Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People

NCT01650402, Not applicable, Completed, UConn Health; results first posted 2020-10-30

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People	ClinicalTrials.gov
NCT number	NCT01650402	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	199 participants, actual	ClinicalTrials.gov
Lead sponsor	UConn Health	ClinicalTrials.gov
Conditions	Hypertension, Systolic, Cerebrovascular Disease	ClinicalTrials.gov
Interventions	Anti-hypertensive therapy to SBP 130 mm Hg, Anti-hypertensive therapy to SBP 145 mm Hg	ClinicalTrials.gov
First posted	2012-07-26	ClinicalTrials.gov
Last updated	2020-11-18	ClinicalTrials.gov
Results first posted	2020-10-30	ClinicalTrials.gov

Registered outcomes 2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Mobility - Measured by Change in Gait Speed	Change from baseline to 36 months	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).	ClinicalTrials.gov
Secondary	Cognitive Function - as Measured by Change in Stroop Test Score	Change from baseline to 36 months	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.	ClinicalTrials.gov

Outcomes 2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Mobility - Measured by Change in Gait Speed	Change from baseline to 36 months	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	seconds	MEAN	ClinicalTrials.gov
SECONDARY	Cognitive Function - as Measured by Change in Stroop Test Score	Change from baseline to 36 months	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	correct responses	MEAN	ClinicalTrials.gov

Results by group 4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units	Source
Mobility - Measured by Change in Gait Speed	Intensive	0.4	Standard Deviation 2.0	seconds	ClinicalTrials.gov
Mobility - Measured by Change in Gait Speed	Standard	0.42	Standard Deviation 2.73	seconds	ClinicalTrials.gov
Cognitive Function - as Measured by Change in Stroop Test Score	Intensive	-2.7	Standard Deviation 8.0	correct responses	ClinicalTrials.gov
Cognitive Function - as Measured by Change in Stroop Test Score	Standard	-0.8	Standard Deviation 6.4	correct responses	ClinicalTrials.gov

Participant flow 6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Intensive	99	ClinicalTrials.gov
Overall Study	STARTED	Standard	100	ClinicalTrials.gov
Overall Study	COMPLETED	Intensive	79	ClinicalTrials.gov
Overall Study	COMPLETED	Standard	86	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Intensive	20	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Standard	14	ClinicalTrials.gov

Adverse events 100

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source
other	Fatigue	General disorders	Intensive	5	99	5	ClinicalTrials.gov
other	Fatigue	General disorders	Standard	5	100	6	ClinicalTrials.gov
other	Fall	General disorders	Intensive	30	99	40	ClinicalTrials.gov
other	Fall	General disorders	Standard	31	100	44	ClinicalTrials.gov
other	Edema	Vascular disorders	Intensive	22	99	22	ClinicalTrials.gov
other	Edema	Vascular disorders	Standard	13	100	15	ClinicalTrials.gov
other	Urinary Tract Infection	Renal and urinary disorders	Intensive	8	99	10	ClinicalTrials.gov
other	Urinary Tract Infection	Renal and urinary disorders	Standard	9	100	12	ClinicalTrials.gov
other	Dizziness	Nervous system disorders	Intensive	9	99	11	ClinicalTrials.gov
other	Dizziness	Nervous system disorders	Standard	6	100	7	ClinicalTrials.gov
other	Lightheadedness	Nervous system disorders	Intensive	12	99	16	ClinicalTrials.gov
other	Lightheadedness	Nervous system disorders	Standard	6	100	8	ClinicalTrials.gov
serious	Arrhythmia	Cardiac disorders	Intensive	3	99	3	ClinicalTrials.gov
serious	Arrhythmia	Cardiac disorders	Standard	4	100	4	ClinicalTrials.gov
serious	Heart failure	Cardiac disorders	Intensive	0	99	0	ClinicalTrials.gov
serious	Heart failure	Cardiac disorders	Standard	2	100	2	ClinicalTrials.gov
serious	Stroke	Cardiac disorders	Intensive	2	99	2	ClinicalTrials.gov
serious	Stroke	Cardiac disorders	Standard	2	100	2	ClinicalTrials.gov
serious	Myocardial infarction	Cardiac disorders	Intensive	0	99	0	ClinicalTrials.gov
serious	Myocardial infarction	Cardiac disorders	Standard	4	100	4	ClinicalTrials.gov

Adverse event totals 6

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Intensive	2	99	ClinicalTrials.gov
Total, all-cause mortality	Standard	4	100	ClinicalTrials.gov
Total, other adverse events	Intensive	86	99	ClinicalTrials.gov
Total, other adverse events	Standard	70	100	ClinicalTrials.gov
Total, serious adverse events	Intensive	33	99	ClinicalTrials.gov
Total, serious adverse events	Standard	36	100	ClinicalTrials.gov

Papers 5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23453090	DERIVED	PubMed
30145340	DERIVED	PubMed
31607143	DERIVED	PubMed
32905623	DERIVED	PubMed
36398903	DERIVED	PubMed

Grants 1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R01AG022092	Intensive Blood Pressure Reduction to Lessen Functional Decline	WOLFSON, LESLIE; WHITE, WILLIAM BARRY	UNIVERSITY OF CONNECTICUT SCH OF MED/DNT	NATIONAL INSTITUTE ON AGING	2004 to 2017	NIH RePORTER

Trial comparisons 2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intensive vs Standard: deaths from any cause	Trial comparisons
Intensive vs Standard: serious adverse events	Trial comparisons

Tests 1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Stroop Color-Word Test	Secondary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)