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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: ICG-guided drug selection; Other: empirical drug selection

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Yale University; Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Ningling Sun, Department of Hypertension at Heart Centr, Peking University People's Hospital, Beijing, China

Publications and helpful links

General Publications

• Lu Y, Wang L, Wang H, Gu J, Ma ZJ, Lian Z, Zhang Z, Krumholz H, Sun N. Effectiveness of an impedance cardiography guided treatment strategy to improve blood pressure control in a real-world setting: results from a pragmatic clinical trial. Open Heart. 2021 Sep;8(2):e001719. doi: 10.1136/openhrt-2021-001719. Erratum In: Open Heart. 2021 Oct;8(2): Open Heart. 2021 Nov;8(2):

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 16, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Impedance cardiography; ICG-guided; Hemodynamic profiling
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 20181201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No