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
Qualifiers
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
Treatments tested in this trial
- Amlodipine
- Olmesartan
- Hydrochlorothiazide
- Amlodipine/Olmesartan
Treatment groups
96 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov