SPRINT trial

SPRINT trial
Name	SPRINT
Full name	Systolic Blood Pressure Intervention Trial
Acronym	SPRINT
Phase	Clinical trial
Start date	2010
Completion date	2015
Participants	9361
Condition	Hypertension
Interventions	Intensive systolic blood pressure target (<120 mm Hg) vs standard target (<140 mm Hg)
Primary outcome	Composite of myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular death
Sponsor	National Heart, Lung, and Blood Institute

SPRINT trial was a large, randomized, multicenter clinical trial comparing intensive versus standard systolic blood pressure targets in adults at increased cardiovascular risk. The trial enrolled 9,361 participants and reported major cardiovascular and mortality benefits for the intensive target arm, influencing practice and guidelines internationally. Conducted under the auspices of federal research networks and academic centers, the trial design, outcomes, and subsequent guideline impact have been widely discussed across cardiology and public health communities.

Background

The trial was designed amid longstanding debates following observational studies and trials such as Framingham Heart Study, British Medical Research Council trial, and Hypertension Detection and Follow-up Program about optimal systolic blood pressure targets. Concerns raised by investigators influenced by landmark randomized trials like ALLHAT and meta-analyses overseen by organizations including Cochrane Collaboration and World Health Organization shaped protocol planning. The National Heart, Lung, and Blood Institute convened investigators from academic centers including Johns Hopkins Hospital, Harvard Medical School, University of California, San Francisco, and Brigham and Women's Hospital to design a pragmatic trial to evaluate cardiovascular and mortality outcomes.

Methods

SPRINT used a parallel-group randomized design with allocation to an intensive systolic blood pressure target (<120 mm Hg) versus standard target (<140 mm Hg). Enrollment criteria emphasized participants aged 50 years or older with increased cardiovascular risk, drawing recruits from clinical networks like Veterans Health Administration, Kaiser Permanente, and multiple academic medical centers such as Mayo Clinic and University of Pittsburgh Medical Center. The protocol included standardized measurement techniques derived from guidelines from bodies such as American College of Cardiology, American Heart Association, and data safety oversight by a Data and Safety Monitoring Board. Antihypertensive medication regimens incorporated agents from classes introduced in trials like ALLHAT and pharmacologic agents marketed by companies regulated by agencies including Food and Drug Administration. Outcomes were adjudicated by committees modeled on adjudication processes used in trials such as SPRINT-MIND ancillary studies and harmonized with endpoints from trials like SHEP and HOPE.

Results

The trial demonstrated that intensive systolic blood pressure lowering to a goal of <120 mm Hg reduced the primary composite outcome of myocardial infarction, acute coronary syndromes, stroke, heart failure, or cardiovascular death compared with standard management. The intensive arm also showed a significant reduction in all-cause mortality. These findings echoed relative risk reductions reported in prior trials such as HOT and provided new mortality data not demonstrated in some earlier studies like ACCORD. Secondary endpoints and interim analyses were reported at scientific meetings hosted by organizations including American Heart Association and European Society of Cardiology, and published in high-profile journals affiliated with publishers such as The New England Journal of Medicine.

Safety and adverse events

Adverse event monitoring identified higher rates of certain events in the intensive-treatment group, including hypotension, syncope, electrolyte abnormalities, and acute kidney injury. The pattern of adverse events prompted comparisons with safety signals reported in trials such as ACCORD and cohort studies like Framingham Heart Study for renal outcomes. Safety oversight involved consultation with clinical experts from institutions like Cleveland Clinic, Massachusetts General Hospital, and regulatory bodies including National Institutes of Health. Reporting emphasized the need to balance the cardiovascular benefits against potential harms in individual patients, echoing risk–benefit discussions from guidelines developed by American Society of Nephrology and Kidney Disease: Improving Global Outcomes.

Subgroup analyses and secondary outcomes

Prespecified and post hoc subgroup analyses examined effects across age strata, baseline cardiovascular risk, chronic kidney disease status, and frailty measures, with investigators affiliated with centers such as Columbia University, University of Minnesota, and University of North Carolina at Chapel Hill contributing analyses. Notably, older adults including octogenarians showed benefit, informing geriatric practice discussions involving organizations like American Geriatrics Society. Cognitive outcomes and dementia-related secondary analyses linked to ancillary studies like SPRINT-MIND assessed incident cognitive impairment and brain imaging correlates, engaging collaborators from Alzheimer's Association–funded research centers and neuroimaging teams at National Institute on Aging. Subgroup results were contrasted with findings from trials including HYVET and cohort consortia such as CARDIA.

Impact and guideline changes

Results from the trial prompted reassessment of blood pressure targets by guideline-writing bodies including American College of Cardiology, American Heart Association, European Society of Cardiology, and national panels in countries coordinated by agencies like NHS England and Health Canada. The trial influenced updates to hypertension guidelines, reimbursement discussions within systems such as Centers for Medicare & Medicaid Services, and quality metrics used by organizations like Joint Commission. Ongoing debates involve incorporation into practice at institutions including Veterans Health Administration and academic hospitals, and comparison with subsequent evidence syntheses produced by groups such as Cochrane Collaboration and task forces like United States Preventive Services Task Force.

Category:Clinical trials