Systolic Blood Pressure Intervention Trial (SPRINT)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension |
Other: Intensive control of SBP Other: Standard BP arm |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Systolic Blood Pressure Intervention Trial |
- First occurrence of a myocardial infarction (MI), acute coronary syndrome (ACS), stroke, heart failure (HF), or CVD death [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Decline in renal function [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Development of end stage renal disease (ESRD), [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Dementia [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Decline in cognitive function [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Small vessel cerebral ischemic disease [ Time Frame: 6 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 9250 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | October 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intensive BP Arm
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.
|
Other: Intensive control of SBP
Participants in the Intensive arm have a goal of SBP <120 mm Hg. Use of once-daily antihypertensive agents will be encouraged unless alternative frequency is indicated/necessary. One or more medications from the following classes of agents will be provided by the study for use in managing participants in both randomization groups to achieve study goals: Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics Combination products will be available, depending on cost, utility, or donations from pharmaceutical companies. Other Names:
|
|
Active Comparator: Standard BP Arm
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
|
Other: Standard BP arm
Participants in the Standard BP arm have a goal of SBP <140 mm Hg. The same medications used in the Intensive BP arm will be used for the Standard BP arm.
Other Name: Control of SBP to a target of 140 mm Hg
|
Detailed Description:
SPRINT will randomize about 9250 participants aged ≥ 50 years with SBP ≥130 mm Hg and at least one additional CVD risk factor. The trial will compare 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 are <120 vs <140 mm Hg, respectively, to create a minimum mean difference of 10 mm Hg between the two randomized groups. The primary hypothesis is that CVD event rates will be lower in the intensive arm. Participants will be recruited at approximately 90 clinics within 5 clinical center networks (CCNs) over approximately a 2-year period, and will be followed for 4-6 years.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
- 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 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.
Contacts and Locations| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | David M. Reboussin, PhD | Wake Forest University |
| Principal Investigator: | Jackson T Wright, MD | Case Western Reserve University |
| Principal Investigator: | Alfred Cheung, MD | University of Utah |
| Principal Investigator: | Suzanne Oparil, MD | University of Alabama at Birmingham |
| Principal Investigator: | Mike Rocco, MD | Wake Forest University |
| Principal Investigator: | Bill Cushman, MD | Memphis VA Medical Center |
More Information
No publications provided
| Responsible Party: | David Reboussin, Principal Investigator, Wake Forest University Baptist Medical Center |
| ClinicalTrials.gov Identifier: | NCT01206062 History of Changes |
| Other Study ID Numbers: | 704, R01HL107257-01A1 |
| Study First Received: | September 20, 2010 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest University Baptist Medical Center:
|
blood pressure antihypertensive systolic diastolic heart failure |
myocardial infarction stroke chronic kidney disease dementia cognitive decline |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013