Hypertension
Conditions
Keywords
Hypertension, Blood pressure target
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.
Interventions
DRUGIntensive 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
DRUGStandard 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.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least ≥50 years old, and 2. 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 3. Prior vascular disease or at high vascular risk 1. 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) 2. Previous stroke 3. Carotid endarterectomy (CE), or carotid stenting 4. Peripheral artery disease (PAD) with revascularization 5. Abdominal aortic aneurysm (AAA) ≥5 cm with repair 6. 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
1. Known secondary cause of hypertension 2. 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 3. One minute standing SBP \<110 mmHg (not applicable if unable to stand) 4. Arm circumference too large or small to allow accurate blood pressure measurement with available devices 5. Proteinuria defined as urine dipstick ≥2+ protein at screening 6. Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy 7. eGFR \<45 ml/min /1.73m2 or end-stage renal disease (ESRD) 8. 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 9. Symptomatic heart failure within the past 6 months or documented left ventricular ejection fraction (by any method) \<35% 10. PCI or CABG planned for the next 6 months 11. 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 12. Any organ transplant 13. Pregnancy, breast-feeding, or of child-bearing potential and not using adequate contraception 14. Any factors judged by local clinic investigators to be likely to limit adherence to interventions. For example, 1. Active alcohol or substance abuse within the last 12 months 2. Plans to move to another place to live for a long time 3. Clinical diagnosis of dementia or mild cognitive impairment (MCI) 15. Currently participation in a clinical trial with an unlicensed drug or device 16. Living in the same household as an already randomized participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with composite of major CVD events | 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
| Measure | Time frame |
|---|---|
| Number of participants with myocardial infarction | 4 years |
| Number of participants with coronary revascularization | 4 years |
| Number of participants with non-coronary revascularization | 4 years |
| Number of participants with chronic or acute decompensated heart failure hospitalization or emergency department visit | 4 years |
| Number of participants with stroke | 4 years |
| Number of participants with cardiovascular death | 4 years |
| Number of participants with all-cause death | 4 years |
| Number of participants with composite outcome of the primary composite with all-cause death | 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 | 4 years |
| Number of participants with all-cause dementia or mild cognitive impairment | 4 years |
| Difference of arteriole-to-venule ratio measured by fundus photography between intensive treatment group and standard treatment group | at 4-year final follow-up visit |
Countries
China
Outcome results
None listed