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

National Center for Cardiovascular Diseases

Status: Not yet enrolling

Conditions: Blood Pressure

Treatments: Drug: Standard BP Arm; Drug: Intensive BP Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT05352633

SFLX2021014

Details and patient eligibility

About

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).

Full 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.

Enrollment: 710 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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710 participants in 2 patient groups

Intensive BP Arm

Experimental group

Description:

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.

Treatment:

Drug: Intensive BP Arm

Standard BP Arm

Active Comparator group

Description:

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.

Treatment:

Drug: Standard BP Arm