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Completed

NCT Number: NCT04715698

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • office BP >= 140/90 mmHg
  • hypertensive patients who were treatment naive or previously treated with 1-3 anti-hypertensives
  • age 18-85, males or females
  • agree to sign informed consent

Exclusion criteria

  • having unstable hemodynamics diseases, or had myocardial infarction (MI), heart failure (HF) or chronic kidney disease (CKD) within previous 6 months
  • using large doses of diuretics or beta-blockers (usually refers to double max doses) and can not stop dosing
  • atrial fibrillation (AF) or severe arrhythmia
  • severe aortic regurgitation
  • severe thoracic fluids
  • height weight out of ranges: 120-230 cm30-230 kg
  • using more than 3 antihypertensives
  • known secondary hypertension
  • refused to sign informed consent

Treatment and study plan

ICG-guided drug selection

Other

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

empirical drug selection

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Shanghai Jiao Tong University School of Medicine
  • Yale University

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 20, 2021
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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