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

• ClinicalTrials.gov Identifier: NCT04715698
• Recruitment Status: Completed
• First Posted: January 20, 2021
• Last Update Posted: January 20, 2021
• Sponsor: Peking University People's Hospital
• Collaborators: Yale University; Shanghai Jiao Tong University School of Medicine
• Information provided by (Responsible Party): Ningling Sun, Peking University People's Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hypertension	Other: ICG-guided drug selection; Other: empirical drug selection	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control
• Actual Study Start Date: December 31, 2018
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline systolic blood pressure at 8 weeks [ Time Frame: 8 weeks post-baseline ]
   Change from baseline systolic blood pressure at 8 weeks in the window of 4-12 weeks
2. Change from baseline diastolic blood pressure at 8 weeks [ Time Frame: 8 weeks post-baseline ]
   Change from baseline diastolic blood pressure at 8 weeks in the window of 4-12

Secondary Outcome Measures :

1. BP control rate at 8 weeks [ Time Frame: 8 weeks post-baseline ]
   proportion of subjects with BP < 140/90 mmHg at 8 weeks post-baseline visit
2. Change from baseline heart rate (HR) at 8 weeks [ Time Frame: 8 weeks post-baseline ]
   Change from baseline heart rate (heart beats per minute) at 8 weeks in the window of 4-12 weeks
3. Change from baseline cardiac index (CI) at 8 weeks [ Time Frame: 8 weeks post-baseline ]
   Change from baseline cardiac index (cardiac output devided by body surface area) at 8 weeks in the window of 4-12 weeks
4. Change from baseline arterial stiffness (AS) at 8 weeks [ Time Frame: 8 weeks post-baseline ]
   Change from baseline arterial stiffness at 8 weeks in the window of 4-12 weeks
5. Change from baseline systemic vascular resistance index (SVRI) at 8 weeks [ Time Frame: 8 weeks post-baseline ]
   Change from baseline systemic vascular resistance index at 8 weeks in the window of 4-12 weeks
6. Change from baseline thoracic blood volume standing/supine ratio (TBR) at 8 weeks [ Time Frame: 8 weeks post-baseline ]
   Change from baseline thoracic blood volume standing vs supine ratio at 8 weeks in the window of 4-12 weeks

Eligibility Criteria

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

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

Contacts and Locations

Locations

China

Peking University People's Hospital

Beijing, China

Sponsors and Collaborators

Peking University People's Hospital

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: e001719. doi: 10.1136/openhrt-2021-001719. Erratum in: Open Heart. 2021 Oct;8(2):. Open Heart. 2021 Nov;8(2):.

• Responsible Party: Ningling Sun, Director of Hypertension Department at Heart Center, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT04715698
• Other Study ID Numbers: 20181201
• First Posted: January 20, 2021
• Last Update Posted: January 20, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ningling Sun, Peking University People's Hospital:

Hypertension; ICG-guided; Hemodynamic profiling; Impedance cardiography

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases