Systolic Blood Pressure Intervention Trial

SPRINT strived to enroll about 9250 participants aged ≥ 50 years with SBP ≥130 mm Hg and at
least one additional CVD risk factor. The trial compared 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 were <120 vs <140 mm Hg, respectively, to create a minimum
mean difference of 10 mm Hg between the two randomized groups. The primary hypothesis was
that CVD event rates would be lower in the intensive arm. Participants were recruited at
approximately 90 clinics within 5 clinical center networks (CCNs) over approximately a 2-year
period, and were followed for 4-6 years.

A total of 9361 participants were enrolled. NIH stopped the blood pressure intervention
earlier than originally planned in order to quickly disseminate the significant preliminary
results. Follow-up for cognitive and kidney outcomes continues during the post-intervention
phase through May 2018.

Inclusion Criteria:

- At least 50 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

- 130 - 150 mm Hg on up to 4 medications

Risk (one or more of the following)

1. Presence of clinical or subclinical cardiovascular disease other than stroke

2. CKD, defined as eGFR 20 - 59 ml/min/1.73m2

3. A Framingham Risk Score for 10-year CVD risk ≥ 15%

4. Age greater than 75 years

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 < 20 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.