Valsartan treatment targeting a systolic blood pressure of <140 mmHg compared to <150 mmHg will be evaluated for its effect on cardiovascular events in 3,000 elderly patients with isolated systolic hypertension.
RCT (n=3,000)
Minimization method
Yes
Does targeting a systolic blood pressure below 140 mmHg compared to below 150 mmHg reduce the incidence of cardiovascular events in elderly patients with isolated systolic hypertension treated with valsartan?
The VALISH study is designed to determine the optimal systolic blood pressure target (<140 mmHg vs <150 mmHg) for elderly patients with isolated systolic hypertension.
Although antihypertensive therapy has been proven to reduce cardiovascular morbidity and mortality, it is unclear how much blood pressure should be decreased in elderly patients with hypertension. The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study is a multicenter parallel-group study comparing the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg, under treatment with valsartan, an angiotensin II receptor blocker, as an initial antihypertensive drug in elderly patients with isolated systolic hypertension. The number of patients to be recruited is 3,000 and the duration of follow-up is at least 2 years. This 3,000-patient trial was designed with a two-sided alpha level of 0.05 and 80% power to detect the difference in incidence of cardiovascular events between the target blood pressure levels based on estimation of the cardiovascular events ratio as 21.5/1,000 patient-years and 29.1/1,000 patient-years for the two blood pressure levels. The VALISH study, a large-scale investigator-initiated trial in Japan, will determine whether age should be considered in setting target blood pressure in treatment of isolated systolic hypertension in elderly patients.
Ogihara et al. (Thu,) conducted a rct in Isolated systolic hypertension (n=3,000). Valsartan (target SBP <140 mmHg) vs. Valsartan (target SBP <150 mmHg) was evaluated on Composite of cardiovascular events (sudden death, fatal or nonfatal stroke, fatal or nonfatal myocardial infarction, death due to heart failure, other cardiovascular death, unplanned hospitalization for cardiovascular disease, and renal disorder). Valsartan treatment targeting a systolic blood pressure of <140 mmHg compared to <150 mmHg will be evaluated for its effect on cardiovascular events in 3,000 elderly patients with isolated systolic hypertension.
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