Systolic Blood Pressure Intervention Trial

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institute of Neurological Disorders and Stroke (NINDS); National Institute on Aging (NIA); Wake Forest University Health Sciences

Criteria

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.