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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 : Active, not recruiting
First Posted : July 26, 2012
Last Update Posted : December 15, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate different treatment strategies for high blood pressure using medications approved by the US Food and Drug Administration (FDA) for the treatment of high blood pressure. The study will compare the effects of an intensive reduction of 24-hour average blood pressure to a standard reduction of 24-hour mean blood pressure on controlling declines in mobility (speed and agility of walking) and cognition (ability to think and process information) in an aging population.

Condition or disease Intervention/treatment Phase
Hypertension, Systolic Cerebrovascular Disease Drug: ACE inhibitor, calcium channel blocker Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Study Start Date : December 2011
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Intensive
Multiple antihypertensive therapies to achieve 24H SBP less than or equal to 130 mm Hg
Drug: ACE inhibitor, calcium channel blocker
Daily, doses range depending on subject's response
Active Comparator: Standard
Single or multiple antihypertensive therapy to achieve 24H SBP less than or equal to 145 mm Hg
Drug: ACE inhibitor, calcium channel blocker
Daily, doses range depending on subject's response

Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in mobility parameters (self-paced walk and stance times) [ Time Frame: Baseline, after 18 months and end of study (36 months) ]
  2. Change from baseline in cognitive function (executive function, processing speed) [ Time Frame: Baseline, after 18 months, and at the end of study (36 months) ]

Secondary Outcome Measures :
  1. Accrual of white-matter hyperintensity (WMH) over the course of the trial (36 months) including degeneration of tissue and tissue perfusion using an MRI technology known as diffusion tensor imaging (DTI) [ Time Frame: Baseline, 18 and 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

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

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).
Contacts and Locations

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

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Aging (NIA)
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: December 15, 2016
Last Verified: December 2016

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

Additional relevant MeSH terms:
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Angiotensin-Converting Enzyme Inhibitors
Calcium Channel Blockers
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Membrane Transport Modulators