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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04715698
• Other study ID #: 20181201
• Status: Completed
• Phase: N/A
• Start date: December 31, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2021
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• ICG-guided drug selection
anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience
• empirical drug selection
anti-hypertensive drug selection based on physician's experience only

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Shanghai Jiao Tong University School of Medicine, Yale University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	BP control rate at 8 weeks	proportion of subjects with BP < 140/90 mmHg at 8 weeks post-baseline visit	8 weeks post-baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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