ComparIsoN oF Optimal Hypertension RegiMens (INFORM)

Phase 1

Conditions: Cardiovascular Hemodynamics
MedDRA version: 19.0Level: LLTClassification code 10005727Term: Blood pressureSystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-000165-23-GB

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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: subjects 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
a. Currently untreated with EITHER an ABPM daytime average blood pressure of =135 mmHg (systolic) or = 85 mmHg (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)

b. 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/PI, 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).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1320
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if the response to antihypertensive drugs differs by self-defined ethnicity (SDE);Secondary Objective: 1.To determine if the response to antihypertensive drugs differs by <br>a. Ancestry Informative Markers (AIM) <br>b. Baseline metabolomics<br>c. Baseline haemodynamics<br>d. Genomics<br>e. Detailed SDE (family tree (back to grandparents) of ethnicity background/country of birth) comparison with AIM <br><br>2.To determine the most effective mono and dual therapy for hypertension, and whether this varies by ethnicity <br>3.To determine whether metabolomics and haemodynamics differs by ethnicity<br>4.To test whether previously identified biomarkers (derived from other cohorts e.g. US) can predict response to therapy <br><br>;Primary end point(s): • Seated automated office systolic blood pressure. ;Timepoint(s) of evaluation of this end point: • Seated office systolic blood pressure as measured approximately 8 weeks after receiving each treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. To determine if the response to antihypertensive drugs differs by <br>a. AIM <br>b. Baseline metabolomics<br>c. Baseline haemodynamics<br>d. Genomics <br>e. Other potential stratifiers such as age and gender distribution will be monitored<br><br>2. To determine the most effective mono and dual therapy for hypertension, and whether this varies by ethnicity and other potential stratifiers <br>3. To determine whether metabolomics and haemodynamics differs by ethnicity<br>4. To test whether previously identified biomarkers (derived from other cohorts) can predict response to therapy<br>;Timepoint(s) of evaluation of this end point: Planned for all participants<br>• Seated automated office diastolic blood pressure<br>• Core cardiovascular measurements<br>• Detailed Self Defined Ethnicity<br><br>Planned for subgroups <br>• Ambulatory blood pressure and/or Home blood pressure<br>• Optional cardiovascular measurements<br><br>

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