Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Keywords: Intense Pressure Lowering Treatment
Out-of-office Blood Pressure
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2022-04-29
Enrollment: 710
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences of the mean blood pressure during daytime
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
Secondary outcomes:
measure: Proportion of participants with White-coat uncontrolled hypertension
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
measure: Differences of the proportions of participants with White-coat uncontrolled hypertension among different intervention groups
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
measure: Proportion of participants with Masked uncontrolled hypertension
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
measure: Differences of the proportions of participants with Masked uncontrolled hypertension among different intervention groups
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
measure: Differences of mean blood pressure during night-time
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
measure: Differences of 24-hour mean blood pressure
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
measure: Differences of the ratios of night-time and daytime blood pressure
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
measure: Differences of mean systolic blood pressure via home blood pressure monitoring
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
measure: Compare the consistency of clinic-based blood pressure and out-office blood pressure
timeFrame: During the 2-3 years of follow-up of the main trial (ESPRIT)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Jing Li
role: PRINCIPAL_INVESTIGATOR
References: