Trial Outcomes & Findings for Systolic Blood Pressure Intervention Trial (NCT NCT01206062)

NCT ID: NCT01206062

Last Updated: 2021-01-08

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

9361 participants

Primary outcome timeframe

6 years

Results posted on

2021-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	4678	4683
Overall Study COMPLETED	4678	4683
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Systolic Blood Pressure Intervention Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive Control of SBP n=4678 Participants 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 n=4683 Participants 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 n=9361 Participants Total of all reporting groups
Age, Continuous Age overall	67.9 year STANDARD_DEVIATION 9.4 • n=99 Participants	67.9 year STANDARD_DEVIATION 9.5 • n=107 Participants	67.9 year STANDARD_DEVIATION 9.4 • n=206 Participants
Sex: Female, Male Female	1684 Participants n=99 Participants	1648 Participants n=107 Participants	3332 Participants n=206 Participants
Sex: Female, Male Male	2994 Participants n=99 Participants	3035 Participants n=107 Participants	6029 Participants n=206 Participants
Race/Ethnicity, Customized Non-Hispanic black	1379 Participants n=99 Participants	1423 Participants n=107 Participants	2802 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic	503 Participants n=99 Participants	481 Participants n=107 Participants	984 Participants n=206 Participants
Race/Ethnicity, Customized Non-Hispanic white	2698 Participants n=99 Participants	2701 Participants n=107 Participants	5399 Participants n=206 Participants
Race/Ethnicity, Customized Other	98 Participants n=99 Participants	78 Participants n=107 Participants	176 Participants n=206 Participants
Estimated GFR Among all participants	71.8 ml/min/1.73 m2 STANDARD_DEVIATION 20.7 • n=99 Participants	71.7 ml/min/1.73 m2 STANDARD_DEVIATION 20.5 • n=107 Participants	71.7 ml/min/1.73 m2 STANDARD_DEVIATION 20.6 • n=206 Participants
Estimated GFR Among those with estimated GFR >= 60 ml/min/1.73 m	81.3 ml/min/1.73 m2 STANDARD_DEVIATION 15.5 • n=99 Participants	81.1 ml/min/1.73 m2 STANDARD_DEVIATION 15.5 • n=107 Participants	81.2 ml/min/1.73 m2 STANDARD_DEVIATION 15.5 • n=206 Participants
Estimated GFR Among those with estimated GFR < 60 ml/min/1.73 m	47.8 ml/min/1.73 m2 STANDARD_DEVIATION 9.5 • n=99 Participants	47.9 ml/min/1.73 m2 STANDARD_DEVIATION 9.5 • n=107 Participants	47.8 ml/min/1.73 m2 STANDARD_DEVIATION 9.5 • n=206 Participants
Criterion for increased cardiovascular risk Age > 75 years	1317 Participants n=99 Participants	1319 Participants n=107 Participants	2636 Participants n=206 Participants
Criterion for increased cardiovascular risk Chronic kidney disease	1330 Participants n=99 Participants	1316 Participants n=107 Participants	2646 Participants n=206 Participants
Criterion for increased cardiovascular risk Cardiovascular disease	940 Participants n=99 Participants	937 Participants n=107 Participants	1877 Participants n=206 Participants
Criterion for increased cardiovascular risk Cardiovascular disease clinical	779 Participants n=99 Participants	783 Participants n=107 Participants	1562 Participants n=206 Participants
Criterion for increased cardiovascular risk Cardiovascular disease subclinical	247 Participants n=99 Participants	246 Participants n=107 Participants	493 Participants n=206 Participants
Criterion for increased cardiovascular risk Framingham CVD risk score >= 15%	2870 Participants n=99 Participants	2867 Participants n=107 Participants	5737 Participants n=206 Participants
Black race	1454 Participants n=99 Participants	1493 Participants n=107 Participants	2947 Participants n=206 Participants
Baseline BP mm Hg Systolic	139.7 mm Hg STANDARD_DEVIATION 15.8 • n=99 Participants	139.7 mm Hg STANDARD_DEVIATION 15.4 • n=107 Participants	139.7 mm Hg STANDARD_DEVIATION 15.6 • n=206 Participants
Baseline BP mm Hg Diastolic	78.2 mm Hg STANDARD_DEVIATION 11.9 • n=99 Participants	78.0 mm Hg STANDARD_DEVIATION 12.0 • n=107 Participants	78.1 mm Hg STANDARD_DEVIATION 11.9 • n=206 Participants
Distribution of systolic blood pressure < 132 mm Hg	1583 Participants n=99 Participants	1553 Participants n=107 Participants	3136 Participants n=206 Participants
Distribution of systolic blood pressure > 132 mm Hg to < 145 mm Hg	1489 Participants n=99 Participants	1549 Participants n=107 Participants	3038 Participants n=206 Participants
Distribution of systolic blood pressure > 145 mm Hg	1606 Participants n=99 Participants	1581 Participants n=107 Participants	3187 Participants n=206 Participants
Serum creatinine	1.07 mg/dl STANDARD_DEVIATION 0.34 • n=99 Participants	1.08 mg/dl STANDARD_DEVIATION 0.34 • n=107 Participants	1.07 mg/dl STANDARD_DEVIATION 0.34 • n=206 Participants
Ratio of urinary albumin (mg) to creatinine (g)	44.1 ratio STANDARD_DEVIATION 178.7 • n=99 Participants	41.1 ratio STANDARD_DEVIATION 152.9 • n=107 Participants	42.6 ratio STANDARD_DEVIATION 166.3 • n=206 Participants
Fasting total cholesterol - mg/dl	190.2 mg/dl STANDARD_DEVIATION 41.4 • n=99 Participants	190.0 mg/dl STANDARD_DEVIATION 40.9 • n=107 Participants	190.1 mg/dl STANDARD_DEVIATION 41.2 • n=206 Participants
Fasting HDL cholesterol - mg/dl	52.9 mg/dl STANDARD_DEVIATION 14.3 • n=99 Participants	52.8 mg/dl STANDARD_DEVIATION 14.6 • n=107 Participants	52.9 mg/dl STANDARD_DEVIATION 14.5 • n=206 Participants
Fasting total triglycerides - mg/dl	124.8 mg/dl STANDARD_DEVIATION 85.8 • n=99 Participants	127.1 mg/dl STANDARD_DEVIATION 95.0 • n=107 Participants	125.9 mg/dl STANDARD_DEVIATION 90.5 • n=206 Participants
Fasting plasma glucose - mg/dl	98.8 mg/dl STANDARD_DEVIATION 13.7 • n=99 Participants	98.8 mg/dl STANDARD_DEVIATION 13.4 • n=107 Participants	98.8 mg/dl STANDARD_DEVIATION 13.5 • n=206 Participants
Statin use Statin Use	1978 Participants n=99 Participants	2076 Participants n=107 Participants	4054 Participants n=206 Participants
Statin use No Statin Use	2667 Participants n=99 Participants	2564 Participants n=107 Participants	5231 Participants n=206 Participants
Statin use Unknown Statin Use	33 Participants n=99 Participants	43 Participants n=107 Participants	76 Participants n=206 Participants
Aspirin use Aspirin Use	2406 Participants n=99 Participants	2350 Participants n=107 Participants	4756 Participants n=206 Participants
Aspirin use No Aspirin Use	2255 Participants n=99 Participants	2316 Participants n=107 Participants	4571 Participants n=206 Participants
Aspirin use Unknown Aspirin Use	17 Participants n=99 Participants	17 Participants n=107 Participants	34 Participants n=206 Participants
Smoking status - no. (%) Never smoked	2050 Participants n=99 Participants	2072 Participants n=107 Participants	4122 Participants n=206 Participants
Smoking status - no. (%) Former smoker	1977 Participants n=99 Participants	1996 Participants n=107 Participants	3973 Participants n=206 Participants
Smoking status - no. (%) Current smoker	639 Participants n=99 Participants	601 Participants n=107 Participants	1240 Participants n=206 Participants
Smoking status - no. (%) Missing data	12 Participants n=99 Participants	14 Participants n=107 Participants	26 Participants n=206 Participants
Framingham 10-yr cardiovascular disease risk score	24.8 probability STANDARD_DEVIATION 12.6 • n=99 Participants	24.8 probability STANDARD_DEVIATION 12.5 • n=107 Participants	24.8 probability STANDARD_DEVIATION 12.5 • n=206 Participants
Body-mass index	29.9 kg/m^2 STANDARD_DEVIATION 5.8 • n=99 Participants	29.8 kg/m^2 STANDARD_DEVIATION 5.7 • n=107 Participants	29.9 kg/m^2 STANDARD_DEVIATION 5.8 • n=206 Participants
Antihypertensive agents - no./patient	1.8 agents per patient STANDARD_DEVIATION 1.0 • n=99 Participants	1.8 agents per patient STANDARD_DEVIATION 1.0 • n=107 Participants	1.8 agents per patient STANDARD_DEVIATION 1.0 • n=206 Participants
Not using antihypertensive agents - no. (%)	432 Participants n=99 Participants	450 Participants n=107 Participants	882 Participants n=206 Participants

PRIMARY outcome

Timeframe: 6 years

Outcome measures

Outcome measures
Measure	Intensive Control of SBP n=4678 Participants 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 n=4683 Participants 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.
Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death	243 Participants	319 Participants

SECONDARY outcome

Timeframe: 6 years

Outcome measures

Outcome measures
Measure	Intensive Control of SBP n=4678 Participants 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 n=4683 Participants 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.
Number of Participants With All-cause Mortality	155 Participants	210 Participants

SECONDARY outcome

Timeframe: 6 years

Population: Participants with CKD at baseline

Outcome measures

Outcome measures
Measure	Intensive Control of SBP n=1330 Participants 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 n=1316 Participants 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.
Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR	10 Participants	12 Participants

SECONDARY outcome

Timeframe: 6 years

Outcome measures

Outcome measures
Measure	Intensive Control of SBP n=4678 Participants 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 n=4683 Participants 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.
Participants Who Developed End Stage Renal Disease	12 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 years

Population: Participants who completed at least 1 cognitive assessment during follow-up

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).

Outcome measures

Outcome measures
Measure	Intensive Control of SBP n=4278 Participants 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 n=4285 Participants 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.
Number of Patients With All-cause Dementia	149 Participants	176 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Of the 670 participants with WML volume measurement at baseline, 462 completed the follow-up MRI. Image quality control requirements were not met for 13 participants with a follow-up MRI scan, resulting in a sample of 449 adults.

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

Outcome measures

Outcome measures
Measure	Intensive Control of SBP n=200 Participants 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 n=249 Participants 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.
Small Vessel Cerebral Ischemic Disease Change in total white matter lesion volume from ba	0.23 asinh(cm3) Interval 0.17 to 0.29	0.37 asinh(cm3) Interval 0.3 to 0.43
Small Vessel Cerebral Ischemic Disease Change in total brain volume from baseline	-7.7 asinh(cm3) Interval -8.1 to -7.3	-6.8 asinh(cm3) Interval -7.3 to -6.3

Adverse Events

Intensive Control of SBP

Serious events: 1793 serious events

Other events: 1399 other events

Deaths: 155 deaths

Standard Control of SBP

Serious events: 1736 serious events

Other events: 1342 other events

Deaths: 210 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Intensive Control of SBP n=4678 participants at risk 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 n=4683 participants at risk 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.
Cardiac disorders Hypotension	1.0% 48/4678 • 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 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).	0.58% 27/4683 • 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 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).
Nervous system disorders Syncope	1.2% 56/4678 • 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 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).	0.70% 33/4683 • 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 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).
Vascular disorders Bradycardia	0.36% 17/4678 • 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 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).	0.21% 10/4683 • 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 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).
General disorders Electrolyte Abnormality	0.71% 33/4678 • 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 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).	0.47% 22/4683 • 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 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).
General disorders Injurious fall	4.9% 229/4678 • 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 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).	4.7% 222/4683 • 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 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).
Renal and urinary disorders Acute kidney injury or acute renal failure	0.24% 11/4678 • 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 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).	0.06% 3/4683 • 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 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).
General disorders Serum sodium < 130 mmol/liter	3.8% 180/4678 • 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 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).	2.1% 100/4683 • 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 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).
General disorders Serum sodium > 150 mmol/liter	0.13% 6/4678 • 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 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).	0.00% 0/4683 • 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 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).
General disorders Serum potassium <3.0 mmol/liter	2.4% 114/4678 • 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 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).	1.6% 74/4683 • 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 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).
General disorders Serum potassium >5.5 mmol/liter	3.8% 176/4678 • 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 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).	3.7% 171/4683 • 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 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).
Nervous system disorders Orthostatic hypotension alone	16.6% 777/4678 • 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 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).	18.3% 857/4683 • 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 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).
Nervous system disorders Orthostatic hypotension with dizziness	1.3% 62/4678 • 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 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).	1.5% 71/4683 • 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 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).

Additional Information

David Reboussin

Wake Forest University Health Sciences

Phone: 336-716-6844

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place