Blood PressureNCT05352633
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
A study testing Intensive BP Arm and Standard BP Arm in people with Blood Pressure, run by China National Center for Cardiovascular Diseases at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Intensive BP Arm and Standard BP Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eligible for the follow up of the main study;
- content to participate in the sub-study.
Who cannot join
- frequently working during night-time;
- the non - dominant arm could not wear 24-hour ambulatory blood pressure monitoring due to radiation therapy or physical impairment;
- keep engaged in out-door activities of high physical intensity, e.g. farming or porter, etc.;
- life expectancy is less than 1 year; such as diagnosed with heart failure, cancer, or end-stage renal disease;
- the difference of clinical systolic pressure between upper arms was more than 10 mmHg;
- unable to use smart-phone to upload family blood pressure monitoring data.
Trial locations and contacts
1 site in 1 country.
Jing Li, Ph.D contact
Xiaofang Yan, M.S. contact
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Ying Sun, B.A., ying.sun@fwoxford.org
About this 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).
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- Intensive BP Arm, Standard BP Arm
- Keywords
- Intense Pressure Lowering Treatment, Out-of-office Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive BP ArmDrug
Also called Control of SBP to <120 mmHg
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 ArmDrug
Also called Control of SBP to <140 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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive BP Arm | Experimental | 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. Receives: Drug: Intensive BP Arm |
| Standard BP Arm | Active comparator | 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. Receives: Drug: Standard BP Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the 2-3 years of follow-up of the main trial (ESPRIT)
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 )
Measured: During the 2-3 years of follow-up of the main trial (ESPRIT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start18 Jul 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
- Investigators
- Jing Li, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352633
- Sponsor's protocol ID
- SFLX2021014
- Status last verified
- Jun 2022
- First submitted
- 5 Apr 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05352633
- Acronym / sponsor ID
- SFLX2021014
- Conditions
- Blood Pressure
- Keywords
- Intense Pressure Lowering Treatment, Out-of-office Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 18 Jul 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive BP Arm | Experimental | Drug: Intensive BP ArmParticipants 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. |
| Standard BP Arm | Active comparator | Drug: Standard BP ArmParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- eligible for the follow up of the main study;
- content to participate in the sub-study.
Key exclusion criteria (6 listed)
- frequently working during night-time;
- the non - dominant arm could not wear 24-hour ambulatory blood pressure monitoring due to radiation therapy or physical impairment;
- keep engaged in out-door activities of high physical intensity, e.g. farming or porter, etc.;
- life expectancy is less than 1 year; such as diagnosed with heart failure, cancer, or end-stage renal disease;
- the difference of clinical systolic pressure between upper arms was more than 10 mmHg;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive BP ArmAlso: Control of SBP to <120 mmHgParticipants 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 | Drug | Intensive BP Arm |
| Standard BP ArmAlso: Control of SBP to <140 mmHgParticipants 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. | Drug | Standard BP Arm |
Primary outcome
Differences of the mean blood pressure during daytime
Time frame: During the 2-3 years of follow-up of the main trial (ESPRIT)
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
9 secondary outcomes
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
Time frame: During the 2-3 years of follow-up of the main trial (ESPRIT)
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
Time frame: During the 2-3 years of follow-up of the main trial (ESPRIT)
Differences of mean blood pressure during night-time
Time frame: During the 2-3 years of follow-up of the main trial (ESPRIT)
Differences of 24-hour mean blood pressure
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
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
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
Time frame: During the 2-3 years of follow-up of the main trial (ESPRIT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Li, Ph.D contact
Xiaofang Yan, M.S. contact
Jing Li principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive BP Arm and Standard BP Arm in people with Blood Pressure, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Li, Ph.D (jing.li@fwoxford.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of the mean blood pressure during daytime (time frame: During the 2-3 years of follow-up of the main trial (ESPRIT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.