Cardiac risk factors and prevention

Effectiveness of an impedance cardiography guided treatment strategy to amend blood pressure control in a real-world setting: results from a pragmatic clinical trial

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  1. Luyan Wangane,
  2. http://orcid.org/0000-0001-5264-2169Yuan Lu2,3,
  3. Hongyi Wang1,
  4. Jianlei Guiv,5,
  5. Zheng J Maiv,half-dozen,
  6. Zheng Lian6,
  7. Zhiying Zhang7,
  8. Harlan Krumholz3,8 and
  9. Ningling Sun1
  1. 1 Department of Cardiology and Hypertension, Peking Academy People's Hospital, Beijing, China
  2. 2 Section of Cardiovascular Medicine, Section of Internal Medicine, Yale Schoolhouse of Medicine, New Haven, Connecticut, United states of america
  3. iii Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA
  4. 4 SJTU-Yale Joint Center for Biostatistics, Shanghai Jiao Tong Academy, Shanghai, China
  5. 5 Shanghai Engineering Research Centre for Big Data in Pediatric Precision Medicine, Shanghai, China
  6. 6 Section of Research & Development, Beijing Li-Heng Medical Technologies, Ltd, Beijing, Cathay
  7. 7 Department of Cardiology, Beijing Tiantan Puhua Hospital, Beijing, China
  8. eight Section of Health Policy and Direction, Yale Schoolhouse of Medicine, New Haven, Connecticut, The states
  1. Correspondence to Dr Ningling Lord's day; sunnl{at}263.net

Abstract

Objective To test the effectiveness of an impedance cardiography (ICG) guided treatment strategy on improving blood pressure (BP) control in real-earth clinical practice.

Design A single-centre, businesslike randomised trial.

Setting A hypertension clinic of the Peking Academy People'due south Hospital in Beijing, China.

Participants Adults who sought outpatient care for hypertension in the hypertension clinic at the Peking University People's Hospital between June and Dec 2019.

Interventions A computerised clinical decision support of recommending treatment choices to providers based on patients' haemodynamic profiles measured by ICG.

Main outcome measures Changes in systolic BP (SBP) and diastolic BP (DBP) levels at the follow-upward visit 4–12 weeks after baseline. Secondary outcomes included accomplishment of BP goal of <140/90 mm Hg and the changes in BP by baseline BP, age, sexual practice and torso mass index (BMI).

Results A total of 102 adults (hateful historic period was 54±xiv years; 41% were women) completed the study. The mean baseline SBP was 150.ix (SD of 11.5) mm Hg and mean baseline DBP was 91.i (11.3) mm Hg. At the follow-up visit, the mean SBP and DBP decreased past 19.9 and 11.iii mm Hg in the haemodynamic group, as compared with 12.0 and iv.nine mm Hg in the standard intendance grouping (p value for difference between groups <0.001). The proportion of patients achieving BP goal of <140/90 mm Hg in the haemodynamic group was 67%, as compared with 41% in the standard care group (p=0.017). The haemodynamic group had a larger upshot on BP reduction consistently across subgroups by age, sex, BMI and baseline BP.

Conclusions An ICG-guided treatment strategy led to greater reductions in BP levels than were observed with standard care in a real-world population of outpatients with hypertension. There is a need for further validation of this strategy for improving blood pressure treatment selection.

  • hypertension
  • epidemiology
  • commitment of health care

Data availability statement

Data are available upon reasonable request. Technical appendix, statistical code and dataset are available upon asking from the corresponding author.

https://creativecommons.org/licenses/by/4.0/

This is an open up access commodity distributed in accordance with the Artistic Commons Attribution iv.0 Unported (CC Past 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original piece of work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/iv.0/.

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  • hypertension
  • epidemiology
  • delivery of health care

Cardinal questions

What is already known most this subject?

  • Hypertension is a hemodynamic-related disorder characterized by abnormalities of the cardiac output, systemic vascular resistance, or a combination of both. Measurement of the various hemodynamic parameters using impedance cardiography (ICG) in stable patients with hypertension provides information that may enable more effective targeted drug management.

What does this study add?

  • This written report shows an ICG-guided handling strategy could atomic number 82 to greater reductions in blood pressure levels than were observed with standard care in a existent-globe population of outpatients with hypertension.

How might this impact on clinical practice?

  • Equally clinical care is moving towards precision medicine, our findings identify the needs of more than refined hemodynamic measurement to facilitate personalized treatment in patients with hypertension.

Background

Hypertension is a haemodynamic-related disorder characterised by abnormalities of the cardiac output (CO), systemic vascular resistance (SVR) or a combination of both.1 Despite that hypertension is routinely diagnosed and managed based on degree of blood pressure (BP) height solitary, patients with like caste of BP peak can take different underlying haemodynamic profiles.two 3 These variations in haemodynamic profiles may have important implications for treatment selection considering the choice for patients with a higher CO might be different than for those with a higher SVR. Selecting treatment strategies based on haemodynamic profiles for patients with hypertension may improve BP control.

Impedance cardiography (ICG) is a safe and accurate non-invasive tool to measure haemodynamic parameters4 five that can be performed in the outpatient setting.6 vii Measurement of the various haemodynamic components using ICG in stable patients with hypertension provides data that may enable more than constructive targeted drug management. Although several previous studies have used ICG to evaluate haemodynamic parameters and demonstrated that ICG-guided therapy improves BP control,seven–9 they used a traditional randomised controlled trial blueprint, in which the operationalisation of the intervention had stricter instructions and patients were more than frequently monitored than routine clinical care. Whether an ICG-guided strategy for hypertension treatment tin can lead to improvements in BP control in real-earth clinical settings has been rarely tested. Additionally, previous studies were all conducted in the USA8 ix; no study has focused on low-income and middle-income counties where healthcare resources are limited, patient characteristics and clinical practice patterns are different.

Accordingly, we conducted a businesslike randomised trial to produce preliminary information virtually the effectiveness of ICG-guided strategies for patients with hypertension in routine clinical intendance in China. We hypothesised that selecting antihypertensive therapy based on each patient's haemodynamic profile measured by ICG could lead to more than effective BP reduction and hypertension control than standard care in hypertensive patients in a real-world setting.

Methods

Eligibility

The report population was patients who sought outpatient intendance for hypertension in the hypertension clinic of the Cardiology Department at the Peking University People's Hospital between June and December 2019 in Beijing, China. Patients were eligible if they were 18–85 years old, were local residents, had a diagnosis of essential hypertension and were currently on less than four antihypertensive medications of different classes with systolic BP (SBP) of ≥140 mm Hg or diastolic BP (DBP) of ≥90 mm Hg. If patients were on a combination antihypertensive drug, they would be considered on multiple classes of antihypertensive drugs. Patients were excluded if they were already on iv or more antihypertensive agents of different classes (considered equally resistant hypertension); had on-site SBP of <140 mm Hg and DBP of <90 mm Hg; had secondary hypertension, severe renal disease, cancer, astringent valvular disease, cerebrovascular event within 6 months, atrial fibrillation; or had uncontrolled diabetes with fasting blood glucose of xi.1 mmol/Fifty.

Randomisation and process

After informed consent, patients meeting inclusion/exclusion criteria were randomised in a i:1 ratio to the haemodynamic group or the standard intendance group. Unproblematic randomisation was performed using a random number generator with concealed resource allotment. Randomisation was performed at the patient rather than the provider level, as outpatients at the participating clinic may be cared for by different providers throughout the study. All study investigators were blinded to patient randomisation status until enrolment was complete.

Patients' data including historic period, sex, weight, height, BP and antihypertensive medications was nerveless by nurses during the outpatient visit. Weight was measured to the nearest 0.1 kg with patients wearing lite indoor clothing and no shoes. Height was measured to the nearest 0.1 cm, using a portable stadiometer (Omron HNJ-318; Omron Corporation, Kyoto, Japan) with patients continuing without shoes and heels against the wall. BP was measured on the right upper arm after v min of rest in a seated position using an electronic BP monitor (Omron HBP-9020; Omron Corporation). ICG data were collected by trained technicians at each visit in all patients, but ICG findings were not revealed in the standard arm to physicians or patients. ICG was performed with patients in the supine position, resting for 3 min before measurement. By applying a constant, low amplitude, high-frequency, alternate electric current to the thorax, ICG device measures the corresponding voltage to notice beat-to-vanquish changes in thoracic electric resistance, known as impedance and with it stroke volume is estimated.10 11 So, using middle charge per unit, mean arterial BP and BMI, other haemodynamic parameters are calculated, including CO, cardiac index (CI), SVR, SVR index (SVRI), arterial stiffness index (AS) and a volume parameter—thoracic blood saturation ratio (TBR).12 The ICG device used (CHM P2505, designed by Beijing Li-Heng Medical Technologies, manufactured by Shandong Baolihao Medical Appliances) was developed based on improved hardware and avant-garde digital filtering algorithms,13 and has been validated versus both invasive thermodilution and non-invasive echocardiography in different settings.fourteen–16

Intervention

Later on randomisation, therapy was initiated in all patients. Physicians in both groups were encouraged to prescribe medications consistent with the 2018 Chinese hypertension guideline,17 their clinical sentence, and patient clinical characteristics. In the haemodynamic group, physicians were provided with patients' ICG findings and a computerised clinical decision support of recommended handling choices based on patients' haemodynamic profiles. Specifically, the clinical conclusion support system adamant the haemodynamic phenotype of a patient in three steps: commencement, the computer organization calculated the population mean and SD of each haemodynamic parameter (eg, 60 minutes, CI, AS, SVRI, TBR) given patient'due south gender, historic period, weight, height and BMI, using information from a large sample of 114 198 generally good for you Chinese adults (see detailed description in online supplemental file i).2 3 Because haemodynamic parameters vary by historic period, gender, height and weight, nosotros used personalised cutoffs equally opposed to one-size-fits-all cutoffs to define haemodynamic phenotypes. 2nd, the reckoner system determined if the patient had an elevated haemodynamic parameter based on whether the patient's value was greater than the population mean plus one SD of the respective parameter. Finally, the clinical decision support categorised patients into 4 clinically relevant haemodynamic phenotypes, including cardiac phenotype (high HR or high CI), arterial vascular phenotype (high Equally), peripheral vascular phenotype (high SVRI) and volemic phenotype (high TBR).eighteen 19 These four haemodynamic phenotypes included cardiac phenotype (loftier HR or high CI), arterial vascular phenotype (high Equally), peripheral vascular phenotype (high SVRI) and volemic phenotype (high TBR). Suggested treatment strategies were then provided for each phenotype (encounter details in effigy 1). Physicians were instructed to apply this information to guide decisions about pharmacological agents and dosing. Physicians could share ICG information with patients in the haemodynamic arm. In the standard care group, physicians were non provided with patients' ICG findings and were instructed to use their own clinical judgement to make handling decisions. To minimise the potential misreckoning due to lifestyle modification, physicians in both groups were instructed non to prescribe non-pharmacological interventions as function of their treatment plans. All patients in both groups received didactics on the importance of medication compliance.

Supplemental textile

Figure 1

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Figure ane

Suggested handling strategy for the haemodynamic group. CCB, calcium channel blockers; RASI, renin-angiotensin system inhibitors. In case of evaluation of multiple indicators, first consider the highest one, or considering drug combinations. In example that the recommended drug is already used, consider dose titration, switching to extended release formulation or switching to a different in the aforementioned drug class. Based on hemodynamic phenotyping, terminal drug choices should take in consideration comorbidity and other clinical info. ↑ : Value greater than "baseline + 1SD", baseline and SD based on big sample Chinese full general population, adjusted for individual factors such as: age, sex, pinnacle and weight. 60 minutes ↑ *: HR>75 b/min; Simply in case of depression cardiac output (CI<baseline-2SD), utilise beta-blockers charily. Equally, aortic/arterial stiffness; CI, cardiac alphabetize; SVRI, systemic vascular resistance index; TBR, thoracic blood standing/supine ratio.

Outcome measures

All patients were required to return to the clinic for a follow-up visit between 4 and 12 weeks after the baseline visit. During the follow-up visit, BP was measured on the right upper arm after v min of residue in a seated position using an electronic BP monitor (Omron HBP-9020). The technicians who measured BP were blinded to the intervention arm. The primary written report end points were changes in SBP and DBP from baseline. Secondary study end points included (one) accomplishment of BP goal of <140/xc mm Hg and (2) changes in SBP and DBP by baseline BP, historic period, sex and BMI.

Statistical analysis

We described continuous variables as mean±SD and categorical variables as n (%). Differences in continuous variables between treatment groups were examined by the Educatee's t-examination and in categorial variables using Fisher's exact tests. Subgroup analysis was performed by baseline BP, age, sex activity, BMI and haemodynamic phenotype. We used Breslow-Twenty-four hour period test to exam the consistency of different stratified OR across subgroups and used Forest plots for visualisation. Nosotros performed additional evaluation of changes in haemodynamic parameters between baseline and follow-up visit past pair-sample t-test. Statistical significance was defined every bit a two-tailed p<0.05. All statistical analyses were conducted using R, Five.3.four.1 (The R Foundation for Statistical Computing, Vienna, Austria). The study followed the guidelines for randomised trial, described in the Consolidated Standards of Reporting Trials statement.20

Patient interest

No patients were involved in the development of the enquiry question or the outcome measures, or in developing plans for the design and implementation of the written report. The data are deidentified and, therefore, cannot be shared with the report participants directly.

Results

Characteristics of study population

Between 1 June and 31 December 2019, we screened 201 patients presenting to the hypertension clinic for outpatient intendance, from which we excluded 87 individuals whose baseline BP value is less than 140/90 mm Hg, leaving 114 patients randomised to the intervention and control arms. We farther excluded 12 patients who did not make follow-up visits within 4–12 weeks. Finally, a total of 102 patients (51 in the standard care group and 51 in the haemodynamic group) completed the written report and were analysed (online supplemental figure 1). Among 102 patients, the mean age of 54±14 years and 41% were female. Patients had a hateful SBP of 150.ix (±11.5) mm Hg, mean DBP of 91.1 (±11.iii) mm Hg, mean CI of 3.i (±0.seven) L/min/yard2, mean SVRI of 3017 (±731) dynes s/cm5/grand2, mean heart rate of 72 (±10.half dozen) beats/min (table i).

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Table 1

Characteristics of study participants at baseline

In the haemodynamic group, 13 patients had cardiac phenotype (loftier HR or high CI), xi had arterial vascular phenotype (high AS), 30 had peripheral vascular phenotype (high SVRI) and 17 volemic phenotype (loftier TBR), respectively. In the control group, 13 patients had cardiac phenotype, 18 had arterial vascular phenotype, 26 had peripheral vascular phenotype and 11 volemic phenotype, respectively. There were no statistically pregnant differences in the number and course of antihypertensive medications, patient demographic, clinical, BP or ICG variables at baseline betwixt the haemodynamic group and the command group (table ane and online supplemental tables 1–3). Baseline ICG variables and patient characteristics by haemodynamic phenotype were presented in online supplemental tables 1 and 2.

Effect of the ICG-guided handling strategy on BP control

BP and ICG values at the baseline and follow-up visit as well as their differences between the two visits are shown in online supplemental table 4 and effigy 2. Both SBP and DBP reductions were significantly greater in the haemodynamic grouping from baseline to follow-upwardly visit compared with the standard care grouping (SBP reductions: nineteen.9±10.7 vs 12.0±11.8 mm Hg, p<0.001; DBP reduction: 11.three±6.two vs four.ix±9.9 mm Hg, p<0.001). Terminal BP was lower in the haemodynamic group compared with the standard care grouping (SBP: 131.9±10.9 vs 138.0±thirteen.7 mm Hg, p<0.001; DBP: 81.4±7.7 vs 84.six±12.9 mm Hg, p<0.001). The proportion of patients achieving BP goal of <140/90 mm Hg was also larger in the haemodynamic group compared with the standard intendance grouping (67% vs 41%; p=0.017).

Figure 2

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Figure 2

Blood pressure (BP) reduction and achievement of BP goals in haemodynamic and standard intendance groups. A: Haemodynamic grouping, B: standard care grouping. DBP, diastolic BP; ICG, impedance cardiography; SBP, systolic BP.

Subgroup analyses by patient gender (men vs women), age (≥50 years vs <50 years), BMI (≥24 vs <24 kg/m2) and baseline BP level (baseline SBP ≥160 vs 140–159 mm Hg; baseline DBP ≥90 vs <ninety mm Hg) have consistently shown a greater BP reduction in the haemodynamic group compared with the standard care grouping. The differences between the two groups were statistically significant for all subgroups, except for DBP in men, SBP in the age of <fifty years and DBP in BMI of <24 kg/grand2 where the differences between the two groups were non-significant. The proportion of patients achieving BP goal of <140/90 mm Hg was statistically significantly larger in the haemodynamic group compared with the standard care group for subgroups of men, age of <fifty years, baseline SBP of <160 mm Hg and baseline DBP of ≥90 mm Hg (figure 3).

Figure 3

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Effigy 3

Achievement of BP goals by age, sex, BMI, baseline BP, use of medication at baseline. AS, aortic resistance index; BMI, body mass alphabetize; BP, claret pressure; DBP, diastolic BP; ICG, impedance cardiography; SBP, systolic BP; SVRI, systemic vascular resistance index.

Effigy 4 showed BP reduction between two treatment groups by haemodynamic phenotypes. BP reduction was significantly larger in haemodynamic group compared with the standard care group for patients with hyperdynamic phenotype (high Hr or high CI), arterial hyper-resistive phenotype (high Every bit) and peripheral artery hyper-resistive phenotype (high SVRI). BP reduction was not statistically meaning in patients with high volume phenotype (loftier TBR).

Figure 4

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Effigy iv

BP reduction by patients with different haemodynamic phenotypes. A: Haemodynamic group, B: standard care group. Equally, arterial stiffness alphabetize; BP, blood pressure; DBP, diastolic BP; ICG, impedance cardiography; SBP, systolic BP; SVRI, systemic vascular resistance alphabetize.

Correlation betwixt antihypertensive agents and changes in haemodynamic parameters

In haemodynamic group, CI was statistically significantly reduced from baseline to follow-up visit in patients treated with beta-blockers (p=0.044, effigy five). TBR was statistically significantly reduced in patients treated with thiazide or thiazide-like diuretics (p=0.001). Both AS and SVRI were statistically significantly reduced in patients treated with calcium aqueduct blockers (p=0.003), and SVRI was statistically significantly reduced in patients treated with renin-angiotensin system inhibitors (p<0.001).

Figure 5

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Figure five

Impact of different antihypertensive agents on haemodynamic parameters. AS, arterial stiffness alphabetize; BB, beta-blockers; CB, calcium channel blockers; CI, cardiac index; DD, diuretics; RASI, renin‐angiotensin arrangement inhibitors; TBR, thoracic blood saturation ratio.

Discussion

In a trial of stable hypertensive patients routinely seen in clinical practice in China, we showed that an ICG-guided handling strategy was more constructive in reducing BP than standard therapy. These results were consistent beyond subgroups based on age, sex, BMI, baseline BP and haemodynamic phenotype. Our findings suggest that antihypertensive therapy tailored to each patient's haemodynamic aberration could lead to more effective antihypertensive regimens and lay the groundwork for a more than definitive trial.eight 9 21 22

Of note, the reductions in BP in both groups were large, with an almost 20 mm Hg decrease in SBP in the ICG-guided intervention group. The magnitude of the BP reduction in our study is largely consistent with previous studies conducted in the USA. Smith et al conducted a randomised controlled trial of 164 uncontrolled hypertensive patients on 1–3 medications.8 After 3 months of treatment, patients in the ICG-guided group had an boilerplate SBP reduction of 19 mm Hg compared with 12 mm Hg in the standard care group. Taler et al randomised 104 patients with hypertension uncontrolled on ii or more drugs to a 3-month trial of ICG-guided therapy or standard therapy directed by a hypertension specialist.9 In this written report, the mean BP reduced from 169/87 mm Hg to 139/72 mm Hg in the ICG-guided group versus from 173/91 mm Hg to 147/79 mm Hg in the control group. We further extended previous studies past using a businesslike blueprint to test the ICG-guided intervention in real-life clinical practice and conducting the study in a low-income and middle-income country. We likewise provided a clinical decision back up tool in addition to the ICG study to facilitate the antihypertensive treatment selection, producing a magnitude of BP improvement in routine clinical exercise similar as that in the clinical trials.

There are several potential explanations for the findings in this written report. Commencement, the presumed mechanism for improved BP control with ICG-guided intervention is primarily due to personalised antihypertensive drug choice targeted at the haemodynamic cause of elevated BP. High BP results from one or more haemodynamic abnormality, including elevated CO, SVR and blood volume.23 Dissimilar antihypertensive agents act on different mechanisms to reduce BP by reducing CO or SVR. For example, beta-blockers cake the effects of the hormone epinephrine and make the middle to beat more slowly and with less force, which then reduce CO and lower BP. Angiotensin-converting enzyme inhibitors (ACEIs)/(angiotensin receptor blockers interfere with the torso'due south renin-angiotensin-aldosterone system that leads to increased sodium and urine excreted, reduced resistance in blood vessels and increased venous chapters, which then reduce SVR and lower BP. Our ICG-guided intervention provides data on the underlying cause of elevated BP and uses clinical decision support to guide clinicians in selecting antihypertensive therapies targeted at the haemodynamic abnormality associated with the elevated BP, thereby maximising the BP lowering response for the given therapeutic selection.

Second, the larger reduction in BP in the intervention group may have been, in role, a reflection of comeback in therapeutic inertia. Therapeutic inertia, which refers to the failure of clinicians to initiate or intensify treatments when the BP is not at goal, has been showed equally a almost mutual cause of uncontrolled BP in actively treated patients.24 25 Providing clinician access to ICG findings of patients' haemodynamic profiles and clinical decision support tool for treatment selection may reduce therapeutic inertia in the intervention group.

Finally, the comeback of BP may, at least in office, be associated with improved communications and shared controlling between the physician and the patient. The ICG report has served as a tool for physicians to communicate with and brainwash patients on the underlying haemodynamic abnormalities associated with their high BP and rationale for antihypertensive therapy selection in the intervention group. Previous studies have reported that patient–physician communication is an integral office of clinical practice and patients who understand explanations from their physicians are more than likely to acknowledge health problems, modify behaviour and adhere to medications accordingly.26–28

Our findings have important clinical implications. Current diagnosis and management of hypertension are primary based on degree of BP elevation lone, with little attention paid to the underlying haemodynamic profile. Our report provides evidence for better identification of responders to a particular treatment regimen past profiling patients based on their haemodynamic profile using a elementary, not-invasive exam. As clinical intendance is moving towards precision medicine, our findings identify the needs of more refined haemodynamic measurement to facilitate personalised handling in patients with hypertension. Additionally, the use of ICG-guided handling strategy to achieve greater BP control offers a potential for better short-term use of healthcare resources. This is particularly relevant in depression-income and middle-income counties where resource to improve hypertension control are express and need to be more efficiently used. Given hypertension affects over one billion adults (xxx% of the global adult population) in the world,29 such an arroyo has a large potential do good in improving hypertension control and subsequently reducing a big number of cardiovascular events.

Several limitations should exist considered in the estimation of this study. First, this is a written report with express number of participants and relatively short follow-upwardly. We did not collect long-term follow-up information, which could have been useful to appraise the long-term effect of ICG-guided treatment strategies in improving BP control. 2d, our findings also warrant further study in other populations, as our study was conducted among a mostly urban, working class Chinese population and thus the results may not exist generalisable to other populations. Third, we did non assess medication compliance amongst hypertensive patients, which may affect BP values of patients in the two artillery. Still, nosotros used a pragmatic design to evaluate the effectiveness of interventions and we expect the medication compliance would be analogous to the scenarios in real-life routine clinical practice. Mediation refill rates were similar in the two arms equally all patients fulfilled their prescriptions at the infirmary pharmacy on the same twenty-four hour period of the clinical encounters. Finally, we did non mensurate patients' behaviour change at home and patients may make lifestyle aligning, such as reducing salt intake. Nonetheless, this should exist equally possible in both intervention and control groups given patients blinded in the trial.

In conclusion, a handling strategy guided by haemodynamic measurements reduced BP more effectively than standard care in this trial in China. These findings justify farther large-scale studies to provide more definitive evidence.

Data availability statement

Data are available upon reasonable request. Technical appendix, statistical lawmaking and dataset are bachelor upon request from the corresponding author.

Ethics statements

Patient consent for publication

Ethics approval

The study was reviewed and canonical by the Peking University Institutional Review Board (reference ID: EC20190701). All hypertensive outpatients provided written informed consent and had study procedures consequent with the protocol.

Acknowledgments

We thank all the subjects for their participation.

Supplementary materials

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  • Correction

    Open up Center 2021; 8 - Published Online First: 28 Oct 2021. doi: 10.1136/openhrt-2021-001719corr1

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    British Cardiovascular Society

    Open Eye 2021; 8 - Published Online Commencement: 23 Nov 2021. doi: ten.1136/openhrt-2021-001719corr2