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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01AG022092-06A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function - as Measured by Change in Stroop Test Score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5. | |
| 32905623 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg |
| FG001 | 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 SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 78 participants from the intensive group and 86 participants from the standard group were included in the mobility analysis because 1 participant from the intensive group did not complete mobility testing | Posted | Mean | Standard Deviation | seconds | Change from baseline to 36 months |
|
Adverse event data were collected throughout a participant's study completion, an average of 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 SBP 130 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William White, MD | UConn Health | 860-679-4556 | wwhite@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2018 | Oct 7, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 16, 2018 | Oct 7, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000092244 | Isolated Systolic Hypertension |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
|
| Change from baseline to 36 months |
| 31607143 | 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. |
| 30145340 | 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. |
| 23453090 | 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. |
| 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 SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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 SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg |
|
|
| Secondary | Cognitive Function - as Measured by Change in Stroop Test Score | 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. | 69 participants from the intensive group and 76 participants from the standard group were included in analysis because 10 participants in the intensive group and 10 participants in the standard group did not complete cognitive testing | Posted | Mean | Standard Deviation | correct responses | Change from baseline to 36 months |
|
|
|
| 2 |
| 99 |
| 33 |
| 99 |
| 86 |
| 99 |
| EG001 | 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 SBP 145 mm Hg: Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg | 4 | 100 | 36 | 100 | 70 | 100 |
| Heart failure | Cardiac disorders | Systematic Assessment |
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| Stroke | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Pacemaker implantation | Cardiac disorders | Systematic Assessment |
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| Presyncope | Cardiac disorders | Systematic Assessment |
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| Heart stent placement | Cardiac disorders | Systematic Assessment |
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| Other cardiac hospitalizations | Cardiac disorders | Systematic Assessment |
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| Hyperglycemia hospitalization | Endocrine disorders | Systematic Assessment |
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| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
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| Cholecystectomy | Gastrointestinal disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Aphasia | Nervous system disorders | Systematic Assessment |
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| Vertigo | Nervous system disorders | Systematic Assessment |
|
| Breast cancer diagnosis | Reproductive system and breast disorders | Systematic Assessment |
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| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Emboli | Vascular disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hospitalization for fall | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Colon cancer diagnosis | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatic cancer diagnosis | Endocrine disorders | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Hip surgery | Surgical and medical procedures | Systematic Assessment |
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| Knee surgery | Surgical and medical procedures | Systematic Assessment |
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| Subdural hematoma | Vascular disorders | Systematic Assessment |
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| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hospitalization for pain | General disorders | Systematic Assessment |
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| Hospitalization for fatigue | General disorders | Systematic Assessment |
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| Hospitalization for weakness | General disorders | Systematic Assessment |
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| Abdominoplasty | Surgical and medical procedures | Systematic Assessment |
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| Hernia repair | Surgical and medical procedures | Systematic Assessment |
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| Ovarian mass removal | Surgical and medical procedures | Systematic Assessment |
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| Back surgery | Surgical and medical procedures | Systematic Assessment |
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| Leg amputation | Surgical and medical procedures | Systematic Assessment |
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| Thyroid surgery | Surgical and medical procedures | Systematic Assessment |
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| Pump placed for incontinence | Surgical and medical procedures | Systematic Assessment |
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| Death due to cancer | General disorders | Systematic Assessment |
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| Fall | General disorders | Systematic Assessment |
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| Edema | Vascular disorders | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |