An interventional study of Intensive BP Arm and Standard BP Arm in Blood Pressure, sponsored by China National Center for Cardiovascular Diseases. Status unknown at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-06-28.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
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).
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.
China National Center for Cardiovascular Diseases is the lead sponsor of 262 studies on the registry; 138 are open to participants now.
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Exclusion Criteria:
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 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 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
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
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
Time frame: During the 2-3 years of follow-up of the main trial (ESPRIT)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 )
Time frame: During the 2-3 years of follow-up of the main trial (ESPRIT)
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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