NCT04030234

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11,255 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Intensive BP treatment group	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
DRUG	Standard BP treatment group	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.

Timeline

• Start date: 2019-09-17
• Primary completion: 2023-06-30
• Completion: 2023-07-14
• First posted: 2019-07-23
• Last updated: 2024-02-20

Locations

1 site across 1 country: China