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出境医 / 临床实验 / Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study (ESPRIT)
Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study (ESPRIT)
Study Description
Brief Summary:
This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target <120 mmHg versus <140 mmHg.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension | Drug: Intensive BP treatment group Drug: Standard BP treatment group | Not Applicable |
Detailed Description:
This study is a multicenter, open-label, randomized controlled trial, which will randomize participants aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk. The study will compare the effects on the incidence of major cardiovascular events of allocation to achieve an intensive SBP goal (SBP <120 mmHg) with a standard SBP goal (SBP <140 mmHg) in four years of follow up.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 17492 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study |
| Estimated Study Start Date : | August 1, 2019 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intensive treatment group
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.
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Drug: Intensive BP treatment group
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 Other Name: Control of SBP to <120 mmHg
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Active Comparator: Standard treatment group
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.
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Drug: Standard BP treatment group
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.
Other Name: Control of SBP to <140 mmHg
|
Outcome Measures
Primary Outcome Measures :
- Number of participants with composite of major CVD events [ Time Frame: 4 years ]Composite outcome of myocardial infarction, coronary or non-coronary revascularization, chronic or acute decompensated heart failure hospitalization or emergency department visit, stroke, or death from cardiovascular disease
Secondary Outcome Measures :
- Number of participants with myocardial infarction [ Time Frame: 4 years ]
- Number of participants with coronary revascularization [ Time Frame: 4 years ]
- Number of participants with non-coronary revascularization [ Time Frame: 4 years ]
- Number of participants with chronic or acute decompensated heart failure hospitalization or emergency department visit [ Time Frame: 4 years ]
- Number of participants with stroke [ Time Frame: 4 years ]
- Number of participants with cardiovascular death [ Time Frame: 4 years ]
- Number of participants with all-cause death [ Time Frame: 4 years ]
- Number of participants with composite outcome of the primary composite with all-cause death [ Time Frame: 4 years ]
- Number of participants with end-stage kidney disease (ESKD), a sustained decline in eGFR to <10 mL/min/1.73m2, renal death, or a sustained decline of ≥40% in eGFR from randomization [ Time Frame: 4 years ]
- Number of participants with all-cause dementia or mild cognitive impairment [ Time Frame: 4 years ]
Eligibility Criteria
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least ≥50 years old, and
-
Systolic blood pressure (SBP): (having documentation of SBP to meet the criteria below on 2 consecutive visits)
- SBP: 130-180 mmHg on 0 or 1 medication
- SBP: 130-170 mmHg on up to 2 medications
- SBP: 130-160 mmHg on up to 3 medications
- SBP: 130-150 mmHg on up to 4 medications, and
-
Prior vascular disease or at high vascular risk
- Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), at least a 50% diameter stenosis of a coronary, chest pain with objective evidence of myocardial ischemia (load electrocardiogram or load image examination indicated myocardial ischemia)
- Previous stroke
- Carotid endarterectomy (CE), or carotid stenting
- Peripheral artery disease (PAD) with revascularization
- Abdominal aortic aneurysm (AAA) ≥5 cm with repair
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Combine with no less than two risk factors below
- ≥60 years old male or ≥65 years old female
- Diabetes
- Dyslipidemia (total cholesterol >200 mg/dL [5.2 mmol/L] or LDL-C >130 mg/dL [3.4 mmol/L] or HDL-C < 40 mg/dL [1.0 mmol/L])
- Current smoking (smoke more than a cigarette every day in the past 12 months)
Exclusion Criteria:
- Known secondary cause of hypertension
- An indication for a specific BP lowering medication that the participant is not taking and the participant has not been documented to be intolerant of the medication class
- One minute standing SBP <110 mmHg (not applicable if unable to stand)
- Arm circumference too large or small to allow accurate blood pressure measurement with available devices
- Proteinuria defined as urine dipstick ≥2+ protein at screening
- Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
- eGFR <45 ml/min /1.73m2 or end-stage renal disease (ESRD)
- Previous MI, stroke, or hospitalization for angina, PCI, CABG, CE or carotid stenting, PAD with revascularization, AAA≥5 cm with repair within last 3 months
- Symptomatic heart failure within the past 6 months or documented left ventricular ejection fraction (by any method) <35%
- PCI or CABG planned for the next 6 months
- A medical condition likely to limit survival to less than 3 years, or a cancer (other than non-melanoma skin cancer) diagnosed and treated within the past two years that, in the judgment of local clinical investigators, would compromise a participant's ability to comply with the protocol and complete the trial
- Any organ transplant
- Pregnancy, breast-feeding, or of child-bearing potential and not using adequate contraception
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Any factors judged by local clinic investigators to be likely to limit adherence to interventions. For example,
- Active alcohol or substance abuse within the last 12 months
- Plans to move to another place to live for a long time
- Clinical diagnosis of dementia or mild cognitive impairment (MCI)
- Currently participation in a clinical trial with an unlicensed drug or device
- Living in the same household as an already randomized participant
Contacts and Locations
Contacts
| Contact: Jing Li, MD, PhD | +86 (10) 6086 6077 | jing.li@fwoxford.org | |
| Contact: Xinghe Huang, PhD | +86 18800120831 | xinghe.huang@fwoxford.org |
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
| Principal Investigator: | Jing Li, MD, PhD | National Center for Cardiovascular Diseases | |
| Principal Investigator: | Jiamin Liu, MD | National Center for Cardiovascular Diseases |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 17, 2019 | ||||||||
| First Posted Date ICMJE | July 23, 2019 | ||||||||
| Last Update Posted Date | July 29, 2019 | ||||||||
| Estimated Study Start Date ICMJE | August 1, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of participants with composite of major CVD events [ Time Frame: 4 years ] Composite outcome of myocardial infarction, coronary or non-coronary revascularization, chronic or acute decompensated heart failure hospitalization or emergency department visit, stroke, or death from cardiovascular disease
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| Original Primary Outcome Measures ICMJE |
Number of participants with composite of major CVD events [ Time Frame: 4 years ] Composite outcome of non-fatal myocardial infarction, coronary or non-coronary revascularization, non-fatal chronic or acute decompensated heart failure hospitalization or emergency department visit, non-fatal stroke, or death from cardiovascular disease
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study | ||||||||
| Official Title ICMJE | Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study | ||||||||
| Brief Summary | This trial aims to assess, in patients aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk, the effects on the incidence of major cardiovascular events during the scheduled treatment period of greater reduction in blood pressure with a SBP target <120 mmHg versus <140 mmHg. | ||||||||
| Detailed Description | This study is a multicenter, open-label, randomized controlled trial, which will randomize participants aged ≥50 years with an average baseline SBP ≥130 mmHg and a previous history of cardiovascular diseases or at high vascular risk. The study will compare the effects on the incidence of major cardiovascular events of allocation to achieve an intensive SBP goal (SBP <120 mmHg) with a standard SBP goal (SBP <140 mmHg) in four years of follow up. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Hypertension | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Saiz LC, Gorricho J, Garjón J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9:CD010315. doi: 10.1002/14651858.CD010315.pub4. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
17492 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2024 | ||||||||
| Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04030234 | ||||||||
| Other Study ID Numbers ICMJE | 2018YFC1312400 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | China National Center for Cardiovascular Diseases | ||||||||
| Study Sponsor ICMJE | China National Center for Cardiovascular Diseases | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | China National Center for Cardiovascular Diseases | ||||||||
| Verification Date | July 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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