Primary HypertensionPhase 4HT-PREDICTNCT05917275
Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
A Phase 4 study testing Amlodipine, Olmesartan and Hydrochlorothiazide in people with Primary Hypertension, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to develop biomarkers composed of multiple OMICs (MOMICs) for prediction of blood pressure response to antihypertensive drugs in the treatment of primary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Amlodipine, Olmesartan and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Apr 2024to Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 up to and including 75 years
- 24 hours systolic blood pressure 130-164 (corresponding with grade 1-2 hypertension), without the use of blood pressure lowering agents (at screening for patients without pre-treatment or after 4 week wash-out of antihypertensive medication for subjects using a single antihypertensive agent at screening)
- Indication for antihypertensive therapy according to the 2023 European Society of Hypertension Guidelines for the management of arterial hypertension
- Subject is not treated with antihypertensive drugs or is treated with a single antihypertensive drug.
- Female patients must be non-lactating and at no risk of pregnancy for one of the following reasons: 1 year postmenopausal, surgically sterile, or willing to use an acceptable method of contraception (oral contraceptives, approved contraceptive implants, long-term injectable contraception, intrauterine devices, or tubal ligation are allowed.)
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Treatment with 2 or more antihypertensive drugs < 3 months before inclusion. It is not allowed to stop medication for study purposes in subjects treated with 2 or more anti-hypertensive drugs.
- Known diagnosis of secondary hypertension to an identifiable cause other than treated sleep apnea (e.g., hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, uncontrolled hyper- or hypothyroidism and intracranial tumor)
- Use of VEGF inhibitors, calcineurin inhibitors, glucocorticosteroids, erythropoietin stimulation agents, daily use of NSAID's
- Use of MDMA, methamphetamine, cocaine
- Use of glycyrrhetinic acid containing products , i.e. liquorice, specific herbal teas, <4 weeks before inclusion. (If patients are willing to stop the intake of glycyrrhetinic acid containing products for the duration of the trial, they can be rescreened after 4 weeks of stopping glycyrrhetinic acid containing products)
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- Use of potassium containing supplements
- Concurrent use of medication or a supplement with significant drug interaction with study medication. Special attention is warranted for amlodipine which is metabolized by Cyp3A4. Subjects using strong inhibitors or inducers of Cyp3A4 are excluded from participation in this trial. A list of strong inhibitors and inducers is provided in Addendum 1 of this protocol. For information on possible drug interactions we refer to the website of Lexi-Interact Online (Lexicomp® Drug Interactions - UpToDate (doctorabad.com): https://doctorabad.com/UpToDate/d/di.htm).
- History of myocardial infarction, angina pectoris
- History of atrial fibrillation
- History of severe valvular or structural heart disease (excluding left ventricular hypertrophy)
- History of NYHA class III or IV heart failure or known reduced left ventricular function (ejection fraction (EF) <30%)
- History of cerebrovascular accident or transient ischemic attack
- History of hypertensive crisis
- History of liver failure
- History of skin cancer
- History of gout
- Current hyperparathyroidism
- Current biliary tract obstruction
- Pregnancy
- Life expectancy < 1 year
- Known side effect or contra-indication to treatment with calcium channel blockers
- Known side effect or contra-indication to treatment with angiotensin II receptor blockers
- Known side effect or contra-indication to treatment with thiazide diuretics
- Arm circumference > 46 cm
- Sodium level outside reference range at screening visit
- Potassium level outside reference range at screening visit
- Calcium level outside reference range at screening visit
- eGFR < 50 ml/min/1,73m2
- Use of loop diuretics.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to develop biomarkers composed of multiple OMICs (MOMICs) for prediction of blood pressure response to antihypertensive drugs in the treatment of primary hypertension. The main objectives are:
- Primary objective:
- To identify MOMICs biomarkers that predict the response in 24-hour blood pressure to antihypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine)
- Secondary objectives:
- To identify a MOMICs biomarker that predict the response in night-time blood pressure to anti-hypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine)
- To identify MOMICs biomarkers that predict side effects, including changes in QoLof olmesartan, amlodipine and hydrochlorothiazide.
- Exploratory objective:
- To assess changes in MOMICs biomarkers induced by each drug
Read more
Participants will undergo three 4-week treatment periods:
- Each subject receives 3 out of 4 possible treatments (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine).
- Before and after each treatment period OMICS measurements and an ABPM are performed.
- At the end of each treatment period blood is sampled for drug level testing to assess adherence.
- Electrolytes and kidney function are checked 5-7 days after start of each treatment period.
- Conditions
- Primary Hypertension
- Being tested
- Amlodipine, Olmesartan, Hydrochlorothiazide, Amlodipine/Olmesartan
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
4 weeks of Amlodipine
OlmesartanDrug
4 weeks of Olmesartan
HydrochlorothiazideDrug
4 weeks of Hydrochlorothiazide
Amlodipine/OlmesartanDrug
4 weeks of Amlodipine/Olmesartan
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks of Amlodipine | Experimental | Not described Receives: Drug: Amlodipine |
| 4 weeks of Olmesartan | Experimental | Not described Receives: Drug: Olmesartan |
| 4 weeks of Hydrochlorothiazide | Experimental | Not described Receives: Drug: Hydrochlorothiazide |
| 4 weeks of Amlodipine/Olmesartan | Experimental | Not described Receives: Drug: Amlodipine/Olmesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of Multi-Omics profile for blood pressure
Predictive value of a MOMICs profile to discriminate subjects with a decrease in 24-hour blood pressure below the median from subjects with a decrease in 24-hour blood pressure above the median for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine).
Measured: 4 weeks after start treatment
Secondary outcomes (2)
Predictive value of Multi-Omics profile for night-time blood pressure
Predictive value of a MOMICs profile to discriminate subjects with a decrease in night-time blood pressure below the median from subjects with a decrease in 24-hour blood pressure above the median, for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine).
Measured: 4 weeks after start treatment
Correlation Multi-Omics profile and adverse effects
Correlation between changes in individual biomarkers and adverse effects as documented using adverse effects questionnaire and SF-36
Measured: correlation between changes from baseline to 4 weeks after start treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start4 Apr 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joost Rutten, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917275
- Sponsor's protocol ID
- 114516
- Other IDs
- 2023-505239-10-00, 2023
- Acronym
- HT-PREDICT
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2023
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
- ClinicalTrials.gov ID
- NCT05917275
- Acronym / sponsor ID
- HT-PREDICT / 114516
- Conditions
- Primary Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to develop biomarkers composed of multiple OMICs (MOMICs) for prediction of blood pressure response to antihypertensive drugs in the treatment of primary hypertension. The main objectives are:
- Primary objective:
- To identify MOMICs biomarkers that predict the response in 24-hour blood pressure to antihypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine)
- Secondary objectives:
- To identify a MOMICs biomarker that predict the response in night-time blood pressure to anti-hypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine)
- To identify MOMICs biomarkers that predict side effects, including changes in QoLof olmesartan, amlodipine and hydrochlorothiazide.
- Exploratory objective:
- To assess changes in MOMICs biomarkers induced by each drug
Participants will undergo three 4-week treatment periods:
- Each subject receives 3 out of 4 possible treatments (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine).
- Before and after each treatment period OMICS measurements and an ABPM are performed.
- At the end of each treatment period blood is sampled for drug level testing to assess adherence.
- Electrolytes and kidney function are checked 5-7 days after start of each treatment period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4 weeks of Amlodipine | Experimental | Drug: Amlodipine |
| 4 weeks of Olmesartan | Experimental | Drug: Olmesartan |
| 4 weeks of Hydrochlorothiazide | Experimental | Drug: Hydrochlorothiazide |
| 4 weeks of Amlodipine/Olmesartan | Experimental | Drug: Amlodipine/Olmesartan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 up to and including 75 years
- 24 hours systolic blood pressure 130-164 (corresponding with grade 1-2 hypertension), without the use of blood pressure lowering agents (at screening for patients without pre-treatment or after 4 week wash-out of antihypertensive medication for subjects using a single antihypertensive agent at screening)
- Indication for antihypertensive therapy according to the 2023 European Society of Hypertension Guidelines for the management of arterial hypertension
- Subject is not treated with antihypertensive drugs or is treated with a single antihypertensive drug.
- Female patients must be non-lactating and at no risk of pregnancy for one of the following reasons: 1 year postmenopausal, surgically sterile, or willing to use an acceptable method of contraception (oral contraceptives, approved contraceptive implants, long-term injectable contraception, intrauterine devices, or tubal ligation are allowed.)
Key exclusion criteria (30 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Treatment with 2 or more antihypertensive drugs < 3 months before inclusion. It is not allowed to stop medication for study purposes in subjects treated with 2 or more anti-hypertensive drugs.
- Known diagnosis of secondary hypertension to an identifiable cause other than treated sleep apnea (e.g., hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, uncontrolled hyper- or hypothyroidism and intracranial tumor)
- Use of VEGF inhibitors, calcineurin inhibitors, glucocorticosteroids, erythropoietin stimulation agents, daily use of NSAID's
- Use of MDMA, methamphetamine, cocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine4 weeks of Amlodipine | Drug | 4 weeks of Amlodipine |
| Olmesartan4 weeks of Olmesartan | Drug | 4 weeks of Olmesartan |
| Hydrochlorothiazide4 weeks of Hydrochlorothiazide | Drug | 4 weeks of Hydrochlorothiazide |
| Amlodipine/Olmesartan4 weeks of Amlodipine/Olmesartan | Drug | 4 weeks of Amlodipine/Olmesartan |
Primary outcome
Predictive value of Multi-Omics profile for blood pressure
Time frame: 4 weeks after start treatment
Predictive value of a MOMICs profile to discriminate subjects with a decrease in 24-hour blood pressure below the median from subjects with a decrease in 24-hour blood pressure above the median for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine).
2 secondary outcomes
Predictive value of Multi-Omics profile for night-time blood pressure
Time frame: 4 weeks after start treatment
Correlation Multi-Omics profile and adverse effects
Time frame: correlation between changes from baseline to 4 weeks after start treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost Rutten principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine, Olmesartan and Hydrochlorothiazide in people with Primary Hypertension, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Internal Medicine Secretary (+31243618819, secretariaatstaf.aig@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of Multi-Omics profile for blood pressure (time frame: 4 weeks after start treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.