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

NCT01650402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2020-11-18

Study results available
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Summary

This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.

Conditions

  • Hypertension, Systolic
  • Cerebrovascular Disease

Interventions

OTHER

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

OTHER

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • UConn Health

    lead OTHER

Principal Investigators

  • William B. White, M.D. · Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center

  • Leslie Wolfson, M.D. · Department of Neurology, University of Connecticut Health Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01650402 on ClinicalTrials.gov