Systolic Blood Pressure Intervention Trial

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Drug: Standard control of SBP; Drug: Intensive control of SBP

• Registration Number: NCT01206062
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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 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.

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Study Start: 2010-10
• Primary Completion: 2016-07
• Results First Submitted: 2017-07-13
• Results First Submitted QC: 2017-11-29
• Results First Posted: 2017-12-04
• Study Completion: 2019-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9361

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Control of SBP	Standard control of SBP	Participants randomized into the Standard arm will have a goal of SBP \<140 mm Hg. Intensify therapy if SBP ≥160 mm Hg @ 1 visit; ≥140 mm Hg @ 2 consecutive visits; Down-titration if SBP \<130 mm Hg @ 1 visit; \<135 mm Hg @ 2 consecutive visits
Intensive Control of SBP	Intensive control of SBP	Participants randomized into the Intensive BP arm will have a goal of SBP \<120 mm Hg. 2-drug therapy initiated in most Intensive participants; age ≥75 years and SBP 130-139 mm Hg on 0-1 drug; may begin with 1 drug, but add second at 1 month if SBP ≥130 mm Hg; drugs added and/or titrated at each visit (monthly) to achieve SBP \<120 mm Hg; at periodic "milepost" visits: addition of another drug "required" if not at goal.

Primary Outcome Measures

Name	Time	Method
Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death	6 years

Secondary Outcome Measures

Name	Time	Method
Number of Participants With All-cause Mortality	6 years
Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR	6 years
Participants Who Developed End Stage Renal Disease	6 years
Number of Patients With All-cause Dementia	6 years	A 3-step process was used ascertain incident cases of all-cause dementia. First, to identify possible cases of dementia a brief Cognition Screening Battery was administered to all participants. Participants who score below the pre-designated screening cut-point for possible cognitive impairment during follow-up were administered a more comprehensive and detailed neurocognitive test battery (the Extended Cognitive Assessment Battery) plus the Functional Assessment Questionnaire (FAQ) which assesses impairments in daily living skills as a result of cognitive impairments. Last, all the above available tests and questionnaire data were submitted to a centralized, web-based system for adjudication by a panel of dementia experts who assigned final study classifications of probable dementia (PD), mild cognitive impairment (MCI) or no impairment (NI).
Small Vessel Cerebral Ischemic Disease	4 years	Change over 4 years in total white matter lesion volume from baseline Change over 4 years in total brain volume from baseline; Because of the skewed distribution for WML volume, we first applied an inverse hyperbolic sine transformation (asinh), which is similar to a log transformation but can accommodate values of zero. Linear mixed models, including random effects for participant and MRI facility, were used to estimate the change in WML volume and TBV between the treatment groups, including time since randomization (in days) and intracranial volume as covariates. Because the inverse hyperbolic sine transformation is nonlinear, and given the context of a mixed-effects model, back-transformation to the original scale of cm3 is difficult

Trial Locations

Locations (1)

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States