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A Randomized Trial of Intensive versus Standard Blood-Pressure Control
Insights
Lowering systolic blood pressure to under 120 mm Hg in high-risk individuals without diabetes significantly reduces cardiovascular events and all-cause mortality. Intensive treatment lowered major adverse cardiovascular events and death, despite increased adverse events like hypotension.
Area of Science:
- Cardiology
- Public Health
- Clinical Trials
Background:
- Optimal systolic blood pressure targets for reducing cardiovascular disease (CVD) morbidity and mortality in non-diabetic individuals are not well-established.
- Previous research has not definitively determined the ideal blood pressure threshold for intensive management in this population.
Purpose of the Study:
- To compare the effectiveness of an intensive systolic blood pressure target (<120 mm Hg) versus a standard target (<140 mm Hg) in preventing major cardiovascular events and death.
- To evaluate the impact of intensive blood pressure management on cardiovascular outcomes in high-risk, non-diabetic adults.
Main Methods:
- A randomized controlled trial involving 9361 participants with systolic blood pressure ≥130 mm Hg and increased CVD risk, but no diabetes.
- Participants were assigned to either intensive treatment (target <120 mm Hg) or standard treatment (target <140 mm Hg).
- The primary composite outcome included myocardial infarction, acute coronary syndromes, stroke, heart failure, or cardiovascular death.
Main Results:
- The intensive treatment group achieved a mean systolic blood pressure of 121.4 mm Hg, compared to 136.2 mm Hg in the standard treatment group.
- The study was stopped early due to a significantly lower rate of the primary composite outcome in the intensive group (1.65% vs. 2.19% annually; HR, 0.75; P<0.001).
- All-cause mortality was also significantly reduced in the intensive group (HR, 0.73; P=0.003), though rates of hypotension, syncope, and kidney injury were higher.
Conclusions:
- Targeting a systolic blood pressure <120 mm Hg in high-risk, non-diabetic patients significantly lowers the risk of major cardiovascular events and all-cause mortality compared to a target <140 mm Hg.
- While intensive treatment offers substantial cardiovascular benefits, it is associated with an increased incidence of certain adverse events, necessitating careful patient selection and monitoring.
Background:
The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain.
Methods:
We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.
Results:
At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P=0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group.
Conclusions:
Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01206062.).
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