Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study

NCT04030234 | Completed

• 1 other identifier: 2018YFC1312400
• Study Type: interventional
• Target: 11,255
• Locations: 1 country
• Sites: 1

Brief 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 target \<120 mmHg versus \<140 mmHg.

Conditions

Hypertension

Keywords

Hypertension; Blood pressure target

Outcome Measures

Primary Outcomes (1)

• 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

  4 years

Secondary Outcomes (11)

• Number of participants with myocardial infarction

  4 years

• Number of participants with coronary revascularization

  4 years

• Number of participants with non-coronary revascularization

  4 years

• Number of participants with chronic or acute decompensated heart failure hospitalization or emergency department visit

  4 years

• Number of participants with stroke

  4 years

Study Arms (2)

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.

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.

Drug: Standard BP treatment group

Interventions

Intensive BP treatment group DRUG

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

Also known as: Control of SBP to <120 mmHg

Intensive treatment group

Standard BP treatment group DRUG

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.

Also known as: Control of SBP to <140 mmHg

Standard treatment group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, 100087, China

Location

Related Publications (6)

• Huang 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.

  PMID: 41105075 DERIVED

• Wang 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.

  PMID: 41105073 DERIVED

• Li 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.

  PMID: 41091084 DERIVED

• Liu 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.

  PMID: 38945140 DERIVED

• Saiz 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.

  PMID: 36398903 DERIVED

• Saiz 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.

  PMID: 32905623 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jing Li, MD, PhD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

• Jiamin Liu, MD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 23, 2019
• Study Start: September 17, 2019
• Primary Completion: June 30, 2023
• Study Completion: July 14, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

CN (1)