NCT07240909尚未招募4 期
A Multicenter, Randomized, PROBE Trial on Antihypertensive Drug Selection Based on Hemodynamic Phenotypes Defined by Bioelectrical Impedance Analysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Difference in office systolic blood pressure reduction
研究概览
简要总结
The goal of this clinical trial is to explore the clinical efficacy and safety of individualized antihypertensive medication guided by hemodynamic phenotyping. The main questions it aims to answer are:
- Does hemodynamics-based individualized antihypertensive therapy achieve better blood pressure control compared to guideline-based conventional therapy?
- Does hemodynamics-based individualized therapy have comparable safety to guideline-based conventional treatment? Researchers will compare hemodynamics-based individualized antihypertensive therapy to guideline-based conventional treatment to see if the former is better than the latter.
Participants will:
- Take hemodynamics-based individualized antihypertensive therapy or guideline-based conventional treatment every day for 8 weeks
- Visit the clinic once every 4 weeks for checkups and tests
- Keep a diary of their symptoms and any treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥30 and <80 years, regardless of gender;
- •Confirmed diagnosis of hypertension meeting the criteria outlined in the 2024 Chinese Hypertension Guidelines: office blood pressure ≥140/90 mmHg and home blood pressure ≥135/85 mmHg;
- •Mild to moderate hypertension, with office blood pressure ranging from 140-179/90-109 mmHg;
- •No prior use of antihypertensive medications;
- •Voluntary participation in the study with written informed consent obtained.
排除标准
- •Diagnosed or highly suspected secondary hypertension;
- •Classified as mixed type according to hemodynamic typing;
- •Allergy to the intended antihypertensive medications;
- •Pregnant or lactating women;
- •Potential pregnancy plans during the trial period;
- •Uncorrected electrolyte disturbances;
- •Severe organ dysfunction;
- •Comorbid conditions leading to inaccurate blood pressure measurement;
- •Comorbid conditions or states unsuitable for noninvasive hemodynamic measurement via bioelectrical impedance;
- •Comorbid conditions contraindicating or requiring caution with trial medications;
- •Comorbid conditions affecting the absorption, distribution, metabolism, or excretion of trial drugs;
- •Concurrent or planned use of medications contraindicated or requiring caution with trial drugs;
- •Concurrent or planned use of medications interfering with trial outcomes;
- •Clinician's assessment deems the patient unsuitable for the trial's antihypertensive regimen;
- •Current participation in other clinical studies that may interfere with the conduct of this trial.
研究组 & 干预措施
hemodynamics-based individualized antihypertensive therapy
Experimental
The antihypertensive strategy is individualized according to the patient's hemodynamic indices:
High-resistance type: Amlodipine Besylate Tablets 5mg, once daily, orally. High cardiac output type: Metoprolol Sustained-Release Tablets 47.5mg, once daily, orally.
Hypervolemic type: Indapamide Tablets 2.5mg, once daily, orally.
干预措施: hemodynamics-based individualized antihypertensive therapy (Drug)
guideline-based conventional therapy
Active Comparator
Developing a monotherapy antihypertensive treatment plan for participants based on the 2024 Chinese hypertension guidelines
干预措施: guideline-based conventional treatment (Drug)
结局指标
主要结局
Difference in office systolic blood pressure reduction
时间窗: 8 weeks after treatment
Difference in office systolic blood pressure reduction between two groups.
次要结局
- Reduction difference in office systolic blood pressure(4 weeks after treatment)
- Reduction difference in office diastolic blood pressure(8 weeks after treatment)
- Reduction difference in office mean blood pressure(8 weeks after treatment)
- Difference in pulse rate changes(8 weeks after treatment)
- Difference in blood pressure target rate(8 weeks after treatment)
- Difference of systemic vascular resistance index (SVRI) changes(8 weeks after treatment)
- Difference of cardiac index (CI) changes(8 weeks after treatment)
- Difference of thoracic fluid content (TFC) changes(8 weeks after treatment)
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