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 | Unknown DMC

• 1 other identifier: SFLX2021014
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intense Pressure Lowering Treatment; Out-of-office Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Differences of the mean blood pressure during daytime

  During the 2-3 years of follow-up of the main trial, to compare the differences of the mean blood pressure during daytime among different intervention groups

  During the 2-3 years of follow-up of the main trial (ESPRIT)

Secondary Outcomes (9)

• Proportion of participants with White-coat uncontrolled hypertension

  During the 2-3 years of follow-up of the main trial (ESPRIT)

• Differences of the proportions of participants with White-coat uncontrolled hypertension among different intervention groups

  During the 2-3 years of follow-up of the main trial (ESPRIT)

• Proportion of participants with Masked uncontrolled hypertension

  During the 2-3 years of follow-up of the main trial (ESPRIT)

• Differences of the proportions of participants with Masked uncontrolled hypertension among different intervention groups

  During the 2-3 years of follow-up of the main trial (ESPRIT)

• Differences of mean blood pressure during night-time

  During the 2-3 years of follow-up of the main trial (ESPRIT)

Study Arms (2)

Intensive BP Arm

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 Arm

Standard BP Arm

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 Arm

Interventions

Intensive BP Arm 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 BP Arm

Standard BP Arm 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 BP Arm

Eligibility Criteria

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

You may qualify if:

• eligible for the follow up of the main study;
• content to participate in the sub-study.

You may not qualify if:

• frequently working during night-time;
• the non - dominant arm could not wear 24-hour ambulatory blood pressure monitoring due to radiation therapy or physical impairment;
• keep engaged in out-door activities of high physical intensity, e.g. farming or porter, etc.;
• life expectancy is less than 1 year; such as diagnosed with heart failure, cancer, or end-stage renal disease;
• the difference of clinical systolic pressure between upper arms was more than 10 mmHg;
• unable to use smart-phone to upload family blood pressure monitoring data.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Study Officials

• Jing Li

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li, Ph.D

CONTACT

jing.li@fwoxford.org

Xiaofang Yan, M.S.

CONTACT

xiaofang.yan@fwoxford.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 29, 2022
• Study Start: July 18, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

CN (1)