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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Drug: Intensive BP Arm; Drug: Standard BP Arm

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.

• Study Type: Interventional
• Enrollment (Anticipated): 710
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Li, Ph.D; Email: jing.li@fwoxford.org
• Study Contact Backup: Name: Xiaofang Yan, M.S.; Email: xiaofang.yan@fwoxford.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Ying Sun, B.A.; Email: ying.sun@fwoxford.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive BP Arm; 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; 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; Other Names: Control of SBP to <120 mmHg
Active Comparator: Standard BP Arm; 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; 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.; Other Names: Control of SBP to <140 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with White-coat uncontrolled hypertension	During the 2-3 years of follow-up of the main trial, to examine the 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, to compare the 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, to examine the 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, to compare the 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, to compare the differences of mean blood pressure during night-time among different intervention groups.	During the 2-3 years of follow-up of the main trial (ESPRIT)
Differences of 24-hour mean blood pressure	During the 2-3 years of follow-up of the main trial, to compare the differences of 24-hour mean blood pressure among different intervention groups.	During the 2-3 years of follow-up of the main trial (ESPRIT)
Differences of the ratios of night-time and daytime blood pressure	During the 2-3 years of follow-up of the main trial, to compare the differences of the ratios of night-time and daytime blood pressure among different intervention groups.	During the 2-3 years of follow-up of the main trial (ESPRIT)
Differences of mean systolic blood pressure via home blood pressure monitoring	During the 2-3 years of follow-up of the main trial, to compare the differences of mean systolic blood pressure via home blood pressure monitoring among different intervention groups.	During the 2-3 years of follow-up of the main trial (ESPRIT)
Compare the consistency of clinic-based blood pressure and out-office blood pressure	During the 2-3 years of follow-up of the main trial, among participants from different intervention groups (intensive and standard groups), to compare the consistency of clinic-based blood pressure and out-office blood pressure (mean SBP during daytime vs mean home blood pressure )	During the 2-3 years of follow-up of the main trial (ESPRIT)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen, People's Republic of China
• Investigators: Principal Investigator: Jing Li, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 18, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 24, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 25, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Intense Pressure Lowering Treatment; Out-of-office Blood Pressure
• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs
• Other Study ID Numbers: SFLX2021014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No