NCT04715698

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	ICG-guided drug selection	anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience
OTHER	empirical drug selection	anti-hypertensive drug selection based on physician's experience only

Timeline

• Start date: 2018-12-31
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2021-01-20
• Last updated: 2021-01-20

Locations

1 site across 1 country: China