NCT05352633

Effects of Intensive Systolic Blood Pressure Lowering Treatment on Out-of-office Blood Pressure - an Ancillary Study to Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 710 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effect of intensive treatment (a target clinic based systolic blood pressure(BP) \<120mmHg) on 24-hour ambulatory blood pressure and home blood pressure, as well as the effect on White-coat uncontrolled hypertension and masked uncontrolled hypertension, compared with standard treatment (a target clinic based systolic BP \<140mmHg).

Detailed description

This study aims to evaluate the effect of intensive treatment (a target clinic based systolic BP \<120mmHg) on 24-hour ambulatory blood pressure and home blood pressure, as well as the effect on White-coat uncontrolled hypertension and masked uncontrolled hypertension, compared with standard treatment (a target clinic based systolic BP \<140mmHg). The population of this study is from an ongoing multi-centre open label clinical trial which evaluated the effect of intensive systolic hypertension treatment on major cardiac events (ESPRIT study). ESPRIT study enrolled patients with high risk of cardiovascular disease, who were aged≥50 years old with a systolic BP≥130 mmHg, and assigned them randomly to intense hypertension group (a target clinic based systolic BP \<120mmHg) or standard hypertension group (a target clinic based systolic BP \<140mmHg), with a 3-year follow-up, evaluating the effect of intense hypertension treatment on major cardiac events. From those eligible ones for the trial, the investigators plan to select 710 to participate in this study. During the 2-3 years of follow-up of the main trial, the participants will be monitored using 24-hour ambulatory blood pressure monitoring, meanwhile one-week home blood pressure monitoring will also be conducted. The two monitoring approaches will be performed twice; once every half year, based on which this study will evaluate the effect of intensive hypertension treatment on 24-hour ambulatory blood pressure and home blood pressure, as well as the effect on White-coat uncontrolled hypertension and masked uncontrolled hypertension.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DRUG	Intensive BP Arm	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 Arm	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: 2022-07-18
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-04-29
• Last updated: 2022-06-28

Locations

1 site across 1 country: China