Algorithm to predict blood pressure therapy
| ISRCTN | ISRCTN25916392 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25916392 |
| Secondary identifying numbers | EXP 2025 21826 |
- Submission date
- 17/03/2025
- Registration date
- 19/03/2025
- Last edited
- 03/04/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
High blood pressure is common in New Zealand and can lead to serious health problems like strokes and heart attacks. There are four main types of drugs used to treat high blood pressure, which affect the heart, kidneys, and blood vessels. Finding the right drug or combination of drugs is often a trial-and-error process, which can take many months or even over a year, leaving patients at risk during this time. This pilot study aims to test a new algorithm that uses genetic information from 14 genes related to blood pressure control to help choose the right drug more quickly. DNA will be collected from cheek swabs to see if the algorithm can make better drug choices based on patients' history of blood pressure response to different drugs.
Who can participate?
Participants with a diagnosis of hypertension for at least 1 year and up to 5 years who are attending Auckland-based GP practices involved in the study.
What does the study involve?
After providing written informed consent, volunteers will visit their GP practice to have two cheek swabs taken. Researchers will then review their medical records to gather demographic information and details about their history with blood pressure medications.
What are the possible benefits and risks of participating?
This study could help save time for both patients and GPs by finding the right blood pressure medication more quickly, potentially reducing healthcare costs and improving patient outcomes. As this is a pilot study, there may be unknown risks, but the process involves standard medical procedures like cheek swabs and chart reviews.
Where is the study run from?
University of Auckland (New Zealand)
When is the study starting and how long is it expected to run for?
March 2025 to April 2027
Who is funding the study?
The study is funded by the inaugural Partridge Family Research Laureate award (New Zealand)
Who is the main contact?
Prof Julian Paton (j.paton@auckland.ac.nz)
Contact information
Public, Scientific, Principal Investigator
85 Park Road
Faculty of Medical and Health Sciences
University of Auckland
Auckland
1142
New Zealand
 ORCID ID |
0000-0001-7410-2913 |
|---|---|
| Phone | +64 9 923 2052 |
| j.paton@auckland.ac.nz |
Study information
| Study design | Multi-centre retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Association between a pharmacogenomic algorithm to predict blood pressure therapy with blood pressure response to anti-hypertensive therapy: a retrospective pilot study |
| Study hypothesis | The specific aims of the pilot study are to: 1. Review blood pressure history together with prescribed medications noting efficaciousness of drugs used and time to control blood pressure in primary care patients with hypertension. 2. Obtain mouth swab samples for isolation of DNA from primary care patients with hypertension. 3. Determine if known single nucleotide polymorphisms on 11 genes related to blood pressure predict the most efficacious blood pressure lowering medication in patients with hypertension |
| Ethics approval(s) |
Approved 25/03/2025, Health and Disability Ethics Committee (Ministry of Health, 133 Molesworth Street, Wellington, 6011, New Zealand; -; hdecs@health.govt.nz), ref: EXP 2025 21826 |
| Condition | Hypertension |
| Intervention | This is a retrospective study of patient records. Clinic blood pressure measured using a non-invasive brachial artery blood pressure device. Patient notes will be reviewed for information regarding number and types of medications needed to control blood pressure, time to control, number of clinic visits to control, side effects from hypertension therapy, hypertension associated adverse events during treatment. Mouth swab samples will be obtained for isolation of DNA and identification of single nucleotide polymorphisms on 11 genes related to blood pressure. |
| Intervention type | Other |
| Primary outcome measure | Clinic blood pressure measured using a non-invasive brachial artery blood pressure device (e.g., oscilometric, auscultation) will be obtained by reviewing patient notes. |
| Secondary outcome measures | Obtained by reviewing patient notes: 1. Number and types of medications needed to control blood pressure 2. Time to control 3. Number of clinic visits to control 4. Side effects from hypertension therapy 5. Hypertension associated adverse events during treatment 6. Single nucleotide polymorphisms on 11 genes related to blood pressure will be determined from mouth swab samples |
| Overall study start date | 17/03/2025 |
| Overall study end date | 30/04/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Participant is able and willing to provide informed consent. 2. Participant is ≥20 and ≤50 years of age. 3. Participant with diagnosis of Hypertension for a minimum of 1 year and up to 5 years. 4. Participant has been on the same class/classes of blood pressure medication for a minimum of 6 months. 4.1. Note: A change in dosage, frequency, or specific medication is acceptable as long as there have been no changes to the class/classes of medications prescribed. 5. Participant is currently prescribed and taking one of the following classes of medications alone or in combination with each other: 5.1. Diuretics (thiazide or thiazide-like) 5.2. ACE Inhibitors 5.3. Angiotensin Receptor Blocker (ARB) 5.4. Beta-blockers 5.5. Ca2+ Channel Blockers 6. Evidence that the participant has regular GP visits and is compliant with medication (i.e., collects prescriptions). |
| Participant exclusion criteria | 1. Participant has a diagnosis of secondary hypertension or is pregnant. 2. Participant is currently prescribed and taking any additional class of medication(s) for high blood pressure not included in the list above 3. Participant has Systolic blood pressure >190 or Diastolic blood pressure >120 documented within the six months prior to visit. 4. Participant has co-morbidities such as heart failure, myocardial infarction and renal impairment. 5. Any other reason that the participant is inappropriate for study enrolment in the opinion of the Investigator. |
| Recruitment start date | 01/05/2025 |
| Recruitment end date | 30/04/2027 |
Locations
Countries of recruitment
- New Zealand
Study participating centres
Auckland
1050
New Zealand
Auckland
1072
New Zealand
Sponsor information
University/education
85 Park Road
Auckland
1142
New Zealand
| humanethics@auckland.ac.nz | |
| Website | https://www.auckland.ac.nz/en.html |
"ROR" |
https://ror.org/03b94tp07 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/05/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication of study results in high-impact scientific journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Julian Paton (j.paton@auckland.ac.nz) |
Editorial Notes
03/04/2025: The following changes were made to the trial record:
1. The recruitment start date was changed from 14/04/2025 to 01/05/2025.
2. The ethics approval was added.
3. The participant level data sharing statement was added.
18/03/2025: Trial's existence confirmed by Health and Disability Ethics Committee.
