Status:
COMPLETED
Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Hypertension
Eligibility:
All Genders
50+ years
Phase:
NA
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...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2023
Estimated Enrollment :
11255 Patients enrolled
Trial Details
Trial ID
NCT04030234
Start Date
September 17 2019
End Date
July 14 2023
Last Update
February 20 2024
Active Locations (1)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100087