Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control

Study Overview
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Brief Summary
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A single-center, single-blind, randomized study to investigate the effectiveness of a hemodynamic-guided treatment strategy to improve blood pressure control

Detailed Description
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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.

Official Title
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Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control

Conditions
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Hypertension

Intervention / Treatment
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* Other: ICG-guided drug selection
* Other: empirical drug selection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG-guided<br>anti-hypertensive drug selection based on physician's experience and hemodynamic profiling by measured ICG | Other: ICG-guided drug selection<br>* anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience<br>|
| Active Comparator: Empirical<br>anti-hypertensive drug selection based on physician's experience only | Other: empirical drug selection<br>* anti-hypertensive drug selection based on physician's experience only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline systolic blood pressure at 8 weeks | Change from baseline systolic blood pressure at 8 weeks in the window of 4-12 weeks | 8 weeks post-baseline | 
| Change from baseline diastolic blood pressure at 8 weeks | Change from baseline diastolic blood pressure at 8 weeks in the window of 4-12 | 8 weeks post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP control rate at 8 weeks | proportion of subjects with BP < 140/90 mmHg at 8 weeks post-baseline visit | 8 weeks post-baseline | 
| Change from baseline heart rate (HR) at 8 weeks | Change from baseline heart rate (heart beats per minute) at 8 weeks in the window of 4-12 weeks | 8 weeks post-baseline | 
| Change from baseline cardiac index (CI) at 8 weeks | Change from baseline cardiac index (cardiac output devided by body surface area) at 8 weeks in the window of 4-12 weeks | 8 weeks post-baseline | 
| Change from baseline arterial stiffness (AS) at 8 weeks | Change from baseline arterial stiffness at 8 weeks in the window of 4-12 weeks | 8 weeks post-baseline | 
| Change from baseline systemic vascular resistance index (SVRI) at 8 weeks | Change from baseline systemic vascular resistance index at 8 weeks in the window of 4-12 weeks | 8 weeks post-baseline | 
| Change from baseline thoracic blood volume standing/supine ratio (TBR) at 8 weeks | Change from baseline thoracic blood volume standing vs supine ratio at 8 weeks in the window of 4-12 weeks | 8 weeks post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, ICG-guided, Hemodynamic profiling, Impedance cardiography