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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05352633
• Other study ID #: SFLX2021014
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: Jing Li, Ph.D
• Email: jing.li[@]fwoxford.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 710
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Systolic Murmurs

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen, People's Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)