HypertensionNCT04715698
Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control
A study testing ICG-guided drug selection and empirical drug selection in people with Hypertension, run by Peking University People's Hospital at 1 site in China.
Trial summary
A single-center, single-blind, randomized study to investigate the effectiveness of a hemodynamic-guided treatment strategy to improve blood pressure control Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ICG-guided drug selection and empirical drug selection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- using more than 3 antihypertensives
- known secondary hypertension
- refused to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
A single-center, single-blind, randomized study to investigate the effectiveness of a hemodynamic-guided treatment strategy to improve blood pressure control
Read the 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
- Being tested
- ICG-guided drug selection, empirical drug selection
- Keywords
- Hypertension, ICG-guided, Hemodynamic profiling, Impedance cardiography
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-guided drug selectionOther
anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience
empirical drug selectionOther
anti-hypertensive drug selection based on physician's experience only
| Study group | Role | What they receive |
|---|---|---|
| ICG-guided | Experimental | anti-hypertensive drug selection based on physician's experience and hemodynamic profiling by measured ICG Receives: Other: ICG-guided drug selection |
| Empirical | Active comparator | anti-hypertensive drug selection based on physician's experience only Receives: Other: empirical drug selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks post-baseline
Change from baseline diastolic blood pressure at 8 weeks
Change from baseline diastolic blood pressure at 8 weeks in the window of 4-12
Measured: 8 weeks post-baseline
Secondary outcomes (6)
BP control rate at 8 weeks
proportion of subjects with BP < 140/90 mmHg at 8 weeks post-baseline visit
Measured: 8 weeks post-baseline
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
Measured: 8 weeks post-baseline
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
Measured: 8 weeks post-baseline
Change from baseline arterial stiffness (AS) at 8 weeks
Change from baseline arterial stiffness at 8 weeks in the window of 4-12 weeks
Measured: 8 weeks post-baseline
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
Measured: 8 weeks post-baseline
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
Measured: 8 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start31 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ningling Sun, Peking University People's Hospital
- Investigators
- Ningling Sun, Principal investigator, Department of Hypertension at Heart Centr, Peking University People's Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715698
- Sponsor's protocol ID
- 20181201
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34580169
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of A Hemodynamic-Guided Treatment Strategy to Improve Blood Pressure Control
- ClinicalTrials.gov ID
- NCT04715698
- Acronym / sponsor ID
- 20181201
- Conditions
- Hypertension
- Keywords
- Hypertension, ICG-guided, Hemodynamic profiling, Impedance cardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Yale University, Shanghai Jiao Tong University School of Medicine
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG-guided | Experimental | Other: ICG-guided drug selectionanti-hypertensive drug selection based on physician's experience and hemodynamic profiling by measured ICG |
| Empirical | Active comparator | Other: empirical drug selectionanti-hypertensive drug selection based on physician's experience only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG-guided drug selectionanti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience | Other | ICG-guided |
| empirical drug selectionanti-hypertensive drug selection based on physician's experience only | Other | Empirical |
Primary outcome
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
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
6 secondary outcomes
BP control rate at 8 weeks
Time frame: 8 weeks post-baseline
Change from baseline heart rate (HR) at 8 weeks
Time frame: 8 weeks post-baseline
Change from baseline cardiac index (CI) at 8 weeks
Time frame: 8 weeks post-baseline
Change from baseline arterial stiffness (AS) at 8 weeks
Time frame: 8 weeks post-baseline
Change from baseline systemic vascular resistance index (SVRI) at 8 weeks
Time frame: 8 weeks post-baseline
Change from baseline thoracic blood volume standing/supine ratio (TBR) at 8 weeks
Time frame: 8 weeks post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 34580169Lu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ningling Sun principal investigator
Department of Hypertension at Heart Centr, Peking University People's Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG-guided drug selection and empirical drug selection in people with Hypertension, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline systolic blood pressure at 8 weeks (time frame: 8 weeks post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.