Systolic Blood Pressure Intervention Trial
Completed · Not applicable
Conditions studied: Hypertension
In brief
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. The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-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.
Key facts
- Study ID
- NCT01206062
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 9361
- Starts
- 2010-10-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2021-01-08
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
- Presence of clinical or subclinical cardiovascular disease other than stroke
- CKD, defined as eGFR 20 - 59 ml/min/1.73m2
- A Framingham Risk Score for 10-year CVD risk ≥ 15%
- Age greater than 75 years
You may not qualify if…
- 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.
Where it is running
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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