The Systolic Blood Pressure Intervention Trial (SPRINT) is a two-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk.

Location:

Jacksonville, Fla.

Trial status:
Open for Enrollment
Why is this study being done?

Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function.  SPRINT will randomize about 9250 participants aged ≥ 55 years with SBP ≥130 mm Hg and at least one additional CVD risk factor. The trial will compare the effects of randomization to a treatment program of an intensive SBP goal with randomization to a treatment program of a standard goal. Target SBP goals are <120 vs <140 mm Hg, respectively, to create a minimum mean difference of 10 mm Hg between the two randomized groups. The primary hypothesis is that CVD event rates will be lower in the intensive arm. Participants will be recruited at approximately 90 clinics within 5 clinical center networks (CCNs) over a 2-year period, and will be followed for 4-6 years.

Who is eligible to participate?

Ages Eligible for Study:    55 Years and older   Genders Eligible for Study:    Both   Accepts Healthy Volunteers:    Yes    


Criteria    


Inclusion Criteria:    


At least 55 years old   Systolic blood pressure of    


130 - 180 mm Hg on 0 or 1 medication   130 - 170 mm Hg on up to 2 medications   130 - 160 mm Hg on up to 3 medications   Risk (one or more of the following) a) Presence of clinical or subclinical cardiovascular disease other than stroke    


CKD, defined as eGFR 25 - 59 ml/min/1.73m2   A Framingham Risk Score for 10-year CVD risk ≥ 15%    


Exclusion Criteria:    


An indication for a specific BP lowering medication that the person is not taking and the person has not been documented to be intolerant of the medication class.   Known secondary cause of hypertension that causes concern regarding safety of the protocol.   One minute standing SBP < 110 mm Hg.   Proteinuria in the following ranges (based on a measurement within the past 6 months)    


24 hour urinary protein excretion ≥1 g/day, or   24 hour urinary albumin excretion ≥ 600 mg/day, or   spot urine protein/creatinine ratio ≥ 1 g/g creatinine, or   spot urine albumin/creatinine ratio ≥ 600 mg/g creatinine, or   urine dipstick ≥ 2+ protein   Arm circumference too large or small to allow accurate blood pressure measurement with available devices   Diabetes mellitus,   History of stroke (not CE or stenting)   Diagnosis of polycystic kidney disease   Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy   eGFR < 25 ml/min /1.73m2 or end-stage renal disease (ESRD)   Cardiovascular event or procedure (as defined above as clinical CVD for study entry) or hospitalization for unstable angina within last 3 months   Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) < 35%   A medical condition likely to limit survival to less than 3 years or a malignancy other than non-melanoma skin cancer within the last 2 years   Any factors judged by the clinic team to be likely to limit adherence to interventions.   Failure to obtain informed consent from participant   Currently participating in another clinical trial (intervention study). Note: Patient must wait until the completion of his/her activities or the completion of the other trial before being screened for SPRINT.   Living in the same household as an already randomized SPRINT participant   Any organ transplant   Unintentional weight loss > 10% in last 6 months   Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control.    

What is involved?

Subjects will meet with the SPRINT medical team monthly for the first three months and then quarterly after that.  These visits will include: clinic blood pressure visits, blood tests, electrocardiograms, cognitive (memory) tests, study questionnaires, and the dispensing of blood pressure medications (at no cost to the patient).  

How long is the study?

Subjects will be involved for 4-8 years.

Principal Investigator: William E. Haley, MD 3-8775

IRB Number:
10-004686