Hypertension, SystolicNCT01650402

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

A study testing Anti-hypertensive therapy to SBP 130 mm Hg and Anti-hypertensive therapy to SBP 145 mm Hg in people with Hypertension, Systolic and Cerebrovascular Disease, run by UConn Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 75 years and older
Conditions the study is for: Hypertension, Systolic, Cerebrovascular Disease
What is being tested?: Anti-hypertensive therapy to SBP 130 mm Hg and Anti-hypertensive therapy to SBP 145 mm Hg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Connecticut Health Center
Farmington, Connecticut, 06030

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions: Hypertension, Systolic, Cerebrovascular Disease
Being tested: Anti-hypertensive therapy to SBP 130 mm Hg, Anti-hypertensive therapy to SBP 145 mm Hg
Keywords: Hypertension, systolic, Elderly (> or equal to 75 years), Cerebrovascular disease
Medical subject headings: Isolated Systolic Hypertension, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anti-hypertensive therapy to SBP 130 mm HgOther
Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
Anti-hypertensive therapy to SBP 145 mm HgOther
Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg

Study groups in NCT01650402
Study group	Role	What they receive
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 Receives: 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 Receives: Other: Anti-hypertensive therapy to SBP 145 mm Hg

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Change from baseline to 36 months

Secondary outcomes (1)

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.
Measured: Change from baseline to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Oct 2018

First posted26 Jul 2012 (estimated)
Study startDec 2011
Primary completionOct 2018
Study completionOct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Hypertension, SystolicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01650402
Sponsor's protocol ID: 11-155S-2
Other IDs: 2R01AG022092-06A1
Status last verified: Oct 2020
First submitted: 14 Dec 2011
Last updated: 18 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 36398903
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.
PubMed 32905623
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.
PubMed 31607143
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.
PubMed 30145340
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.
PubMed 23453090

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
ClinicalTrials.gov ID: NCT01650402
Acronym / sponsor ID: 11-155S-2
Conditions: Hypertension, Systolic, Cerebrovascular Disease
Keywords: Hypertension, systolic, Elderly (> or equal to 75 years), Cerebrovascular disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: UConn HealthUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Dec 2011
Primary completion: Oct 2018 (actual)
Study completion: Oct 2018 (actual)
First posted: 26 Jul 2012 (estimated)
Results: Posted 30 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intensive	Experimental	Other: Anti-hypertensive therapy to SBP 130 mm HgIntensive 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	Other: Anti-hypertensive therapy to SBP 145 mm HgStandard anti-hypertensive therapies using standard blood pressure medications to lower blood pressure to a level less than or equal to 145 mmHg

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anti-hypertensive therapy to SBP 130 mm HgAnti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg	Other	Intensive
Anti-hypertensive therapy to SBP 145 mm HgAnti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg	Other	Standard

Primary outcome

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).

1 secondary outcome

Cognitive Function - as Measured by Change in Stroop Test Score
Time frame: Change from baseline to 36 months

Results and safety

Results posted to the registry on 30 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intensive	99	79
Standard	100	86

Primary outcome: Mobility - Measured by Change in Gait Speed

Time frame: Change from baseline to 36 months. Mean (Standard Deviation). Unit: seconds

Measure	Intensive n = 78	Standard n = 86
Value	0.4 (2.0)	0.42 (2.73)

Population analysed: 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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected throughout a participant's study completion, an average of 36 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intensive	33 of 99 (33.3%)	86 of 99 (86.9%)	2 of 99
Standard	36 of 100 (36%)	70 of 100 (70%)	4 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36398903Saiz 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.
Derived from this study: PubMed 32905623Saiz 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.
Derived from this study: PubMed 31607143White 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.
Derived from this study: PubMed 30145340White 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.
Derived from this study: PubMed 23453090White 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William B. White, M.D. principal investigator

Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center

Leslie Wolfson, M.D. principal investigator

Department of Neurology, University of Connecticut Health Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mobility - Measured by Change in Gait Speed (time frame: Change from baseline to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01650402, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.