Status:
COMPLETED
Systolic Blood Pressure Intervention Trial
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
National Institute on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hypertension
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 co...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
9361 Patients enrolled
Trial Details
Trial ID
NCT01206062
Start Date
October 1 2010
End Date
March 1 2019
Last Update
January 8 2021
Active Locations (1)
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1
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157