Clinical trial NCT04715698: Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control
Official title: Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
ICG-guided
Hemodynamic profiling
Impedance cardiography
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Yale University
name: Shanghai Jiao Tong University School of Medicine
First posted: 2021-01-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline systolic blood pressure at 8 weeks
timeFrame: 8 weeks post-baseline
measure: Change from baseline diastolic blood pressure at 8 weeks
timeFrame: 8 weeks post-baseline
Secondary outcomes:
measure: BP control rate at 8 weeks
timeFrame: 8 weeks post-baseline
measure: Change from baseline heart rate (HR) at 8 weeks
timeFrame: 8 weeks post-baseline
measure: Change from baseline cardiac index (CI) at 8 weeks
timeFrame: 8 weeks post-baseline
measure: Change from baseline arterial stiffness (AS) at 8 weeks
timeFrame: 8 weeks post-baseline
measure: Change from baseline systemic vascular resistance index (SVRI) at 8 weeks
timeFrame: 8 weeks post-baseline
measure: Change from baseline thoracic blood volume standing/supine ratio (TBR) at 8 weeks
timeFrame: 8 weeks post-baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Department of Hypertension at Heart Centr, Peking University People's Hospital, Beijing, China
name: Ningling Sun
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.