HypertensionESPRITNCT04030234
Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study
A study testing Intensive BP treatment group and Standard BP treatment group in people with Hypertension, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Intensive BP treatment group and Standard BP treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,255 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2019to 14 Jul 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least ≥50 years old, and
- Systolic blood pressure (SBP): (having documentation of SBP to meet the criteria below on 2 consecutive visits)
- SBP: 130-180 mmHg on 0 or 1 medication
- SBP: 130-170 mmHg on up to 2 medications
- SBP: 130-160 mmHg on up to 3 medications
- SBP: 130-150 mmHg on up to 4 medications, and
Show all 17Show fewer
- Prior vascular disease or at high vascular risk
- Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), at least a 50% diameter stenosis of a coronary, chest pain with objective evidence of myocardial ischemia (load electrocardiogram or load image examination indicated myocardial ischemia)
- Previous stroke
- Carotid endarterectomy (CE), or carotid stenting
- Peripheral artery disease (PAD) with revascularization
- Abdominal aortic aneurysm (AAA) ≥5 cm with repair
- Combine with no less than two risk factors below
- ≥60 years old male or ≥65 years old female
- Diabetes
- Dyslipidemia (total cholesterol >200 mg/dL [5.2 mmol/L] or LDL-C >130 mg/dL [3.4 mmol/L] or HDL-C < 40 mg/dL [1.0 mmol/L])
- Current smoking (smoke more than a cigarette every day in the past 12 months)
Who cannot join
- Known secondary cause of hypertension
- An indication for a specific BP lowering medication that the participant is not taking and the participant has not been documented to be intolerant of the medication class
- One minute standing SBP <110 mmHg (not applicable if unable to stand)
- Arm circumference too large or small to allow accurate blood pressure measurement with available devices
- Proteinuria defined as urine dipstick ≥2+ protein at screening
- Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
Show all 19Show fewer
- eGFR <45 ml/min /1.73m2 or end-stage renal disease (ESRD)
- Previous MI, stroke, or hospitalization for angina, PCI, CABG, CE or carotid stenting, PAD with revascularization, AAA≥5 cm with repair within last 3 months
- Symptomatic heart failure within the past 6 months or documented left ventricular ejection fraction (by any method) <35%
- PCI or CABG planned for the next 6 months
- A medical condition likely to limit survival to less than 3 years, or a cancer (other than non-melanoma skin cancer) diagnosed and treated within the past two years that, in the judgment of local clinical investigators, would compromise a participant's ability to comply with the protocol and complete the trial
- Any organ transplant
- Pregnancy, breast-feeding, or of child-bearing potential and not using adequate contraception
- Any factors judged by local clinic investigators to be likely to limit adherence to interventions. For example,
- Active alcohol or substance abuse within the last 12 months
- Plans to move to another place to live for a long time
- Clinical diagnosis of dementia or mild cognitive impairment (MCI)
- Currently participation in a clinical trial with an unlicensed drug or device
- Living in the same household as an already randomized participant
Trial locations and contacts
1 site in 1 country.
About this study
This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target <120 mmHg versus <140 mmHg.
Read the detailed description
This study is a multicenter, open-label, randomized controlled trial, which will randomize participants aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk. The study will compare the effects on the incidence of major cardiovascular events of allocation to achieve an intensive SBP goal (SBP <120 mmHg) with a standard SBP goal (SBP <140 mmHg) in four years of follow up.
- Conditions
- Hypertension
- Being tested
- Intensive BP treatment group, Standard BP treatment group
- Keywords
- Hypertension, Blood pressure target
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive BP treatment groupDrug
Also called Control of SBP to <120 mmHg
Participants in the Intensive BP treatment group have a goal of SBP <120 mmHg. It is recommended to provide long-acting antihypertensive medications, that is once daily, unless other medication delivery frequency is needed. The local investigator may select among the available study antihypertensive medications. Other drugs not supplied by the trial may also be used as the investigator determines appropriate.
One or more medications from the following classes of agents will be provided by the study for use in managing participants in both randomization groups to achieve study goals:
Angiotension converting enzyme (ACE)-inhibitors; Angiotension receptor blockers (ARBs); Thiazide-type diuretics; Loop diuretics; Potassium-sparing diuretics; Beta-blockers; Calcium channel blockers (CCBs); Direct vasodilators; Alpha1-receptor blockers; Sympatholytics
Standard BP treatment groupDrug
Also called Control of SBP to <140 mmHg
Participants in the Standard BP treatment group have a goal of SBP <140 mmHg. The same medications used in the Intensive BP treatment group will be used for the Standard BP treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Intensive treatment group | Experimental | Participants randomized into the Intensive treatment group will have a goal of SBP <120 mmHg. A two- or three-drug regimen should be initiated at randomization for most participants. Drug doses should be increased and/or additional antihypertensive medications should be added at each visit in the intensive treatment group, usually at monthly intervals, until the participant's goal of <120 mmHg has been reached or the local investigator decides no further antihypertensive medications may be added. Receives: Drug: Intensive BP treatment group |
| Standard treatment group | Active comparator | Participants randomized into the Standard treatment group will have a goal of SBP <140 mmHg. It is expected to achieve a SBP of 135-139 mmHg in as many participants as possible. Medication dose titration or addition of another drug is indicated if SBP is ≥160 mmHg at a single visit or is ≥140 mmHg at two consecutive visits. Down titration should be carried out if the SBP is <130 mmHg at a single visit or <135 mmHg at two consecutive visits. Receives: Drug: Standard BP treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with composite of major CVD events
Composite outcome of myocardial infarction, coronary or non-coronary revascularization, chronic or acute decompensated heart failure hospitalization or emergency department visit, stroke, or death from cardiovascular disease
Measured: 4 years
Secondary outcomes (11)
Number of participants with myocardial infarction
Measured: 4 years
Number of participants with coronary revascularization
Measured: 4 years
Number of participants with non-coronary revascularization
Measured: 4 years
Number of participants with chronic or acute decompensated heart failure hospitalization or emergency department visit
Measured: 4 years
Number of participants with stroke
Measured: 4 years
Number of participants with cardiovascular death
Measured: 4 years
Number of participants with all-cause death
Measured: 4 years
Number of participants with composite outcome of the primary composite with all-cause death
Measured: 4 years
Number of participants with end-stage kidney disease (ESKD), a sustained decline in eGFR to <10 mL/min/1.73m2, renal death, or a sustained decline of ≥40% in eGFR from randomization
Measured: 4 years
Number of participants with all-cause dementia or mild cognitive impairment
Measured: 4 years
Difference of arteriole-to-venule ratio measured by fundus photography between intensive treatment group and standard treatment group
Measured: at 4-year final follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start17 Sep 2019
- Primary completion30 Jun 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11,255 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jing Li, MD, PhD, Principal investigator, National Center for Cardiovascular DiseasesJiamin Liu, MD, Principal investigator, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030234
- Sponsor's protocol ID
- 2018YFC1312400
- Acronym
- ESPRIT
- Status last verified
- Jan 2024
- First submitted
- 17 Jul 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peng Y, Li Y, Li S, Zhang L, Zhao L, Liu J, Yan X, Liu J, Chai Z, Liang X, Tian C, Huo F, Wu L, Chen X, Che H, Zhang M, Duan R, Wang H, Liu X, Li Z, Liu Z, Wu L, Zhou W, Zhang H, Li J. Achieving Intensive Blood Pressure Control in High-Risk Patients: Implementation Insights From the ESPRIT Trial. J Am Coll Cardiol. 2026 May 12;87(18):2450-2470. doi: 10.1016/j.jacc.2026.01.083. Epub 2026 Apr 1.
PubMed 41920135Wang B, Sun Y, Li Y, Wu L, Peng Y, Li S, Ge J, Zhang L, Zhao L, Liu J, Su S, Zhang B, Liu Y, Ma X, Zuo Z, Zhang H, Wang Y, Liu J, Li J. Intensive BP Control and Cognitive Function: A Randomized Clinical Trial. Hypertension. 2026 Apr;83(4):e26572. doi: 10.1161/HYPERTENSIONAHA.125.26572. Epub 2026 Feb 26.
PubMed 41744069Huang X, Zhang H, Li Y, Ge J, Sun Y, Zhang L, Zhao L, Liu J, Zhang C, Du J, Li Y, Zhang H, Hao F, Wang Q, Xu W, Liu J, Li J. Modest Effects of Intensive Blood Pressure-Lowering on Quality of Life in Patients at High Cardiovascular Risk: The ESPRIT Trial. J Am Coll Cardiol. 2025 Oct 28;86(17):1392-1401. doi: 10.1016/j.jacc.2025.06.010. Epub 2025 Oct 17.
PubMed 41105075Wang B, Shi D, Zhang Z, Zhang L, Sun Y, Liu J, Yan X, Jing J, Li J, Song J, Li Y, Li G, Zhang L, Wang Z, Chen J, Zhang W, Cai S, Han S, Luan T, Yi S, Su S, Du J, Kou X, Liu J, Dai X, Li N, Zhu J, Tang C, Liu S, Su H, Liu Y, Mao Y, Yang X, He M, Zhang Q, Li J. Effect of Intensive Blood Pressure Lowering Treatment on Retinal Microvasculature: Secondary Analysis From ESPRIT. J Am Coll Cardiol. 2025 Oct 28;86(17):1377-1388. doi: 10.1016/j.jacc.2025.05.020. Epub 2025 Oct 17.
PubMed 41105073Li S, Peng Y, Li Y, Sun Y, Yan X, Zhang L, Liu J, Zhao L, Liu J, Qian J, Zhai N, Dong L, Ruan J, Zhang P, Wei X, Liu Y, Ma Q, Huang W, Zhang Q, An C, Liu J, Sheng L, Zhang H, Li J; ESPRIT Investigators. Effects of Intensive Blood Pressure Control in Patients With Frailty: A Post Hoc Analysis From ESPRIT. J Am Coll Cardiol. 2026 Jan 6;87(1):4-16. doi: 10.1016/j.jacc.2025.08.092. Epub 2025 Oct 15.
PubMed 41091084Liu J, Li Y, Ge J, Yan X, Zhang H, Zheng X, Lu J, Li X, Gao Y, Lei L, Liu J, Li J; ESPRIT Collaborative Group. Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial. Lancet. 2024 Jul 20;404(10449):245-255. doi: 10.1016/S0140-6736(24)01028-6. Epub 2024 Jun 27.
PubMed 38945140Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
PubMed 32905623
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study
- ClinicalTrials.gov ID
- NCT04030234
- Acronym / sponsor ID
- ESPRIT / 2018YFC1312400
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure target
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,255 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 23 Jul 2019 (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.
This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target <120 mmHg versus <140 mmHg.
Detailed description
This study is a multicenter, open-label, randomized controlled trial, which will randomize participants aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk. The study will compare the effects on the incidence of major cardiovascular events of allocation to achieve an intensive SBP goal (SBP <120 mmHg) with a standard SBP goal (SBP <140 mmHg) in four years of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment group | Experimental | Drug: Intensive BP treatment groupParticipants randomized into the Intensive treatment group will have a goal of SBP <120 mmHg. A two- or three-drug regimen should be initiated at randomization for most participants. Drug doses should be increased and/or additional antihypertensive medications should be added at each visit in the intensive treatment group, usually at monthly intervals, until the participant's goal of <120 mmHg has been reached or the local investigator decides no further antihypertensive medications may be added. |
| Standard treatment group | Active comparator | Drug: Standard BP treatment groupParticipants randomized into the Standard treatment group will have a goal of SBP <140 mmHg. It is expected to achieve a SBP of 135-139 mmHg in as many participants as possible. Medication dose titration or addition of another drug is indicated if SBP is ≥160 mmHg at a single visit or is ≥140 mmHg at two consecutive visits. Down titration should be carried out if the SBP is <130 mmHg at a single visit or <135 mmHg at two consecutive visits. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- At least ≥50 years old, and
- Systolic blood pressure (SBP): (having documentation of SBP to meet the criteria below on 2 consecutive visits)
- Prior vascular disease or at high vascular risk
Key exclusion criteria (19 listed)
- Known secondary cause of hypertension
- An indication for a specific BP lowering medication that the participant is not taking and the participant has not been documented to be intolerant of the medication class
- One minute standing SBP <110 mmHg (not applicable if unable to stand)
- Arm circumference too large or small to allow accurate blood pressure measurement with available devices
- Proteinuria defined as urine dipstick ≥2+ protein at screening
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 |
|---|---|---|
| Intensive BP treatment groupAlso: Control of SBP to <120 mmHgParticipants in the Intensive BP treatment group have a goal of SBP <120 mmHg. It is recommended to provide long-acting antihypertensive medications, that is once daily, unless other medication delivery frequency is needed. The local investigator may select among the available study antihypertensive medications. Other drugs not supplied by the trial may also be used as the investigator determines appropriate. One or more medications from the following classes of agents will be provided by the study for use in managing participants in both randomization groups to achieve study goals: Angiotension converting enzyme (ACE)-inhibitors; Angiotension receptor blockers (ARBs); Thiazide-type diuretics; Loop diuretics; Potassium-sparing diuretics; Beta-blockers; Calcium channel blockers (CCBs); Direct vasodilators; Alpha1-receptor blockers; Sympatholytics | Drug | Intensive treatment group |
| Standard BP treatment groupAlso: Control of SBP to <140 mmHgParticipants in the Standard BP treatment group have a goal of SBP <140 mmHg. The same medications used in the Intensive BP treatment group will be used for the Standard BP treatment group. | Drug | Standard treatment group |
Primary outcome
Number of participants with composite of major CVD events
Time frame: 4 years
Composite outcome of myocardial infarction, coronary or non-coronary revascularization, chronic or acute decompensated heart failure hospitalization or emergency department visit, stroke, or death from cardiovascular disease
11 secondary outcomes
Number of participants with myocardial infarction
Time frame: 4 years
Number of participants with coronary revascularization
Time frame: 4 years
Number of participants with non-coronary revascularization
Time frame: 4 years
Number of participants with chronic or acute decompensated heart failure hospitalization or emergency department visit
Time frame: 4 years
Number of participants with stroke
Time frame: 4 years
Number of participants with cardiovascular death
Time frame: 4 years
Number of participants with all-cause death
Time frame: 4 years
Number of participants with composite outcome of the primary composite with all-cause death
Time frame: 4 years
Number of participants with end-stage kidney disease (ESKD), a sustained decline in eGFR to <10 mL/min/1.73m2, renal death, or a sustained decline of ≥40% in eGFR from randomization
Time frame: 4 years
Number of participants with all-cause dementia or mild cognitive impairment
Time frame: 4 years
Difference of arteriole-to-venule ratio measured by fundus photography between intensive treatment group and standard treatment group
Time frame: at 4-year final follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 41920135Peng Y, Li Y, Li S, Zhang L, Zhao L, Liu J, Yan X, Liu J, Chai Z, Liang X, Tian C, Huo F, Wu L, Chen X, Che H, Zhang M, Duan R, Wang H, Liu X, Li Z, Liu Z, Wu L, Zhou W, Zhang H, Li J. Achieving Intensive Blood Pressure Control in High-Risk Patients: Implementation Insights From the ESPRIT Trial. J Am Coll Cardiol. 2026 May 12;87(18):2450-2470. doi: 10.1016/j.jacc.2026.01.083. Epub 2026 Apr 1.
- Derived from this study: PubMed 41744069Wang B, Sun Y, Li Y, Wu L, Peng Y, Li S, Ge J, Zhang L, Zhao L, Liu J, Su S, Zhang B, Liu Y, Ma X, Zuo Z, Zhang H, Wang Y, Liu J, Li J. Intensive BP Control and Cognitive Function: A Randomized Clinical Trial. Hypertension. 2026 Apr;83(4):e26572. doi: 10.1161/HYPERTENSIONAHA.125.26572. Epub 2026 Feb 26.
- Derived from this study: PubMed 41105075Huang X, Zhang H, Li Y, Ge J, Sun Y, Zhang L, Zhao L, Liu J, Zhang C, Du J, Li Y, Zhang H, Hao F, Wang Q, Xu W, Liu J, Li J. Modest Effects of Intensive Blood Pressure-Lowering on Quality of Life in Patients at High Cardiovascular Risk: The ESPRIT Trial. J Am Coll Cardiol. 2025 Oct 28;86(17):1392-1401. doi: 10.1016/j.jacc.2025.06.010. Epub 2025 Oct 17.
- Derived from this study: PubMed 41105073Wang B, Shi D, Zhang Z, Zhang L, Sun Y, Liu J, Yan X, Jing J, Li J, Song J, Li Y, Li G, Zhang L, Wang Z, Chen J, Zhang W, Cai S, Han S, Luan T, Yi S, Su S, Du J, Kou X, Liu J, Dai X, Li N, Zhu J, Tang C, Liu S, Su H, Liu Y, Mao Y, Yang X, He M, Zhang Q, Li J. Effect of Intensive Blood Pressure Lowering Treatment on Retinal Microvasculature: Secondary Analysis From ESPRIT. J Am Coll Cardiol. 2025 Oct 28;86(17):1377-1388. doi: 10.1016/j.jacc.2025.05.020. Epub 2025 Oct 17.
- Derived from this study: PubMed 41091084Li S, Peng Y, Li Y, Sun Y, Yan X, Zhang L, Liu J, Zhao L, Liu J, Qian J, Zhai N, Dong L, Ruan J, Zhang P, Wei X, Liu Y, Ma Q, Huang W, Zhang Q, An C, Liu J, Sheng L, Zhang H, Li J; ESPRIT Investigators. Effects of Intensive Blood Pressure Control in Patients With Frailty: A Post Hoc Analysis From ESPRIT. J Am Coll Cardiol. 2026 Jan 6;87(1):4-16. doi: 10.1016/j.jacc.2025.08.092. Epub 2025 Oct 15.
- Derived from this study: PubMed 38945140Liu J, Li Y, Ge J, Yan X, Zhang H, Zheng X, Lu J, Li X, Gao Y, Lei L, Liu J, Li J; ESPRIT Collaborative Group. Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial. Lancet. 2024 Jul 20;404(10449):245-255. doi: 10.1016/S0140-6736(24)01028-6. Epub 2024 Jun 27.
- Derived from this study: PubMed 36398903Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
- Derived from this study: PubMed 32905623Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
- Individual participant dataSharing planned: Undecided
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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.
Jing Li, MD, PhD principal investigator
National Center for Cardiovascular Diseases
Jiamin Liu, MD principal investigator
National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive BP treatment group and Standard BP treatment group 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 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. 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?
Number of participants with composite of major CVD events (time frame: 4 years). 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 NCT04030234, which also lists 8 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 20 Feb 2024.