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

NCT01650402 | Completed Results DMC

• 2 other identifiers: 11-155S-22R01AG022092-06A1
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Systolic; Cerebrovascular Disease

Keywords

Hypertension, systolic; Elderly (> or equal to 75 years); Cerebrovascular disease

Outcome Measures

Primary Outcomes (1)

• Mobility - Measured by Change in Gait Speed

  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 Outcomes (1)

• Cognitive Function - as Measured by Change in Stroop Test Score

  Change from baseline to 36 months

Study Arms (2)

Intensive

EXPERIMENTAL

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

Standard

ACTIVE COMPARATOR

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

Interventions

Anti-hypertensive therapy to SBP 130 mm Hg OTHER

Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg

Intensive

Anti-hypertensive therapy to SBP 145 mm Hg OTHER

Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg

Standard

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (5)

• 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.

  PMID: 36398903 DERIVED

• 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.

  PMID: 32905623 DERIVED

• 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.

  PMID: 31607143 DERIVED

• 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.

  PMID: 30145340 DERIVED

• 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.

  PMID: 23453090 DERIVED

MeSH Terms

Conditions

Isolated Systolic Hypertension; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Essential Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: William White, MD
• Organization: UConn Health

wwhite@uchc.edu

860-679-4556

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: July 26, 2012
• Study Start: December 1, 2011
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 18, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10

Locations

US (1)