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Comparison of Optimal Hypertension Regimens (AIMHY-INFORM)

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ClinicalTrials.gov Identifier: NCT02847338
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Dr Ian B Wilkinson, Cambridge University Hospitals NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine Drug: Lisinopril Drug: Amiloride Drug: Chlortalidone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1320 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Optimal Hypertension Regimens (Part of the Ancestry Informative Markers in Hypertension (AIMHY) Programme - AIMHY-INFORM)
Study Start Date : November 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mono-therapy group

The monotherapy group will be treated with the following treatments:

A) 1 to 2 weeks of Amlodipine 5mg followed by 6 to 7 weeks of Amlodipine 10mg B) 1 to 2 weeks of Lisinopril 10mg followed by 6 to 7 weeks of Lisinopril 20mg C) Approximately 8 weeks of 25mg Chlortalidone

Participants will be randomly allocated to one of six possible sequences of treatments of the three-treatment-three period Williams design: ABC, ACB, BAC, BCA, CAB, and CBA.

Drug: Amlodipine
Amlodipine 5mg and Amlodipine 10mg will be one of the treatments in which patients will receive on the monotherapy arm and on the dual therapy arm.

Drug: Lisinopril

Lisinopril 10mg and Lisinopril 20mg will be one of the treatments in which patients will receive on the monotherapy arm.

Lisinopril 20mg will be one of the treatments in which patients will receive on the dual therapy arm.


Drug: Chlortalidone
Chlortalidone 25mg will be one of the treatments in which patients will receive on the dual therapy arm and monotherapy arm.

Experimental: Dual-therapy arm

The dual-therapy group will be treated with the following treatments:

A) Approximately 8 weeks of Amlodipine 5mg and Lisinopril 20mg B) Approximately 8 weeks of Amlodipine 5mg and Chlortalidone 25mg C) Approximately 8 weeks of Lisinopril 20mg and Chlortalidone 25mg D) Approximately 8 weeks of Amiloride 10mg and Chlortalidone 25mg

Participants will be randomly allocated to one of four possible sequences of treatments of the four-treatment four-period Williams design: ABDC, BCAD, CDBA, and DACB.

Drug: Amlodipine
Amlodipine 5mg and Amlodipine 10mg will be one of the treatments in which patients will receive on the monotherapy arm and on the dual therapy arm.

Drug: Lisinopril

Lisinopril 10mg and Lisinopril 20mg will be one of the treatments in which patients will receive on the monotherapy arm.

Lisinopril 20mg will be one of the treatments in which patients will receive on the dual therapy arm.


Drug: Amiloride
Amiloride 10mg will be one of the treatments in which patients will receive on the dual therapy arm.

Drug: Chlortalidone
Chlortalidone 25mg will be one of the treatments in which patients will receive on the dual therapy arm and monotherapy arm.




Primary Outcome Measures :
  1. Seated Automated Office Systolic Blood Pressure [ Time Frame: Approximately 8 weeks after receiving each treatment up to week 24 for mono therapy patients and up to week 32 for dual therapy patients ]
    This is planned for all participants


Secondary Outcome Measures :
  1. Seated Automatic office systolic blood pressure [ Time Frame: At every visit - every 4 weeks up to week 24 for mono therapy patients and every 4 weeks up to week 32 for dual therapy patients. From screening until last visit. ]
    This is planned for all participants

  2. Core Cardiovascular Measurements [ Time Frame: Core cardiovascular measurements will be performed on all participants at Baseline. For all patients there is an option for them to have the measurements repeated at weeks 8, 16, 24 Mono&Dual and week 32 Dual only, these subsequent visits are optional. ]
    This is planned for all participants, but is only mandatory at baseline

  3. Detailed Self Defined Ethnicity [ Time Frame: Screening visit only ]
    This is planned for all participants

  4. Ambulatory Blood Pressure and/or blood pressure [ Time Frame: This will be measured for a subgroup of patients at Baseline, week 8, week 16, week 24 Dual&Mono & week 32 Dual only ]
    This is planned for a subgroup of patients who agree to participate in the sub-study

  5. Optional Cardiovascular measures [ Time Frame: These measurements will be performed on a subgroup of patients at Baseline, week 8, week 16, week 24 Dual&Mono & week 32 Dual only ]
    This is planned for a subgroup of patients who agree to participate in the sub-study


Other Outcome Measures:
  1. Baseline demographic comparison [ Time Frame: Baseline visit ]
    This is planned for all participants

  2. Urine compliance drug screen [ Time Frame: These will be measured for a subgroup of patients at Baseline visit, week 8, week 16, week 24 Dual&Mono & week 32 Dual only ]
    This is planned for a random subgroup of participants who are taking part in the sub-study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847338


Contacts
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Contact: Ella James 01223 349762 ella.james@addenbrookes.nhs.uk

Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Ella James    01223 349762      
Principal Investigator: Joseph Cheriyan         
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: Una Martin         
Sandwell & West Birmingham Hospitals NHS Trust Recruiting
Birmingham, United Kingdom, B18 7QH
Contact: Ronnie HAYNES    0121 507 5113    ronnie.haynes@nhs.net   
Contact: Rebecca Brown    0121 507 6657    Rebecca.brown15@nhs.net   
Principal Investigator: Gregory Lip         
University Hospital Llandough Recruiting
Cardiff, United Kingdom, CF64 2XX
Contact: Maggie Munnery    029 20416278    MMunnery@cardiffmet.ac.uk   
Contact: Barry McDonnell    029 206827    bmcdonnell@cardiffmet.ac.uk   
Principal Investigator: James Coulson         
University of Glasgow Recruiting
Glasgow, United Kingdom, G12 8TA
Principal Investigator: Sandosh Padmanabhan         
Leicester General Hospital Not yet recruiting
Leicester, United Kingdom, LE5 4PW
Principal Investigator: Kamlesh Khunti         
William Harvey Research Institute, Barts and the London Medical School Recruiting
London, United Kingdom, EC1M 6BQ
Principal Investigator: David Collier         
St. Thomas Hospital Recruiting
London, United Kingdom, SE1 7EH
Principal Investigator: Phil Chowienczyk         
Sub-Investigator: Luca Faconti         
Imperial College Healthcare NHS Trust St. Marys Hospital Not yet recruiting
London, United Kingdom, W2 1NY
Principal Investigator: Simon Thom         
University College London Not yet recruiting
London, United Kingdom, WC1E 7HB
Principal Investigator: Alun Hughes         
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Principal Investigator: Tony Heagerty         
Newcastle Hospital NHS Foundation Trust Not yet recruiting
Newcastle, United Kingdom, NE2 4HH
Principal Investigator: Simon Thomas         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Medical Research Council
Investigators
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Principal Investigator: Ian Wilkinson Cambridge University Hospitals NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Ian B Wilkinson, Consultant, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02847338     History of Changes
Other Study ID Numbers: AO94005
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only after the investigator has finished with the data and not patient identifiable data

Keywords provided by Dr Ian B Wilkinson, Cambridge University Hospitals NHS Foundation Trust:
Hypertension

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Lisinopril
Chlorthalidone
Amiloride
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing