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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
96
4 weeks of Amlodipine
4 weeks of Olmesartan
4 weeks of Hydrochlorothiazide
4 weeks of Amlodipine/Olmesartan
Radboudumc
Nijmegen, Netherlands
RECRUITINGPredictive 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 treatment
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 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
Time frame: correlation between changes from baseline to 4 weeks after start treatment
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