Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing RIsk of Vascular evenTs (ESPRIT) Study (ESPRIT)
Hypertension
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Blood pressure target
Eligibility 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
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
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
Sites / Locations
- Fuwai Hospital, Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intensive treatment group
Standard 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.
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.