Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
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 b
| Condition(s) | Primary Hypertension |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. 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, amlodip |
| Who can participate | Inclusion criteria * 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 me |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Radboud University Medical Center |
| Locations | Nijmegen, Netherlands |
| Start date | 2024-04-04 |
| NCT ID | NCT05917275 |
| Official listing | https://clinicaltrials.gov/study/NCT05917275 |