An interventional study of ICG-guided drug selection and empirical drug selection in Hypertension, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
A single-center, single-blind, randomized study to investigate the effectiveness of a hemodynamic-guided treatment strategy to improve blood pressure control
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 102 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Exclusion Criteria:
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 physician's experience only
Other: empirical drug selection
anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience
anti-hypertensive drug selection based on physician's experience only
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
Time frame: 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
Time frame: 8 weeks post-baseline
BP control rate at 8 weeks
proportion of subjects with BP \< 140/90 mmHg at 8 weeks post-baseline visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks post-baseline
Plan to share: No
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital