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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

NCT05352633 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2022-06-28

No results posted yet for this study

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).

Conditions

  • Blood Pressure

Interventions

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.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Principal Investigators

  • Jing Li · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352633 on ClinicalTrials.gov