- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01650402
Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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
|
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
|
Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobility - Measured by Change in Gait Speed
Time Frame: 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).
|
Change from baseline to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Function - as Measured by Change in Stroop Test Score
Time Frame: 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. |
Change from baseline to 36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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 and helpful links
General Publications
- Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.
- Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.
- White WB, Wakefield DB, Moscufo N, Guttmann CRG, Kaplan RF, Bohannon RW, Fellows D, Hall CB, Wolfson L. Effects of Intensive Versus Standard Ambulatory Blood Pressure Control on Cerebrovascular Outcomes in Older People (INFINITY). Circulation. 2019 Nov 12;140(20):1626-1635. doi: 10.1161/CIRCULATIONAHA.119.041603. Epub 2019 Oct 14.
- White WB, Jalil F, Wakefield DB, Kaplan RF, Bohannon RW, Hall CB, Moscufo N, Fellows D, Guttmann CRG, Wolfson L. Relationships among clinic, home, and ambulatory blood pressures with small vessel disease of the brain and functional status in older people with hypertension. Am Heart J. 2018 Nov;205:21-30. doi: 10.1016/j.ahj.2018.08.002. Epub 2018 Aug 11.
- White WB, Marfatia R, Schmidt J, Wakefield DB, Kaplan RF, Bohannon RW, Hall CB, Guttmann CR, Moscufo N, Fellows D, Wolfson L. INtensive versus standard ambulatory blood pressure lowering to prevent functional DeclINe in the ElderlY (INFINITY). Am Heart J. 2013 Mar;165(3):258-265.e1. doi: 10.1016/j.ahj.2012.11.008. Epub 2013 Jan 5.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-155S-2
- 2R01AG022092-06A1 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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