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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: ICG-guided drug selection; Other: empirical drug selection

• Registration Number: NCT04715698
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-12-31
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-16
• Last Update Submitted: 2021-01-16
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. office BP >= 140/90 mmHg
2. hypertensive patients who were treatment naive or previously treated with 1-3 anti-hypertensives
3. age 18-85, males or females
4. agree to sign informed consent

Exclusion Criteria

1. having unstable hemodynamics diseases, or had myocardial infarction (MI), heart failure (HF) or chronic kidney disease (CKD) within previous 6 months
2. using large doses of diuretics or beta-blockers (usually refers to double max doses) and can not stop dosing
3. atrial fibrillation (AF) or severe arrhythmia
4. severe aortic regurgitation
5. severe thoracic fluids
6. height weight out of ranges: 120-230 cm30-230 kg
7. using more than 3 antihypertensives
8. known secondary hypertension
9. refused to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICG-guided	ICG-guided drug selection	anti-hypertensive drug selection based on physician's experience and hemodynamic profiling by measured ICG
Empirical	empirical drug selection	anti-hypertensive drug selection based on physician's experience only

Primary Outcome Measures

Name	Time	Method
Change from baseline diastolic blood pressure at 8 weeks	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	8 weeks post-baseline	Change from baseline systolic blood pressure at 8 weeks in the window of 4-12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China