China Rural Hypertension Control Project

NCT03527719 | Active Not Recruiting DMC

• 1 other identifier: KLS20181582
• Study Type: interventional
• Target: 33,995
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension

Keywords

Hypertension; Cardiovascular disease; Dementia; China; Protocol-based treatment; Stroke

Outcome Measures

Primary Outcomes (4)

• Primary Outcome of Phase 1: Hypertension control rate

  The proportion of participants with controlled blood pressure（\< 130/80 mm Hg）

  18 months after baseline

• Primary Outcome of Phase 2: Composite cardiovascular disease outcome

  Record the occurrence of newly diagnosed composite cardiovascular disease

  36 months after baseline

• Primary Outcome of Phase 3: All-cause dementia

  Record all-cause dementia

  48 months after baseline

• Primary Outcome of Extension Study: Composite cardiovascular disease outcome

  Record the occurrence of newly diagnosed composite cardiovascular disease

  Year 7 after baseline

Secondary Outcomes (27)

• Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes

  18 months after baseline

• Secondary Outcome of Phase 1: Hypertension control rate（<140/90 mm)

  18 months after baseline

• Secondary Outcome of Phase 1: Adherence to antihypertensive medication rate

  18 months after baseline

• Secondary Outcome of Phase 2: Stroke

  36 months after baseline

• Secondary Outcome of Phase 2: Myocardial infarction

  36 months after baseline

Study Arms (2)

Experimental Group

EXPERIMENTAL

Village-doctor-led multifaceted intervention

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

Interventions

Village-doctor-led multifaceted intervention OTHER

* 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

Experimental Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Disease Control and Prevention Centre of Chaoyang City: collaborator
• Shengjing Hospital: collaborator
• Chaoyang Central Hospital: collaborator
• Hanzhong People's Hospital: collaborator
• First Hospital of China Medical University: lead
• Tulane University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Tongji Hospital: collaborator
• Disease Control and Prevention Centre of Liaoning Province: collaborator

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Related Publications (12)

• Liu 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. doi: 10.1186/s12916-026-04678-2. Online ahead of print.

  PMID: 41776553 DERIVED

• Guo 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.

  PMID: 41686438 DERIVED

• Sun 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. 2025 Sep 29:S2090-1232(25)00758-1. doi: 10.1016/j.jare.2025.09.054. Online ahead of print.

  PMID: 41033581 DERIVED

• Lu 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.

  PMID: 41018530 DERIVED

• Sun 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.

  PMID: 40643915 DERIVED

• He 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.

  PMID: 40258956 DERIVED

• Sun 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.

  PMID: 40079319 DERIVED

• Sun 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.

  PMID: 38902731 DERIVED

• Guo 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.

  PMID: 38888905 DERIVED

• He 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.

  PMID: 36871573 DERIVED

• Sun 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.

  PMID: 35500594 DERIVED

• Sun 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.

  PMID: 33605981 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Dementia; Stroke

Condition Hierarchy (Ancestors)

Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders

Study Officials

• Yingxian Sun, MD, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessment Committee members will be blinded to outcome assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Cardiology in First Hospital of China Medical University

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 17, 2018
• Study Start: May 8, 2018
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)