Trial Outcomes & Findings for Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People (NCT NCT01650402)
NCT ID: NCT01650402
Last Updated: 2020-11-18
Results Overview
Change in gait speed (walking 8 meters) in seconds mediated by the accrual of white-matter hyperintensity lesions (WMH/intracranial cavity volume) using MRI and including degeneration of axonal and myelin components of white matter using MRI technology known as diffusion tensor imaging (DTI).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
199 participants
Primary outcome timeframe
Change from baseline to 36 months
Results posted on
2020-11-18
Participant Flow
Participant milestones
| Measure |
Intensive
Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg
Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
|
Standard
Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg
Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
100
|
|
Overall Study
COMPLETED
|
79
|
86
|
|
Overall Study
NOT COMPLETED
|
20
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Baseline characteristics by cohort
| Measure |
Intensive
n=99 Participants
Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg
Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
|
Standard
n=100 Participants
Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg
Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
99 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 36 monthsPopulation: 78 participants from the intensive group and 86 participants from the standard group were included in the mobility analysis because 1 participant from the intensive group did not complete mobility testing
Change in gait speed (walking 8 meters) in seconds mediated by the accrual of white-matter hyperintensity lesions (WMH/intracranial cavity volume) using MRI and including degeneration of axonal and myelin components of white matter using MRI technology known as diffusion tensor imaging (DTI).
Outcome measures
| Measure |
Intensive
n=78 Participants
Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg
Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
|
Standard
n=86 Participants
Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg
Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg
|
|---|---|---|
|
Mobility - Measured by Change in Gait Speed
|
0.4 seconds
Standard Deviation 2.0
|
0.42 seconds
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Change from baseline to 36 monthsPopulation: 69 participants from the intensive group and 76 participants from the standard group were included in analysis because 10 participants in the intensive group and 10 participants in the standard group did not complete cognitive testing
Change in cognitive function as measured by stroop test score: number of correct responses in 45 seconds. The score for the Stroop Test is the number of correct responses provided in 45 seconds on each test condition: word reading, color naming, and inhibition. For the inhibition condition, words are written in an incongruous ink color (e.g., the word red written in blue ink) and participants must provide the ink color. Scores range from 0 to no upper limit, with higher scores indicating better performance.
Outcome measures
| Measure |
Intensive
n=69 Participants
Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg
Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
|
Standard
n=76 Participants
Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg
Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg
|
|---|---|---|
|
Cognitive Function - as Measured by Change in Stroop Test Score
|
-2.7 correct responses
Standard Deviation 8.0
|
-0.8 correct responses
Standard Deviation 6.4
|
Adverse Events
Intensive
Serious events: 33 serious events
Other events: 86 other events
Deaths: 2 deaths
Standard
Serious events: 36 serious events
Other events: 70 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Intensive
n=99 participants at risk
Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg
Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
|
Standard
n=100 participants at risk
Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg
Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
3.0%
3/99 • Number of events 3 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
4.0%
4/100 • Number of events 4 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Cardiac disorders
Heart failure
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Cardiac disorders
Stroke
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
4.0%
4/100 • Number of events 4 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Cardiac disorders
Pacemaker implantation
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Cardiac disorders
Presyncope
|
3.0%
3/99 • Number of events 4 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Cardiac disorders
Heart stent placement
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Cardiac disorders
Other cardiac hospitalizations
|
1.0%
1/99 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Endocrine disorders
Hyperglycemia hospitalization
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Gastrointestinal disorders
Bowel obstruction
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 5 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
2.0%
2/99 • Number of events 3 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Gastrointestinal disorders
Cholecystectomy
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Nervous system disorders
Aphasia
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Nervous system disorders
Vertigo
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Reproductive system and breast disorders
Breast cancer diagnosis
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 8 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Vascular disorders
Pulmonary Emboli
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
3/99 • Number of events 3 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
General disorders
Hospitalization for fall
|
3.0%
3/99 • Number of events 3 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Gastrointestinal disorders
Colon cancer diagnosis
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Endocrine disorders
Pancreatic cancer diagnosis
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Renal and urinary disorders
Urinary tract infection
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Infections and infestations
Influenza
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Infections and infestations
Bronchitis
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Infections and infestations
Pneumonia
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
2.0%
2/100 • Number of events 3 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Hip surgery
|
3.0%
3/99 • Number of events 3 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
4.0%
4/100 • Number of events 5 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Knee surgery
|
4.0%
4/99 • Number of events 5 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Vascular disorders
Subdural hematoma
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
General disorders
Hospitalization for pain
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
General disorders
Hospitalization for fatigue
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
General disorders
Hospitalization for weakness
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Abdominoplasty
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Hernia repair
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Ovarian mass removal
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Back surgery
|
2.0%
2/99 • Number of events 2 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
0/99 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Thyroid surgery
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Surgical and medical procedures
Pump placed for incontinence
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
0.00%
0/100 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
General disorders
Death due to cancer
|
1.0%
1/99 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
Other adverse events
| Measure |
Intensive
n=99 participants at risk
Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg
Anti-hypertensive therapy to SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
|
Standard
n=100 participants at risk
Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg
Anti-hypertensive therapy to SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg
|
|---|---|---|
|
General disorders
Fatigue
|
5.1%
5/99 • Number of events 5 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
5.0%
5/100 • Number of events 6 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
General disorders
Fall
|
30.3%
30/99 • Number of events 40 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
31.0%
31/100 • Number of events 44 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Vascular disorders
Edema
|
22.2%
22/99 • Number of events 22 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
13.0%
13/100 • Number of events 15 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
8.1%
8/99 • Number of events 10 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
9.0%
9/100 • Number of events 12 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Nervous system disorders
Dizziness
|
9.1%
9/99 • Number of events 11 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
6.0%
6/100 • Number of events 7 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
|
Nervous system disorders
Lightheadedness
|
12.1%
12/99 • Number of events 16 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
6.0%
6/100 • Number of events 8 • Adverse event data were collected throughout a participant's study completion, an average of 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place