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Systolic Blood Pressure Intervention Trial (SPRINT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206062
First Posted: September 21, 2010
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Aging (NIA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Neurological Disorders and Stroke (NINDS)
Wake Forest University Health Sciences
Information provided by (Responsible Party):
David Reboussin, Wake Forest University Health Sciences
Results First Submitted: July 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Intensive control of SBP
Drug: Standard control of SBP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intensive Control of SBP

Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most 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 visits: addition of another drug "required" if not at goal.

Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both 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

Standard Control of SBP

Participants randomized into the Standard arm had 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

Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm.


Participant Flow:   Overall Study
    Intensive Control of SBP   Standard Control of SBP
STARTED   4678   4683 
COMPLETED   4678   4683 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intensive Control of SBP

Participants randomized into the Intensive BP arm had a goal of SBP <120 mm Hg. 2-drug therapy initiated in most 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 visits: addition of another drug "required" if not at goal.

Intensive control of SBP: Use of once-daily antihypertensive agents was encouraged unless alternative frequency was necessary. One or more medications from the following classes of agents were provided by the study for use in managing participants in both 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

Standard Control of SBP

Participants randomized into the Standard arm had 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

Standard control of SBP: The same medications used in the Intensive BP arm will be used for the Standard BP arm.

Total Total of all reporting groups

Baseline Measures
   Intensive Control of SBP   Standard Control of SBP   Total 
Overall Participants Analyzed 
[Units: Participants]
 4678   4683   9361 
Age 
[Units: Year]
Mean (Standard Deviation)
     
Age overall   67.9  (9.4)   67.9  (9.5)   67.9  (9.4) 
Among those >= 75   79.8  (3.9)   79.9  (4.1)   79.9  (4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1684  36.0%      1648  35.2%      3332  35.6% 
Male      2994  64.0%      3035  64.8%      6029  64.4% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
     
Non-Hispanic black   1379   1423   2802 
Hispanic   503   481   984 
Non-Hispanic white   2698   2701   5399 
Other   98   78   176 
[1] Race and ethnic group were self-reported.
Estimated GFR 
[Units: Ml/min/1.73 m2]
Mean (Standard Deviation)
     
Among all participants   71.8  (20.7)   71.7  (20.5)   71.7  (20.6) 
Among those with estimated GFR >= 60 ml/min/1.73 m   81.3  (15.5)   81.1  (15.5)   81.2  (15.5) 
Among those with estimated GFR < 60 ml/min/1.73 m   47.8  (9.5)   47.9  (9.5)   47.8  (9.5) 
Criterion for increased cardiovascular risk [1] 
[Units: Participants]
Count of Participants
     
Age > 75 years   1317   1319   2636 
Chronic kidney disease   1330   1316   2646 
Cardiovascular disease   940   937   1877 
Cardiovascular disease clinical   779   783   1562 
Cardiovascular disease subclinical   247   246   493 
Framingham CVD risk score >= 15%   2870   2867   5737 
[1]

Increased cardiovascular risk was one of the inclusion criteria.

Chronic kidney disease was defined as an estimated glomerular filtration rate of less than 60 ml per minute per 1.73 m squared of body-surface area.

Black race [1] 
[Units: Participants]
Count of Participants
 1454   1493   2947 
[1] Black race includes Hispanic black and black as part of a multiracial identification.
Baseline BP mm Hg 
[Units: Mm Hg]
Mean (Standard Deviation)
     
Systolic   139.7  (15.8)   139.7  (15.4)   139.7  (15.6) 
Diastolic   78.2  (11.9)   78.0  (12.0)   78.1  (11.9) 
Distribution of systolic blood pressure 
[Units: Participants]
Count of Participants
     
< 132 mm Hg   1583   1553   3136 
> 132 mm Hg to < 145 mm Hg   1489   1549   3038 
> 145 mm Hg   1606   1581   3187 
Serum creatinine 
[Units: Mg/dl]
Mean (Standard Deviation)
 1.07  (0.34)   1.08  (0.34)   1.07  (0.34) 
Ratio of urinary albumin (mg) to creatinine (g) 
[Units: Ratio]
Mean (Standard Deviation)
 44.1  (178.7)   41.1  (152.9)   42.6  (166.3) 
Fasting total cholesterol - mg/dl 
[Units: Mg/dl]
Mean (Standard Deviation)
 190.2  (41.4)   190.0  (40.9)   190.1  (41.2) 
Fasting HDL cholesterol - mg/dl 
[Units: Mg/dl]
Mean (Standard Deviation)
 52.9  (14.3)   52.8  (14.6)   52.9  (14.5) 
Fasting total triglycerides — mg/dl 
[Units: Mg/dl]
Mean (Standard Deviation)
 124.8  (85.8)   127.1  (95.0)   125.9  (90.5) 
Fasting plasma glucose — mg/dl 
[Units: Mg/dl]
Mean (Standard Deviation)
 98.8  (13.7)   98.8  (13.4)   98.8  (13.5) 
Statin use 
[Units: Participants]
Count of Participants
     
Statin Use      1978  42.3%      2076  44.3%      4054  43.3% 
No Statin Use      2667  57.0%      2564  54.8%      5231  55.9% 
Unknown Statin Use      33   0.7%      43   0.9%      76   0.8% 
Aspirin use 
[Units: Participants]
Count of Participants
     
Aspirin Use      2406  51.4%      2350  50.2%      4756  50.8% 
No Aspirin Use      2255  48.2%      2316  49.5%      4571  48.8% 
Unknown Aspirin Use      17   0.4%      17   0.4%      34   0.4% 
Smoking status — no. (%) 
[Units: Participants]
Count of Participants
     
Never smoked   2050   2072   4122 
Former smoker   1977   1996   3973 
Current smoker   639   601   1240 
Missing data   12   14   26 
Framingham 10-yr cardiovascular disease risk score [1] 
[Units: Probability]
Mean (Standard Deviation)
 24.8  (12.6)   24.8  (12.5)   24.8  (12.5) 
[1] The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. It presents risk as the probability of developing coronary heart disease (CHD) within the next 10 years. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Body-mass index [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.9  (5.8)   29.8  (5.7)   29.9  (5.8) 
[1] The body-mass index is the weight in kilograms divided by the square of the height in meters.
Antihypertensive agents — no./patient 
[Units: Agents per patient]
Mean (Standard Deviation)
 1.8  (1.0)   1.8  (1.0)   1.8  (1.0) 
Not using antihypertensive agents — no. (%) 
[Units: Participants]
Count of Participants
 432   450   882 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death   [ Time Frame: 6 years ]

2.  Secondary:   Number of Participants With All-cause Mortality   [ Time Frame: 6 years ]

3.  Secondary:   Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR   [ Time Frame: 6 years ]

4.  Secondary:   Participants Who Developed End Stage Renal Disease   [ Time Frame: 6 years ]

5.  Secondary:   Dementia   [ Time Frame: 6 years ]
Results not yet reported.   Anticipated Reporting Date:   05/2018  

6.  Secondary:   Decline in Cognitive Function   [ Time Frame: 6 years ]
Results not yet reported.   Anticipated Reporting Date:   05/2018  

7.  Secondary:   Small Vessel Cerebral Ischemic Disease   [ Time Frame: 6 years ]
Results not yet reported.   Anticipated Reporting Date:   05/2018  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Reboussin
Organization: Wake Forest University Health Sciences
phone: 336-716-6844
e-mail: drebouss@wakehealth.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: David Reboussin, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01206062     History of Changes
Other Study ID Numbers: SPRINT
268200900040C-1-0-1 ( U.S. NIH Grant/Contract )
First Submitted: September 20, 2010
First Posted: September 21, 2010
Results First Submitted: July 13, 2017
Results First Posted: December 4, 2017
Last Update Posted: December 4, 2017