Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change from baseline diastolic blood pressure at 8 weeks
研究概览
简要总结
A single-center, single-blind, randomized study to investigate the effectiveness of a hemodynamic-guided treatment strategy to improve blood pressure control
详细描述
Hypertension is a hemodynamic-related disorder characterized by abnormalities of the cardiac output (CO) and/or systemic vascular resistance (SVR). It is hypothesized that selecting antihypertensive therapy based on patients' hemodynamic profile could lead to more effective blood pressure (BP) control than standard care in a real-world population of hypertensive patients in outpatient setting. A single-center, randomized trial was conducted to include adults with uncontrolled hypertension who seek outpatient care at Peking University People's Hospital between December 2018 and December 2019 in Beijing, China.
Participants were randomly assigned to the standard care group or the hemodynamic group in a 1:1 ratio. Impedance cardiography (ICG) was performed with all participants to measure hemodynamic parameters. Only physicians in the hemodynamic group were provided with patients' ICG findings and a computerized clinical decision support of recommended treatment choices based on patients' hemodynamic profiles. The primary outcomes were the reductions in systolic BP (SBP) and diastolic BP (DBP) levels at the follow-up visit 8(±4) weeks after baseline. Secondary outcomes included achievement of BP goal of <140/ 90 mmHg and the reductions in BP by baseline BP, age, sex, and BMI.
The ICG device used (HDproTM CHM T3002/P3005, designed by Beijing Li-Heng Medical Technologies, Ltd, manufactured by Shandong Baolihao Medical Appliances, Ltd.) was developed based on improved hardware and advanced digital filtering algorithms, and has been validated versus both invasive thermodilution and non-invasive echocardiography in different settings.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •office BP >= 140/90 mmHg
- •hypertensive patients who were treatment naive or previously treated with 1-3 anti-hypertensives
- •age 18-85, males or females
- •agree to sign informed consent
排除标准
- •having unstable hemodynamics diseases, or had myocardial infarction (MI), heart failure (HF) or chronic kidney disease (CKD) within previous 6 months
- •using large doses of diuretics or beta-blockers (usually refers to double max doses) and can not stop dosing
- •atrial fibrillation (AF) or severe arrhythmia
- •severe aortic regurgitation
- •severe thoracic fluids
- •height weight out of ranges: 120-230 cm30-230 kg
- •using more than 3 antihypertensives
- •known secondary hypertension
- •refused to sign informed consent
结局指标
主要结局
Change from baseline diastolic blood pressure at 8 weeks
时间窗: 8 weeks post-baseline
Change from baseline diastolic blood pressure at 8 weeks in the window of 4-12
Change from baseline systolic blood pressure at 8 weeks
时间窗: 8 weeks post-baseline
Change from baseline systolic blood pressure at 8 weeks in the window of 4-12 weeks
次要结局
- Change from baseline thoracic blood volume standing/supine ratio (TBR) at 8 weeks(8 weeks post-baseline)
- Change from baseline systemic vascular resistance index (SVRI) at 8 weeks(8 weeks post-baseline)
- BP control rate at 8 weeks(8 weeks post-baseline)
- Change from baseline heart rate (HR) at 8 weeks(8 weeks post-baseline)
- Change from baseline cardiac index (CI) at 8 weeks(8 weeks post-baseline)
- Change from baseline arterial stiffness (AS) at 8 weeks(8 weeks post-baseline)
研究者
Ningling Sun
Director of Hypertension Department at Heart Center
Peking University People's Hospital