Systolic Blood Pressure Intervention Trial "SPRINT"
Active, not recruiting
Phase N/A Results N/AEligibility Criteria
Inclusion Criteria
- At least 50 years oldSystolic 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.
View Trial Locations
Recruitment
- Enrollment: 9,250
- Gender: Both
- Minimum Age: 50 Years
- Accepts Healthy Volunteers: Yes
- 1 location, 1 country
Principal Investigators
- David M. Reboussin, PhD
Wake Forest University
- Jackson T Wright, MD
Case Western Reserve University
- Alfred Cheung, MD
University of Utah
