Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Predictive value of Multi-Omics profile for blood pressure
研究概览
简要总结
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)
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To identify MOMICs biomarkers that predict side effects, including changes in QoLof olmesartan, amlodipine and hydrochlorothiazide.
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Exploratory objective:
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
4 weeks of Amlodipine
干预措施: Amlodipine (Drug)
4 weeks of Olmesartan
干预措施: Olmesartan (Drug)
4 weeks of Hydrochlorothiazide
干预措施: Hydrochlorothiazide (Drug)
4 weeks of Amlodipine/Olmesartan
干预措施: Amlodipine/Olmesartan (Drug)
结局指标
主要结局
Predictive value of Multi-Omics profile for blood pressure
时间窗: 4 weeks after start treatment
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).
次要结局
- Correlation Multi-Omics profile and adverse effects(correlation between changes from baseline to 4 weeks after start treatment)
- Predictive value of Multi-Omics profile for night-time blood pressure(4 weeks after start treatment)