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

NCT ID: NCT04715698

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2019-12-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ICG-guided

anti-hypertensive drug selection based on physician's experience and hemodynamic profiling by measured ICG

Group Type: EXPERIMENTAL

ICG-guided drug selection

Intervention Type: OTHER

anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience

Empirical

anti-hypertensive drug selection based on physician's experience only

Group Type: ACTIVE_COMPARATOR

empirical drug selection

Intervention Type: OTHER

anti-hypertensive drug selection based on physician's experience only

Interventions

ICG-guided drug selection

anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience

Intervention Type: OTHER

empirical drug selection

anti-hypertensive drug selection based on physician's experience only

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ningling Sun

Director of Hypertension Department at Heart Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ningling Sun

Role: PRINCIPAL_INVESTIGATOR

Department of Hypertension at Heart Centr, Peking University People's Hospital, Beijing, China

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34580169 (View on PubMed)

Other Identifiers

20181201

Identifier Type: -

Identifier Source: org_study_id