean ancestry, for example, South Asians because of a lack of information from trials. In the AIM HY-INFORM study the investigators are looking to recruit equal number of black/caribbean, south asian and white european participants to be able to compare differences in hypertension treatments and ethnicity.

The primary objective of this study is to determine if the response to antihypertensive drugs differs by self defined ethnicity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborator: Medical Research Council
• Treatments: Amiloride; Amlodipine; Chlorthalidone; Lisinopril

Criteria

Inclusion Criteria:

To be included in the trial the participant must:

1. Have given written informed consent to participate

2. Be aged 18 to 65 years inclusive

3. Self-Define Ethnicity: participants should SELF IDENTIFY into 1 of the three groups below:

White White British White Irish Any other white background

Black or Black British Black Caribbean Black African Any other black background

Asian or Asian British Asian Indian Asian Pakistani Asian Bangladeshi Any other Asian background

4. Be hypertensive defined as:- Mono-therapy rotation

1. currently untreated with EITHER an ABPM day time average blood pressure ≥ 135mmHG (systolic) or ≥ 85mmHg (diastolic) OR Home BP measurements using a validated device based on the average of 10 blood pressure readings of ≥135 mmHg (systolic) or ≥85 mmHg (diastolic)

2. Patients who may be taking antihypertensive drugs at sub therapeutic doses or in ineffective combinations, and who are felt likely to be controllable on a study drug and willing and able to be washed out, at the discretion of the CI (Chief Investigator) / PI (Principal Investigator), can enter the trial if they meet the above criteria.

Dual therapy rotation

a.Treated hypertensive receiving one to three antihypertensive drugs with a blood pressure (ABPM daytime average blood pressure or Home BP as in a.) between 135 or 200 mmHg (systolic) AND between 85 or 110 mmHg (diastolic).

Exclusion Criteria:

The presence of any of the following will mean participants are ineligible:

• Participant does not fit into one of the defined ethnic groups e.g. Mixed

• Pregnant or breastfeeding women

• Known or suspected secondary hypertension

• Significant sensitivity or contraindications to any of the study medications

• Participants taking lithium or are regularly consuming non-steroidal anti-inflammatory drugs at variable doses

• Requirement to take any of the study drugs continuously e.g. ACEi and heart failure

• Any clinically significant hepatic impairment

• Any clinically significant kidney impairment

• Concurrent participation in another clinical trial using systemic vasoactive medications or medications known to interact with the study drugs (participation in another study as part of the AIM HY mechanistic or social science programme will not be an exclusion criterion)

• Patients who are deemed unsuitable by the investigator on clinical grounds