AzTrials
AzTrials

HypertensionCHESSNCT05605418

Study of a Comprehensive Intelligent Hypertension managEment SyStem

A study testing CHESS intervention in people with Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This cluster randomized controlled trial aims to evaluate the efficacy of a comprehensive intelligent hypertension management system (CHESS) in blood pressure lowering in primary health care (PHC) settings of China. Read more about this study

Who is it for?
Ages 35 to 79 years
Conditions the study is for
Hypertension
What is being tested?
CHESS intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,666 participants
Where
1 siteChina
Study dates
16 Mar 2023to 30 Oct 2024
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 35 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • An electronic data collection system is routinely used at the clinic for hypertension management in PHC sites, and the distance between sites must be >2km;
  • At least one drug of each of the five classes of recommended antihypertensive medications is available at the clinic:
  • A: Angiotensin-converting enzyme inhibitors (ACEI; e.g., captopril or enalapril);
  • A: Angiotensin receptor blockers (ARB; e.g., losartan or valsartan)
  • B: β-blockers (e.g., atenolol, metoprolol, or bisoprolol)
  • C: Calcium antagonists (e.g., nitrendipine, nifedipine, or amlodipine)
Show all 13Show fewer
  • D: Diuretics (e.g., hydrochlorothiazide, indapamide, or indapamide SR tablets)
  • Has an outpatient clinic for hypertension treatment and staff are willing to take part in the study.
  • Age ≥35 years and <80 years
  • Local resident of the community/township who attends the PHC clinic for hypertension management, and will not travel for more than 3 months during the study period;
  • Established diagnosis of essential hypertension, with uncontrolled BP before randomization (defined as office BP≥140/90mmHg, and 24-hour ambulatory BP≥130/80mmHg);
  • Own and be able to use a smartphone daily;
  • Be willing to participate in the study and sign the informed consent.

Who cannot join

  • Physician-diagnosed or suspected secondary hypertension (e.g. hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug- induced, or rare monogenic genetic disease), or the presence of other structural heart diseases, such as aortic insufficiency, hypertrophic cardiomyopathy, or congenital heart disease;
  • Office or ambulatory SBP≥180 mmHg and/or DBP≥110 mmHg before randomization;
  • Physician-diagnosed atrial fibrillation;
  • Physician-diagnosed CKD, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (if serum creatinine is available), or currently on dialysis treatment;
  • Physician-diagnosed hepatic dysfunction, or ALT≥ 2*ULN;
  • Currently at the unstable or terminal stage of any disease (e.g. new- onset cardiovascular and cerebrovascular diseases occurred within 3 months, malignant tumors);
Show all 12Show fewer
  • Intolerance to at least two classes of antihypertensive medications among A, B, C or D;
  • Currently taking 3 or more antihypertensive drugs;
  • The subject is pregnant or breastfeeding, or planning to become pregnant or breastfeeding during the study period;
  • Have communication or cognitive disorders;
  • Be unwilling to take antihypertensive drugs, or assumed poor adherence to treatment;
  • The subject is participating in other clinical trials at the moment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases

    Beijing

Other trials in China

About this study

Official title: Study of a Comprehensive Intelligent Hypertension managEment SyStem (CHESS) Evaluation in Primary Health Care Settings

This cluster randomized controlled trial aims to evaluate the efficacy of a comprehensive intelligent hypertension management system (CHESS) in blood pressure lowering in primary health care (PHC) settings of China.

Read the detailed description

The trial aims to investigate the efficacy of a comprehensive digital intervention for hypertension treatment in cluster clinics. 40 PHC centers will be selected from different areas in China, and eligible patients being screened consecutively in each site, then all PHC centers will be randomized into intervention group and control group. The physicians and patients from the 20 intervention sites will receive training and support on the use of the CHESS system, and the control group will continue to receive usual care. The multi-faceted CHESS intervention includes: (1) home blood pressure monitoring (HBPM) for patients, and the data will be uploaded to central electronic health records (EHR) automatically; (2) a Smart Reminder and Alert System (SRAS) to send educational messages and reminders to support patients on HBPM, improve blood pressure medication adherence and lifestyle modification; (3) a decision support system (DSS) to provide physicians with antihypertensive medications prescriptions and referral recommendations; (4) regular quality assessment reports will be provided to health care providers automatically to improve the quality of hypertension management at PHC level. All participants will be asked to attend the clinic at least once every 3 months, and be followed up for 12 months.

Conditions
Hypertension
Being tested
CHESS intervention
Keywords
Hypertension, Digital intervention, Ambulatory blood pressure, Home blood pressure monitoring, Cluster randomized controlled trial
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHESS interventionBehavioural

    The multi-faceted CHESS intervention includes: (1) home blood pressure monitoring (HBPM) for patients, and the data will be uploaded to central electronic health records (EHR) automatically; (2) a Smart Reminder and Alert System (SRAS) to send educational messages and reminders to support patients on HBPM, improve blood pressure medication adherence and lifestyle modification; (3) a decision support system (DSS) to provide physicians with antihypertensive medications prescriptions and referral recommendations; (4) regular quality assessment reports will be provided to health care providers automatically to improve the quality of hypertension management at PHC level.

Study groups in NCT05605418
Study groupRoleWhat they receive
CHESS interventionExperimentalPhysicians and patients at the intervention group will receive training and support on the use of the multi-faceted CHESS system.
Receives: Behavioral: CHESS intervention
ControlNo interventionAfter site randomization, physicians at the control sites will manage their patients by usual care at hypertension clinics.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in 24-hour ambulatory SBP from baseline to 12-month follow up;

    The investigators will measure the change in 24-h ambulatory SBP from baseline to 12 months.

    Measured: Baseline; 12 months

Secondary outcomes (8)

  1. Mean changes in 24-hour ambulatory DBP from baseline to 12-month;

    The investigators will measure the change in 24-h ambulatory DBP from baseline to 12 months.

    Measured: Baseline; 12 months

  2. Mean changes in office SBP from baseline to 12-month;

    Patient's office SBP will be measured at hypertension clinics.

    Measured: Baseline; 12 months

  3. Mean changes in office DBP from baseline to 12-month;

    Patient's office DBP will be measured at hypertension clinics.

    Measured: Baseline; 12 months

  4. Proportion of patients with office BP under control at 12-month;

    Office BP under control is defined as blood pressure <130/80 mmHg at hypertension clinic.

    Measured: Baseline; 12 months

  5. Proportion of patients with 24-hour ambulatory BP under control (<130/80 mmHg) at 12-month;

    Ambulatory BP under control is defined as mean ambulatory BP <130/80 mmHg.

    Measured: Baseline; 12 months

  6. Mean changes in 24-hour ABPM heart rate from baseline to 12-month;

    The investigators will measure the change in 24-h ambulatory heart rate from baseline to 12 months.

    Measured: Baseline; 12 months

  7. Proportion of hypertension visits during which inappropriate antihypertensive treatment is prescribed;

    Inappropriate antihypertensive treatment is defined as a prescription incompliant with the pre-specified guideline-based recommendations. Antihypertensive treatment prescriptions will be measured and obtained through questionnaire and medical records information and be compared with decision support system recommendations automatically.

    Measured: Baseline; 12 months

  8. Change in patients' medication adherence of antihypertensive drugs;

    The investigators will measure patients medication adherence using information collected in questionnaire at baseline and 12 month follow up visits.

    Measured: Baseline; 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start16 Mar 2023
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
1,666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605418
Sponsor's protocol ID
2022-GSP-GG-21
Acronym
CHESS
Status last verified
May 2026
First submitted
27 Oct 2022
Last updated
5 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang H, Huo X, Ren L, Lu J, Li J, Zheng X, Liu J, Ma W, Yuan J, Diao X, Wu C, Zhang X, Wang J, Zhao W, Hu S. Design and rationale of the Comprehensive intelligent Hypertension managEment SyStem (CHESS) evaluation study: A cluster randomized controlled trial for hypertension management in primary care. Am Heart J. 2024 Jul;273:90-101. doi: 10.1016/j.ahj.2024.03.018. Epub 2024 Apr 2.

    PubMed 38575049

Questions about this trial

What is this clinical trial studying?

A study testing CHESS intervention in people with Hypertension, run by China National Center for Cardiovascular Diseases 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 13 inclusion and 12 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 5 May 2026. 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?

Mean change in 24-hour ambulatory SBP from baseline to 12-month follow up; (time frame: Baseline; 12 months). 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 NCT05605418, 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 5 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in