HypertensionCRHCNCT03527719
China Rural Hypertension Control Project
A study testing Village-doctor-led multifaceted intervention in people with Hypertension, run by First Hospital of China Medical University at 1 site in China.
Trial summary
China Rural Hypertension Control (CRHC) Project is a cluster randomized trial that will test the effectiveness of a village doctor-led multifaceted intensive blood pressure intervention on hypertension control in 18 months (Phase 1), cardiovascular disease risk in 36 months (Phase 2), and all-cause dementia in 48… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Village-doctor-led multifaceted intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33,995 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligibility criteria for study villages:
- The village has a regular village doctor who is willing to participate in the hypertension control project
- The village does not plan to merge with other villages within 3 years
- The village is at least 2 kilometers away from other participating villages
- The village participates in the China New Rural Cooperative Medical Scheme
Eligibility criteria of study participants:
- Men or women aged ≥40 years
- Mean untreated systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg or mean treated systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg for individuals without a history of clinical CVD; or mean treated/untreated systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg for individuals with a history of clinical coronary heart disease, heart failure, stroke, diabetes, or chronic kidney disease
- Have lived in a participating village for at least 6 months
- No intention to migrate within next 3 years
- Taking part in the New Rural Cooperative Medical Scheme
- Not pregnant or planning to become pregnant
- No malignant tumors and life expectancy ≥3 years
- Willing to participate and able to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China
China Rural Hypertension Control (CRHC) Project is a cluster randomized trial that will test the effectiveness of a village doctor-led multifaceted intensive blood pressure intervention on hypertension control in 18 months (Phase 1), cardiovascular disease risk in 36 months (Phase 2), and all-cause dementia in 48 months (Phase 3) among patients with hypertension in rural China. An extended observational follow-up, the CRHCP post-intervention observational follow-up study, will be conducted at Year 7 to evaluate long-term effects.
Read the detailed description
The overall objective of the CRHC Project is to develop an effective, adoptable, and sustainable implementation strategy to achieve more intensive blood pressure (BP) control among rural residents in China. Moreover, this effectiveness-implementation trial will test the effectiveness of a lower BP target (<130/80 mmHg) on cardiovascular disease (CVD) and all-cause dementia. Specifically, we will test the effectiveness of a village doctor-led multifaceted intervention, compared with usual care, on BP control, CVD, and dementia among rural residents with hypertension in China. This cluster randomized trial is conducted in 326 villages from three provinces in mainland China. A total of 163 villages was randomly assigned to a village doctor-led multifaceted intervention and 163 villages to usual care, stratified by provinces, counties, and townships. A total of 33,995 individuals aged ≥40 years with uncontrolled hypertension were recruited into the study. The village doctor-led multifaceted intervention is designed to overcome barriers at the healthcare system, provider, patient, and community levels. Study participants are followed every 6 months for BP, CVD, and other study outcomes. The primary outcome is BP control (<130/80 mm Hg) at 18 months in phase 1, CVD events over 36 months in phase 2, and all-cause dementia at 48 months in phase 3. In addition, an extended observational follow-up will be conducted at Year 7 without further active intervention, to evaluate long-term outcomes including major cardiovascular events, dementia or cognitive outcomes, all-cause mortality, renal outcomes, and the sustainability of implementation fidelity.
- Conditions
- Hypertension
- Being tested
- Village-doctor-led multifaceted intervention
- Keywords
- Hypertension, Cardiovascular disease, Dementia, China, Protocol-based treatment, Stroke
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Village-doctor-led multifaceted interventionOther
- Establishing a network including hypertension specialists at city/county hospitals, primary care physicians at township hospitals, and village doctors to collaboratively manage hypertension
- Using hypertension control rate as one of the metrics for incentive supplements to village doctors
- Providing discounted or free antihypertensive medications to patients with hypertension
- Training village doctors to measure blood pressure according to a standard protocol
- Training village doctors to use a simple stepwise protocol for hypertension treatment
- Training village doctors to conduct health coaching on lifestyle change (e.g., lowering sodium and alcohol intake) and medication adherence
- Providing free blood-pressure monitor and training to patients for home blood pressure measurement
- Encouraging lifestyle change and medication adherence
- Connecting patients through WeChat or telephone for group social support
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Village-doctor-led multifaceted intervention Receives: Other: Village-doctor-led multifaceted intervention |
| Control Group | No intervention | Village doctors in usual care group will not receive hypertension management training or support. However, they will be trained in standardized BP measurement. Participants in control group will receive their usual care from village doctors or primary care physicians in township hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome of Phase 1: Hypertension control rate
The proportion of participants with controlled blood pressure（< 130/80 mm Hg）
Measured: 18 months after baseline
Primary Outcome of Phase 2: Composite cardiovascular disease outcome
Record the occurrence of newly diagnosed composite cardiovascular disease
Measured: 36 months after baseline
Primary Outcome of Phase 3: All-cause dementia
Record all-cause dementia
Measured: 48 months after baseline
Primary Outcome of Extension Study: Composite cardiovascular disease outcome
Record the occurrence of newly diagnosed composite cardiovascular disease
Measured: Year 7 after baseline
Secondary outcomes (27)
Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes
Mean systolic and diastolic pressure changes of participants
Measured: 18 months after baseline
Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm)
The proportion of participants with controlled blood pressure（< 140/90 mm Hg）
Measured: 18 months after baseline
Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate
Use questionnaires to assess the proportion of participants who adhere to antihypertensive drugs
Measured: 18 months after baseline
Secondary Outcome of Phase 2: Stroke
Number of newly diagnosed stroke
Measured: 36 months after baseline
Secondary Outcome of Phase 2: Myocardial infarction
Number of newly diagnosed myocardial infarction
Measured: 36 months after baseline
Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment
Number of patients with newly diagnosed heart failure requiring hospitalization or treatment
Measured: 36 months after baseline
Secondary Outcome of Phase 2: Cardiovascular disease death
Number of cardiovascular disease death
Measured: 36 months after baseline
Secondary Outcome of Phase 2: All-cause death
Number of all-cause death
Measured: 36 months after baseline
Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes
Mean systolic and diastolic pressure changes of participants
Measured: 36 months after baseline
Secondary Outcome of Phase 3: Cognitive impairment no dementia
Record cognitive impairment no dementia
Measured: 48 months after baseline
Secondary Outcome of Phase 3: Composite outcome of dementia and cognitive impairment no dementia
Record the composite outcome of dementia and cognitive impairment no dementia
Measured: 48 months after baseline
Secondary Outcome of Phase 3: Death from all causes
Record death from all causes
Measured: 48 months after baseline
Secondary Outcome of Phase 3: Composite outcome of dementia or deaths
Record the composite outcome of dementia or deaths
Measured: 48 months after baseline
Secondary Outcome of Phase 3: Composite and individual cardiovascular disease (myocardial infarction, stroke, heart failure requiring hospitalization or treatment, and cardiovascular death)
Record the composite and individual cardiovascular disease (myocardial infarction, stroke, heart failure requiring hospitalization or treatment, and cardiovascular death)
Measured: 48 months after baseline
Secondary Outcome of Phase 3: Changes in mean systolic and diastolic blood pressure from baseline to 48 months
Record changes in mean systolic and diastolic blood pressure from baseline to 48 months
Measured: 48 months after baseline
Secondary Outcome of Phase 3: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months
Record the proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months
Measured: 48 months after baseline
Secondary Outcome of Extension Study: Composite outcome of dementia and cognitive impairment no dementia
Record the composite outcome of dementia and cognitive impairment no dementia
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: Stroke
Number of newly diagnosed stroke
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: Myocardial infarction
Number of newly diagnosed myocardial infarction
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: Heart failure requiring hospitalization or treatment
Number of patients with newly diagnosed heart failure requiring hospitalization or treatment
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: Cardiovascular disease death
Number of cardiovascular disease death
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: All-cause death
Number of all-cause death
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: All-cause dementia
Record all-cause dementia
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: Cognitive impairment no dementia
Record cognitive impairment no dementia
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: Mean systolic and diastolic pressure changes
Record changes in mean systolic and diastolic blood pressure
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg)
Record the proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg)
Measured: Year 7 after baseline
Secondary Outcome of Extension Study: Adherence to antihypertensive medication rate
Use questionnaires to assess the proportion of participants who adhere to antihypertensive drugs
Measured: Year 7 after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start8 May 2018
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33,995 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University, First Affiliated Hospital Xi'an Jiaotong University, Tongji Hospital, Disease Control and Prevention Centre of Liaoning Province, Chaoyang Central Hospital, Hanzhong People's Hospital, Disease Control and Prevention Centre of Chaoyang City, Shengjing Hospital
- Responsible party
- Principal investigator, Yingxian Sun, First Hospital of China Medical University
- Investigators
- Yingxian Sun, MD, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527719
- Sponsor's protocol ID
- KLS20181582
- Acronym
- CRHC
- Status last verified
- Aug 2025
- First submitted
- 22 Apr 2018
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun G, Guo X, Zhao C, Ouyang N, Li G, Wang C, Ren Y, Xing L, Sun Z, Qiao L, Zhong S, Liu S, Yin Y, Yu Y, Tan X, Zhang C, He C, Jiang X, Chen Y, Wang D, Sun Y; CRHCP Study Group. Long-Term Effectiveness of Intensive Blood Pressure Management Led by Nonphysician Community Healthcare Providers on Cardiovascular Events: 7-Year Follow-Up of a Cluster Randomized Trial. Circulation. 2026 Aug 28. doi: 10.1161/CIRCULATIONAHA.126.082511. Online ahead of print.
PubMed 42666029Guo X, Sun G, Xie Z, Zhou S, Ye N, Yang C, Miao W, Yin Y, Xing L, Yu Y, Li Z, Tan X, Zhang C, He C, Liu Y, Chen Y, Zhou X, Jiang Y, Lu M, Sun Y. Cardiovascular Health Change Patterns After Multifaceted Antihypertensive Intervention and Cardiovascular Outcomes: A Post Hoc Analysis of CRHCP Trial. J Am Coll Cardiol. 2026 Jun 26:S0735-1097(26)06702-1. doi: 10.1016/j.jacc.2026.05.035. Online ahead of print.
PubMed 42417693Liu S, Yin Y, Yang H, Sun L, Wang J, Zhou Y, Guan L, Xing L, Xie Z, Ye N, Yang C, Miao W, Zhou S, Yu Y, Li Z, Tan X, Zhang C, He C, Liu Y, Chen Y, Sun G, Guo X. Cardiovascular outcomes of intensive blood pressure control in patients with and without metabolic dysfunction-associated fatty liver disease: post hoc analysis of the CRHCP trial. BMC Med. 2026 Mar 4;24(1):222. doi: 10.1186/s12916-026-04678-2.
PubMed 41776553Guo X, Zhou S, Mu J, Zhao C, Sun G, Zhou Y, Yu Y, Tan X, Yin Y, Xie Z, Miao W, Li W, Zhang C, He C, Chen J, Tian X, Li T, Chen Y, Zhou X, Lu M, Li Q, Ye N, Li G, Sun Y. Intensive Blood Pressure Control and Cardiovascular Outcomes Across Cardiovascular-Kidney-Metabolic Syndrome Stages: A Post Hoc Analysis of the China Rural Hypertension Control Project. JAMA Netw Open. 2026 Feb 2;9(2):e2557180. doi: 10.1001/jamanetworkopen.2025.57180.
PubMed 41686438Sun G, Ye N, Wang C, Liu S, Miao W, Qiao L, Ouyang N, Geng D, Shi C, Zhang L, Zhang P, Yin Y, Xie Z, Yu Y, Sun Y. Evaluating intensive blood pressure control versus usual care on cardiovascular disease in patients with diabetes using win statistics: a subgroup analysis of a cluster randomized trial. J Adv Res. 2026 Jun;84:965-974. doi: 10.1016/j.jare.2025.09.054. Epub 2025 Sep 29.
PubMed 41033581Lu X, Wang J, Chen S, Lv L, Yu J. Effect of Comprehensive Health Management on Medication Adherence and Healthy Lifestyle Behavior of Patients With Hypertension. Int J Hypertens. 2025 Jul 19;2025:1165809. doi: 10.1155/ijhy/1165809. eCollection 2025.
PubMed 41018530Sun G, Miao W, Liu S, Yin Y, Geng D, Ye N, Xie Z, Zhang L, Zhou S, Wang C, Qiao L, Pei S, Ouyang N, Shi C, Guo X, Sun Y. Intensive Systolic Blood Pressure Reduction and Kidney and Cardiovascular Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519604. doi: 10.1001/jamanetworkopen.2025.19604.
PubMed 40643915He J, Zhao C, Zhong S, Ouyang N, Sun G, Qiao L, Yang R, Zhao C, Liu H, Teng W, Liu X, Wang C, Liu S, Chen CS, Williamson JD, Sun Y. Blood pressure reduction and all-cause dementia in people with uncontrolled hypertension: an open-label, blinded-endpoint, cluster-randomized trial. Nat Med. 2025 Jun;31(6):2054-2061. doi: 10.1038/s41591-025-03616-8. Epub 2025 Apr 21.
PubMed 40258956Sun G, Guo X, Li G, Zhang P, Yin Y, Qiao L, Ye N, Wang C, Liu S, Geng D, Miao W, Xie Z, Yu Y, Li Z, Jiang X, Tan X, Sun Y. Intensive Blood Pressure Strategy on Cardiovascular Diseases in Patients With Metabolic Syndrome: Post Hoc Analysis of a Clinical Trial. J Am Heart Assoc. 2025 Mar 18;14(6):e036820. doi: 10.1161/JAHA.124.036820. Epub 2025 Mar 13.
PubMed 40079319Sun G, Wang C, Ye N, Shi C, Ouyang N, Qiao L, Li G, Zhang L, Yu Y, Li Z, Zhou Y, Chen Z, Zhang S, Zhang P, Geng D, Miao W, Liu S, Sun Y. Impact of baseline cardiovascular risk on the outcomes of intensive blood pressure intervention: a post hoc analysis of the China rural hypertension control project. BMC Med. 2024 Jun 20;22(1):258. doi: 10.1186/s12916-024-03494-w.
PubMed 38902731Guo X, Ouyang N, Sun G, Zhang N, Li Z, Zhang X, Li G, Wang C, Qiao L, Zhou Y, Chen Z, Shi C, Liu S, Miao W, Geng D, Zhang P, Sun Y; CRHCP Study Group. Multifaceted Intensive Blood Pressure Control Model in Older and Younger Individuals With Hypertension: A Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):781-790. doi: 10.1001/jamacardio.2024.1449.
PubMed 38888905He J, Ouyang N, Guo X, Sun G, Li Z, Mu J, Wang DW, Qiao L, Xing L, Ren G, Zhao C, Yang R, Yuan Z, Wang C, Shi C, Liu S, Miao W, Li G, Chen CS, Sun Y; CRHCP Study Group. Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention versus usual care on cardiovascular disease (CRHCP): an open-label, blinded-endpoint, cluster-randomised trial. Lancet. 2023 Mar 18;401(10380):928-938. doi: 10.1016/S0140-6736(22)02603-4. Epub 2023 Mar 2.
PubMed 36871573Sun Y, Mu J, Wang DW, Ouyang N, Xing L, Guo X, Zhao C, Ren G, Ye N, Zhou Y, Wang J, Li Z, Sun G, Yang R, Chen CS, He J; CRHCP Study Group. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial. Lancet. 2022 May 21;399(10339):1964-1975. doi: 10.1016/S0140-6736(22)00325-7. Epub 2022 Apr 29.
PubMed 35500594Sun Y, Li Z, Guo X, Zhou Y, Ouyang N, Xing L, Sun G, Mu J, Wang D, Zhao C, Wang J, Ye N, Zheng L, Chen S, Chang Y, Yang R, He J. Rationale and Design of a Cluster Randomized Trial of a Village Doctor-Led Intervention on Hypertension Control in China. Am J Hypertens. 2021 Aug 9;34(8):831-839. doi: 10.1093/ajh/hpab038.
PubMed 33605981
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China
- ClinicalTrials.gov ID
- NCT03527719
- Acronym / sponsor ID
- CRHC / KLS20181582
- Conditions
- Hypertension
- Keywords
- Hypertension, Cardiovascular disease, Dementia, China, Protocol-based treatment, Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33,995 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- Tulane University, First Affiliated Hospital Xi'an Jiaotong University, Tongji Hospital, Disease Control and Prevention Centre of Liaoning Province, Chaoyang Central Hospital, Hanzhong People's Hospital, Disease Control and Prevention Centre of Chaoyang City, Shengjing Hospital
- Study start
- 8 May 2018 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 May 2018 (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.
China Rural Hypertension Control (CRHC) Project is a cluster randomized trial that will test the effectiveness of a village doctor-led multifaceted intensive blood pressure intervention on hypertension control in 18 months (Phase 1), cardiovascular disease risk in 36 months (Phase 2), and all-cause dementia in 48 months (Phase 3) among patients with hypertension in rural China. An extended observational follow-up, the CRHCP post-intervention observational follow-up study, will be conducted at Year 7 to evaluate long-term effects.
Detailed description
The overall objective of the CRHC Project is to develop an effective, adoptable, and sustainable implementation strategy to achieve more intensive blood pressure (BP) control among rural residents in China. Moreover, this effectiveness-implementation trial will test the effectiveness of a lower BP target (<130/80 mmHg) on cardiovascular disease (CVD) and all-cause dementia. Specifically, we will test the effectiveness of a village doctor-led multifaceted intervention, compared with usual care, on BP control, CVD, and dementia among rural residents with hypertension in China. This cluster randomized trial is conducted in 326 villages from three provinces in mainland China. A total of 163 villages was randomly assigned to a village doctor-led multifaceted intervention and 163 villages to usual care, stratified by provinces, counties, and townships. A total of 33,995 individuals aged ≥40 years with uncontrolled hypertension were recruited into the study. The village doctor-led multifaceted intervention is designed to overcome barriers at the healthcare system, provider, patient, and community levels. Study participants are followed every 6 months for BP, CVD, and other study outcomes. The primary outcome is BP control (<130/80 mm Hg) at 18 months in phase 1, CVD events over 36 months in phase 2, and all-cause dementia at 48 months in phase 3. In addition, an extended observational follow-up will be conducted at Year 7 without further active intervention, to evaluate long-term outcomes including major cardiovascular events, dementia or cognitive outcomes, all-cause mortality, renal outcomes, and the sustainability of implementation fidelity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Village-doctor-led multifaceted interventionVillage-doctor-led multifaceted intervention |
| Control Group | No intervention | –Village doctors in usual care group will not receive hypertension management training or support. However, they will be trained in standardized BP measurement. Participants in control group will receive their usual care from village doctors or primary care physicians in township hospitals |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Village-doctor-led multifaceted intervention* Establishing a network including hypertension specialists at city/county hospitals, primary care physicians at township hospitals, and village doctors to collaboratively manage hypertension * Using hypertension control rate as one of the metrics for incentive supplements to village doctors * Providing discounted or free antihypertensive medications to patients with hypertension * Training village doctors to measure blood pressure according to a standard protocol * Training village doctors to use a simple stepwise protocol for hypertension treatment * Training village doctors to conduct health coaching on lifestyle change (e.g., lowering sodium and alcohol intake) and medication adherence * Providing free blood-pressure monitor and training to patients for home blood pressure measurement * Encouraging lifestyle change and medication adherence * Connecting patients through WeChat or telephone for group social support | Other | Experimental Group |
Primary outcome
Primary Outcome of Phase 1: Hypertension control rate
Time frame: 18 months after baseline
The proportion of participants with controlled blood pressure（< 130/80 mm Hg）
Primary Outcome of Phase 2: Composite cardiovascular disease outcome
Time frame: 36 months after baseline
Record the occurrence of newly diagnosed composite cardiovascular disease
Primary Outcome of Phase 3: All-cause dementia
Time frame: 48 months after baseline
Record all-cause dementia
Primary Outcome of Extension Study: Composite cardiovascular disease outcome
Time frame: Year 7 after baseline
Record the occurrence of newly diagnosed composite cardiovascular disease
27 secondary outcomes
Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes
Time frame: 18 months after baseline
Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm)
Time frame: 18 months after baseline
Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate
Time frame: 18 months after baseline
Secondary Outcome of Phase 2: Stroke
Time frame: 36 months after baseline
Secondary Outcome of Phase 2: Myocardial infarction
Time frame: 36 months after baseline
Secondary Outcome of Phase 2: Heart failure requiring hospitalization or treatment
Time frame: 36 months after baseline
Secondary Outcome of Phase 2: Cardiovascular disease death
Time frame: 36 months after baseline
Secondary Outcome of Phase 2: All-cause death
Time frame: 36 months after baseline
Secondary Outcome of Phase 2: Mean systolic and diastolic pressure changes
Time frame: 36 months after baseline
Secondary Outcome of Phase 3: Cognitive impairment no dementia
Time frame: 48 months after baseline
Secondary Outcome of Phase 3: Composite outcome of dementia and cognitive impairment no dementia
Time frame: 48 months after baseline
Secondary Outcome of Phase 3: Death from all causes
Time frame: 48 months after baseline
Secondary Outcome of Phase 3: Composite outcome of dementia or deaths
Time frame: 48 months after baseline
Secondary Outcome of Phase 3: Composite and individual cardiovascular disease (myocardial infarction, stroke, heart failure requiring hospitalization or treatment, and cardiovascular death)
Time frame: 48 months after baseline
Secondary Outcome of Phase 3: Changes in mean systolic and diastolic blood pressure from baseline to 48 months
Time frame: 48 months after baseline
Secondary Outcome of Phase 3: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg) at 48 months
Time frame: 48 months after baseline
Secondary Outcome of Extension Study: Composite outcome of dementia and cognitive impairment no dementia
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: Stroke
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: Myocardial infarction
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: Heart failure requiring hospitalization or treatment
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: Cardiovascular disease death
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: All-cause death
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: All-cause dementia
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: Cognitive impairment no dementia
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: Mean systolic and diastolic pressure changes
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: Proportion of hypertension control (BP <130/80 mm Hg or <140/90 mmHg)
Time frame: Year 7 after baseline
Secondary Outcome of Extension Study: Adherence to antihypertensive medication rate
Time frame: Year 7 after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 42666029Sun G, Guo X, Zhao C, Ouyang N, Li G, Wang C, Ren Y, Xing L, Sun Z, Qiao L, Zhong S, Liu S, Yin Y, Yu Y, Tan X, Zhang C, He C, Jiang X, Chen Y, Wang D, Sun Y; CRHCP Study Group. Long-Term Effectiveness of Intensive Blood Pressure Management Led by Nonphysician Community Healthcare Providers on Cardiovascular Events: 7-Year Follow-Up of a Cluster Randomized Trial. Circulation. 2026 Aug 28. doi: 10.1161/CIRCULATIONAHA.126.082511. Online ahead of print.
- Derived from this study: PubMed 42417693Guo X, Sun G, Xie Z, Zhou S, Ye N, Yang C, Miao W, Yin Y, Xing L, Yu Y, Li Z, Tan X, Zhang C, He C, Liu Y, Chen Y, Zhou X, Jiang Y, Lu M, Sun Y. Cardiovascular Health Change Patterns After Multifaceted Antihypertensive Intervention and Cardiovascular Outcomes: A Post Hoc Analysis of CRHCP Trial. J Am Coll Cardiol. 2026 Jun 26:S0735-1097(26)06702-1. doi: 10.1016/j.jacc.2026.05.035. Online ahead of print.
- Derived from this study: PubMed 41776553Liu S, Yin Y, Yang H, Sun L, Wang J, Zhou Y, Guan L, Xing L, Xie Z, Ye N, Yang C, Miao W, Zhou S, Yu Y, Li Z, Tan X, Zhang C, He C, Liu Y, Chen Y, Sun G, Guo X. Cardiovascular outcomes of intensive blood pressure control in patients with and without metabolic dysfunction-associated fatty liver disease: post hoc analysis of the CRHCP trial. BMC Med. 2026 Mar 4;24(1):222. doi: 10.1186/s12916-026-04678-2.
- Derived from this study: PubMed 41686438Guo X, Zhou S, Mu J, Zhao C, Sun G, Zhou Y, Yu Y, Tan X, Yin Y, Xie Z, Miao W, Li W, Zhang C, He C, Chen J, Tian X, Li T, Chen Y, Zhou X, Lu M, Li Q, Ye N, Li G, Sun Y. Intensive Blood Pressure Control and Cardiovascular Outcomes Across Cardiovascular-Kidney-Metabolic Syndrome Stages: A Post Hoc Analysis of the China Rural Hypertension Control Project. JAMA Netw Open. 2026 Feb 2;9(2):e2557180. doi: 10.1001/jamanetworkopen.2025.57180.
- Derived from this study: PubMed 41033581Sun G, Ye N, Wang C, Liu S, Miao W, Qiao L, Ouyang N, Geng D, Shi C, Zhang L, Zhang P, Yin Y, Xie Z, Yu Y, Sun Y. Evaluating intensive blood pressure control versus usual care on cardiovascular disease in patients with diabetes using win statistics: a subgroup analysis of a cluster randomized trial. J Adv Res. 2026 Jun;84:965-974. doi: 10.1016/j.jare.2025.09.054. Epub 2025 Sep 29.
- Derived from this study: PubMed 41018530Lu X, Wang J, Chen S, Lv L, Yu J. Effect of Comprehensive Health Management on Medication Adherence and Healthy Lifestyle Behavior of Patients With Hypertension. Int J Hypertens. 2025 Jul 19;2025:1165809. doi: 10.1155/ijhy/1165809. eCollection 2025.
- Derived from this study: PubMed 40643915Sun G, Miao W, Liu S, Yin Y, Geng D, Ye N, Xie Z, Zhang L, Zhou S, Wang C, Qiao L, Pei S, Ouyang N, Shi C, Guo X, Sun Y. Intensive Systolic Blood Pressure Reduction and Kidney and Cardiovascular Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519604. doi: 10.1001/jamanetworkopen.2025.19604.
- Derived from this study: PubMed 40258956He J, Zhao C, Zhong S, Ouyang N, Sun G, Qiao L, Yang R, Zhao C, Liu H, Teng W, Liu X, Wang C, Liu S, Chen CS, Williamson JD, Sun Y. Blood pressure reduction and all-cause dementia in people with uncontrolled hypertension: an open-label, blinded-endpoint, cluster-randomized trial. Nat Med. 2025 Jun;31(6):2054-2061. doi: 10.1038/s41591-025-03616-8. Epub 2025 Apr 21.
- Derived from this study: PubMed 40079319Sun G, Guo X, Li G, Zhang P, Yin Y, Qiao L, Ye N, Wang C, Liu S, Geng D, Miao W, Xie Z, Yu Y, Li Z, Jiang X, Tan X, Sun Y. Intensive Blood Pressure Strategy on Cardiovascular Diseases in Patients With Metabolic Syndrome: Post Hoc Analysis of a Clinical Trial. J Am Heart Assoc. 2025 Mar 18;14(6):e036820. doi: 10.1161/JAHA.124.036820. Epub 2025 Mar 13.
- Derived from this study: PubMed 38902731Sun G, Wang C, Ye N, Shi C, Ouyang N, Qiao L, Li G, Zhang L, Yu Y, Li Z, Zhou Y, Chen Z, Zhang S, Zhang P, Geng D, Miao W, Liu S, Sun Y. Impact of baseline cardiovascular risk on the outcomes of intensive blood pressure intervention: a post hoc analysis of the China rural hypertension control project. BMC Med. 2024 Jun 20;22(1):258. doi: 10.1186/s12916-024-03494-w.
- Derived from this study: PubMed 38888905Guo X, Ouyang N, Sun G, Zhang N, Li Z, Zhang X, Li G, Wang C, Qiao L, Zhou Y, Chen Z, Shi C, Liu S, Miao W, Geng D, Zhang P, Sun Y; CRHCP Study Group. Multifaceted Intensive Blood Pressure Control Model in Older and Younger Individuals With Hypertension: A Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):781-790. doi: 10.1001/jamacardio.2024.1449.
- Derived from this study: PubMed 36871573He J, Ouyang N, Guo X, Sun G, Li Z, Mu J, Wang DW, Qiao L, Xing L, Ren G, Zhao C, Yang R, Yuan Z, Wang C, Shi C, Liu S, Miao W, Li G, Chen CS, Sun Y; CRHCP Study Group. Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention versus usual care on cardiovascular disease (CRHCP): an open-label, blinded-endpoint, cluster-randomised trial. Lancet. 2023 Mar 18;401(10380):928-938. doi: 10.1016/S0140-6736(22)02603-4. Epub 2023 Mar 2.
- 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.
Yingxian Sun, MD, PhD principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Village-doctor-led multifaceted intervention in people with Hypertension, run by First Hospital of China Medical University 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?
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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary Outcome of Phase 1: Hypertension control rate (time frame: 18 months after baseline). The study lists 4 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 NCT03527719, which also lists 14 linked publications.
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 18 Dec 2025.