Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
ConditionPrimary Hypertension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Amlodipine
Drug4 weeks of Amlodipine
Olmesartan
Drug4 weeks of Olmesartan
Hydrochlorothiazide
Drug4 weeks of Hydrochlorothiazide
Amlodipine/Olmesartan
Drug4 weeks of Amlodipine/Olmesartan
Treatment groups
96 Participants
are divided into 4 treatment groupsGroup A: 4 weeks of AmlodipineExperimental treatment 1 intervention
Group B: 4 weeks of OlmesartanExperimental treatment 1 intervention
Group C: 4 weeks of HydrochlorothiazideExperimental treatment 1 intervention
Group D: 4 weeks of Amlodipine/OlmesartanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
4 weeks after start treatmentSecondary outcomes
1
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).
Time frame
4 weeks after start treatment2
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
Time frame
correlation between changes from baseline to 4 weeks after start treatmentOther outcomes
1
Changes in Multi-Omics profile after treatment
Change in individual Multi-Omics profile components after treatment with olmesartan, amlodipine and hydrochlorothiazide compared with biomarkers levels at baseline.
Time frame
4 weeks after start treatmentSponsors and contacts
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Source ClinicalTrials.gov