RecruitingPhase 4NCT05917275

Multi-Omics to Predict the Blood Pressure Response to Antihypertensives


Sponsor

Radboud University Medical Center

Enrollment

96 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

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, 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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using a comprehensive biological analysis (genes, gut bacteria, blood markers) to figure out which blood pressure medication works best for which individual — a step toward personalized hypertension treatment. **You may be eligible if...** - You are 18–75 years old - You have grade 1–2 high blood pressure (systolic 130–164 mmHg on 24-hour monitoring) - You are not currently on blood pressure medication, or you are on a single medication and willing to stop it for 4 weeks to allow a clean baseline **You may NOT be eligible if...** - You have severely high blood pressure or secondary hypertension (caused by a specific underlying disease) - You have significant heart, kidney, or liver disease - You are currently pregnant - You have had a heart attack or stroke in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmlodipine

4 weeks of Amlodipine

DRUGOlmesartan

4 weeks of Olmesartan

DRUGHydrochlorothiazide

4 weeks of Hydrochlorothiazide

DRUGAmlodipine/Olmesartan

4 weeks of Amlodipine/Olmesartan


Locations(1)

Radboudumc

Nijmegen, Netherlands

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NCT05917275


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