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

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ClinicalTrials.gov Identifier: NCT01650402
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
William B. White, UConn Health

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension, Systolic Cerebrovascular Disease Other: Anti-hypertensive therapy to SBP 130 mm Hg Other: Anti-hypertensive therapy to SBP 145 mm Hg Not Applicable

Detailed Description:
The study patients will be enrolled and randomized to one of two levels of ambulatory BP control (intensive to achieve a goal 24-hour systolic BP of < 130 mmHg or standard to achieve a goal 24-hour systolic BP of < 145 mmHg) for a total of 36 months. Similar antihypertensive regimens will be used in both of the treatment groups. Titration of antihypertensive therapies will be performed at monthly intervals for the first 3 to 6 months post-randomization to achieve goal systolic BP. The primary and secondary outcomes will be evaluated at baseline, and following 18 months and 36 months of therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Study Start Date : December 2011
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive
Intensive anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 130 mmHg
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

Active Comparator: Standard
Standard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg
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




Primary Outcome Measures :
  1. Mobility [ Time Frame: Baseline, 18 months, and 36 months ]
    Change in gait speed in meters/second 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).


Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: Baseline, 18 months, and 36 months ]
    Change in cognitive function in stroop test



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 75 years of age or older
  • Seated clinic systolic BP >150 mmHg in the untreated state (see criterion D)
  • At risk for cerebrovascular disease (history of smoking, dyslipidemia, type 2 diabetes, longstanding hypertension, family history). Patients must have visible (0.5% WMH or more)white-matter hypertensity lesions on screening magnetic resonance imaging
  • To achieve success in maintaining a 24-hour systolic BP of <140-145 mmHg in the standard treatment group or a systolic BP <125-130 mmHg in the intensive treatment group, patients will be eligible for inclusion if (1) their clinic systolic BP is 150-170 mmHg, and they are taking 0 to 2 antihypertensives, (2) their systolic BP is >170 mmHg and they are taking 0 to 1 antihypertensives

Exclusion Criteria:

  • Uncontrolled diabetes mellitus (HBA1c >10%)
  • History of stroke, dementia or clinically impaired gait (Mini-mental status exam score (MMSE) <24, Short Physical Performance Battery for gait (SPPB) < 9,)
  • Body Mass Index > 45 kg/m2 and/or arm circumference > 44 cm)
  • Poor kidney function (defined as estimated GFR <30 ml/minute)
  • Active liver disease or serum transaminases >3 times the upper limit of normal
  • Major cardiovascular event (e.g. myocardial infarction) or procedure (e.g. cardiac bypass surgery) in past 3 months; stroke with residual gait abnormality
  • Uncompensated congestive heart failure (NYHA class III or IV or documented ejection fraction <30%)
  • Chronic atrial fibrillation that disallows ambulatory BP monitoring to be successfully performed
  • Medical conditions that limit survival to < 3 years
  • Non-dermatologic cancer diagnosed within 2 years
  • Organ transplantation requiring anti-rejection drug therapy
  • Severe and unexplained weight loss (>15%) in past 6 months
  • Medical need to undergo recurrent phlebotomy or blood transfusions
  • Current participation in another investigational trial
  • Unable to obtain informed consent
  • Factors limiting adherence to the interventions
  • MRI contraindications (including MRI-incompatible implants, severe claustrophobia).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650402


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Aging (NIA)
Investigators
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Principal Investigator: William B. White, M.D. Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center
Principal Investigator: Leslie Wolfson, M.D. Department of Neurology, University of Connecticut Health Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: William B. White, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT01650402     History of Changes
Other Study ID Numbers: 11-155S-2
2R01AG022092-06A1 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by William B. White, UConn Health:
Hypertension, systolic
Elderly (> or equal to 75 years)
Cerebrovascular disease

Additional relevant MeSH terms:
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Cerebrovascular Disorders
Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antihypertensive Agents