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Trial record 1 of 1092 for:    Systolic Blood Pressure Intervention Trial
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Systolic Blood Pressure Intervention Trial (SPRINT)

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ClinicalTrials.gov Identifier: NCT01206062
Recruitment Status : Active, not recruiting
First Posted : September 21, 2010
Results First Posted : December 4, 2017
Last Update Posted : October 18, 2018
Sponsor:
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

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
Enrollment 9361
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive Control of SBP Standard Control of SBP
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 4678 4683
Completed 4678 4683
Not Completed 0 0
Arm/Group Title Intensive Control of SBP Standard Control of SBP Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 4678 4683 9361
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 4678 participants 4683 participants 9361 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 participants
Non-Hispanic black
1379
  29.5%
1423
  30.4%
2802
  29.9%
Hispanic
503
  10.8%
481
  10.3%
984
  10.5%
Non-Hispanic white
2698
  57.7%
2701
  57.7%
5399
  57.7%
Other
98
   2.1%
78
   1.7%
176
   1.9%
[1]
Measure Description: Race and ethnic group were self-reported.
Estimated GFR  
Mean (Standard Deviation)
Unit of measure:  Ml/min/1.73 m2
Number Analyzed 4678 participants 4683 participants 9361 participants
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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 participants
Age > 75 years
1317
  28.2%
1319
  28.2%
2636
  28.2%
Chronic kidney disease
1330
  28.4%
1316
  28.1%
2646
  28.3%
Cardiovascular disease
940
  20.1%
937
  20.0%
1877
  20.1%
Cardiovascular disease clinical
779
  16.7%
783
  16.7%
1562
  16.7%
Cardiovascular disease subclinical
247
   5.3%
246
   5.3%
493
   5.3%
Framingham CVD risk score >= 15%
2870
  61.4%
2867
  61.2%
5737
  61.3%
[1]
Measure Description:

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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 participants
1454
  31.1%
1493
  31.9%
2947
  31.5%
[1]
Measure Description: Black race includes Hispanic black and black as part of a multiracial identification.
Baseline BP mm Hg  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 4678 participants 4683 participants 9361 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 participants
< 132 mm Hg
1583
  33.8%
1553
  33.2%
3136
  33.5%
> 132 mm Hg to < 145 mm Hg
1489
  31.8%
1549
  33.1%
3038
  32.5%
> 145 mm Hg
1606
  34.3%
1581
  33.8%
3187
  34.0%
Serum creatinine  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 4678 participants 4683 participants 9361 participants
1.07  (0.34) 1.08  (0.34) 1.07  (0.34)
Ratio of urinary albumin (mg) to creatinine (g)  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 4678 participants 4683 participants 9361 participants
44.1  (178.7) 41.1  (152.9) 42.6  (166.3)
Fasting total cholesterol - mg/dl  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 4678 participants 4683 participants 9361 participants
190.2  (41.4) 190.0  (40.9) 190.1  (41.2)
Fasting HDL cholesterol - mg/dl  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 4678 participants 4683 participants 9361 participants
52.9  (14.3) 52.8  (14.6) 52.9  (14.5)
Fasting total triglycerides — mg/dl  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 4678 participants 4683 participants 9361 participants
124.8  (85.8) 127.1  (95.0) 125.9  (90.5)
Fasting plasma glucose — mg/dl  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 4678 participants 4683 participants 9361 participants
98.8  (13.7) 98.8  (13.4) 98.8  (13.5)
Statin use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 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. (%)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 participants
Never smoked
2050
  43.8%
2072
  44.2%
4122
  44.0%
Former smoker
1977
  42.3%
1996
  42.6%
3973
  42.4%
Current smoker
639
  13.7%
601
  12.8%
1240
  13.2%
Missing data
12
   0.3%
14
   0.3%
26
   0.3%
Framingham 10-yr cardiovascular disease risk score   [1] 
Mean (Standard Deviation)
Unit of measure:  Probability
Number Analyzed 4678 participants 4683 participants 9361 participants
24.8  (12.6) 24.8  (12.5) 24.8  (12.5)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 4678 participants 4683 participants 9361 participants
29.9  (5.8) 29.8  (5.7) 29.9  (5.8)
[1]
Measure Description: The body-mass index is the weight in kilograms divided by the square of the height in meters.
Antihypertensive agents — no./patient  
Mean (Standard Deviation)
Unit of measure:  Agents per patient
Number Analyzed 4678 participants 4683 participants 9361 participants
1.8  (1.0) 1.8  (1.0) 1.8  (1.0)
Not using antihypertensive agents — no. (%)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4678 participants 4683 participants 9361 participants
432
   9.2%
450
   9.6%
882
   9.4%
1.Primary Outcome
Title Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death
Hide Description [Not Specified]
Time Frame 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Control of SBP Standard Control of SBP
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 4678 4683
Measure Type: Count of Participants
Unit of Measure: Participants
243
   5.2%
319
   6.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Control of SBP, Standard Control of SBP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.64 to 0.89
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With All-cause Mortality
Hide Description [Not Specified]
Time Frame 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Control of SBP Standard Control of SBP
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 4678 4683
Measure Type: Count of Participants
Unit of Measure: Participants
155
   3.3%
210
   4.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Control of SBP, Standard Control of SBP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.60 to 0.90
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR
Hide Description [Not Specified]
Time Frame 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with CKD at baseline
Arm/Group Title Intensive Control of SBP Standard Control of SBP
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1330 1316
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.8%
12
   0.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Control of SBP, Standard Control of SBP
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.34 to 1.83
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Participants Who Developed End Stage Renal Disease
Hide Description [Not Specified]
Time Frame 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Control of SBP Standard Control of SBP
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 4678 4683
Measure Type: Count of Participants
Unit of Measure: Participants
12
   0.3%
8
   0.2%
5.Secondary Outcome
Title Dementia
Hide Description Additional data are being collected over the next year.
Time Frame 6 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Decline in Cognitive Function
Hide Description Additional data are being collected over the next year.
Time Frame 6 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Small Vessel Cerebral Ischemic Disease
Hide Description Additional data are being collected over the next year.
Time Frame 6 years
Outcome Measure Data Not Reported
Time Frame Includes Serious Adverse Events (SAEs) reported after randomization and throughout the duration of the trial, mean follow-up was 3.26 years.
Adverse Event Reporting Description Adverse event reporting included occurrence of acute kidney injury or acute renal failure and specific monitored conditions if they were evaluated in emergency departments (hypotension, syncope, injurious falls, electrolyte abnormalities, bradycardia).
 
Arm/Group Title Intensive Control of SBP Standard Control of SBP
Hide Arm/Group Description

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

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.

All-Cause Mortality
Intensive Control of SBP Standard Control of SBP
Affected / at Risk (%) Affected / at Risk (%)
Total   155/4678 (3.31%)   210/4683 (4.48%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Control of SBP Standard Control of SBP
Affected / at Risk (%) Affected / at Risk (%)
Total   1793/4678 (38.33%)   1736/4683 (37.07%) 
Cardiac disorders     
Chest Pain *  198/4678 (4.23%)  191/4683 (4.08%) 
Tachyarrhythmia *  141/4678 (3.01%)  176/4683 (3.76%) 
Other ischaemic heart disease *  170/4678 (3.63%)  182/4683 (3.89%) 
Cardiac failure *  58/4678 (1.24%)  98/4683 (2.09%) 
Myocardial infarcation *  70/4678 (1.50%)  106/4683 (2.26%) 
Hypertension *  58/4678 (1.24%)  69/4683 (1.47%) 
Cardiac pacemaker insertion *  33/4678 (0.71%)  39/4683 (0.83%) 
General disorders     
Death *  155/4678 (3.31%)  210/4683 (4.48%) 
Dehydration *  51/4678 (1.09%)  41/4683 (0.88%) 
Other * [1]  952/4678 (20.35%)  951/4683 (20.31%) 
Infections and infestations     
Cellulitis *  40/4678 (0.86%)  30/4683 (0.64%) 
Sepsis *  36/4678 (0.77%)  40/4683 (0.85%) 
Musculoskeletal and connective tissue disorders     
Knee arthroplasty *  138/4678 (2.95%)  119/4683 (2.54%) 
Hip arthroplasty *  67/4678 (1.43%)  81/4683 (1.73%) 
Spinal fusion surgery *  46/4678 (0.98%)  30/4683 (0.64%) 
Spinal laminectomy *  36/4678 (0.77%)  32/4683 (0.68%) 
Nervous system disorders     
Dizziness *  34/4678 (0.73%)  25/4683 (0.53%) 
Renal and urinary disorders     
Urinary tract infection *  48/4678 (1.03%)  47/4683 (1.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  100/4678 (2.14%)  114/4683 (2.43%) 
Chronic obstructive pulmonary disease *  42/4678 (0.90%)  64/4683 (1.37%) 
Dyspnoea *  48/4678 (1.03%)  45/4683 (0.96%) 
Vascular disorders     
Ischaemic cerebrovascular conditions *  109/4678 (2.33%)  121/4683 (2.58%) 
Pulmonary embolism *  34/4678 (0.73%)  32/4683 (0.68%) 
Pulmonary embolism *  32/4678 (0.68%)  31/4683 (0.66%) 
*
Indicates events were collected by non-systematic assessment
[1]
Occurred in less than 1% of total adverse events
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intensive Control of SBP Standard Control of SBP
Affected / at Risk (%) Affected / at Risk (%)
Total   1399/4678 (29.91%)   1342/4683 (28.66%) 
Cardiac disorders     
Hypotension *  48/4678 (1.03%)  27/4683 (0.58%) 
General disorders     
Electrolyte Abnormality *  33/4678 (0.71%)  22/4683 (0.47%) 
Injurious fall *  229/4678 (4.90%)  222/4683 (4.74%) 
Serum sodium < 130 mmol/liter *  180/4678 (3.85%)  100/4683 (2.14%) 
Serum sodium > 150 mmol/liter *  6/4678 (0.13%)  0/4683 (0.00%) 
Serum potassium <3.0 mmol/liter *  114/4678 (2.44%)  74/4683 (1.58%) 
Serum potassium >5.5 mmol/liter *  176/4678 (3.76%)  171/4683 (3.65%) 
Nervous system disorders     
Syncope *  56/4678 (1.20%)  33/4683 (0.70%) 
Orthostatic hypotension alone *  777/4678 (16.61%)  857/4683 (18.30%) 
Orthostatic hypotension with dizziness *  62/4678 (1.33%)  71/4683 (1.52%) 
Renal and urinary disorders     
Acute kidney injury or acute renal failure *  11/4678 (0.24%)  3/4683 (0.06%) 
Vascular disorders     
Bradycardia *  17/4678 (0.36%)  10/4683 (0.21%) 
*
Indicates events were collected by non-systematic assessment
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
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: October 18, 2018