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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William B. White, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01650402
First received: December 14, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Hypertension, Systolic
Cerebrovascular Disease
Drug: ACE inhibitor, calcium channel blocker
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Change from baseline in mobility parameters (self-paced walk and stance times) [ Time Frame: Baseline, after 18 months and end of study (36 months) ] [ Designated as safety issue: No ]
  • Change from baseline in cognitive function (executive function, processing speed) [ Time Frame: Baseline, after 18 months, and at the end of study (36 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650402

Contacts
Contact: Julia Schmidt 860-679-2705 jaschmidt@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Julia Schmidt    860-679-2705    jaschmidt@uchc.edu   
Contact: William B White, M.D.    860-679-2104      
Principal Investigator: William B White, M.D.         
Sponsors and Collaborators
University of Connecticut Health Center
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
  More Information

No publications provided by University of Connecticut Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William B. White, Professor, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01650402     History of Changes
Other Study ID Numbers: 11-155S-2, 2R01AG022092-06A1
Study First Received: December 14, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Connecticut Health Center:
Hypertension, systolic
Elderly (> or equal to 75 years)
Cerebrovascular disease

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

ClinicalTrials.gov processed this record on November 25, 2014