Intensive Blood Pressure Control for Cognitive Decline

(IMPACTS-MIND Trial)

Overseen By Erin Peacock, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Must be taking: Antihypertensives

Disqualifiers: Pregnancy, Dementia, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage blood pressure to determine if it can prevent memory problems and dementia, especially in racial minorities and low-income individuals with high blood pressure. Participants will either receive enhanced usual care or follow an intensive blood pressure management plan, which includes regular monitoring and health coaching. This plan is based on the Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm. The trial seeks individuals who have high blood pressure, are 40 years or older, and do not have a dementia diagnosis. This research could lead to better treatment options that are effective and accessible for those most at risk. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve health outcomes for at-risk communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants can be on antihypertensive medications if their systolic blood pressure is 130 mmHg or higher, so you might be able to continue those medications.

What prior data suggests that this protocol is safe for cognitive decline prevention?

Research has shown that the intensive blood pressure approach used in the SPRINT trial is generally well-tolerated by patients. The trial aimed to maintain the systolic blood pressure below 120 mmHg. Studies have found that while this intensive control can cause some side effects, such as dizziness or low blood pressure, these are usually mild and manageable.

In the SPRINT trial, no major differences in memory or thinking skills were observed between those who received intensive blood pressure treatment and those who received standard treatment. This suggests that the approach does not harm brain function. Additionally, the SPRINT protocol was tested with a focus on safety, and no major safety concerns emerged in the available evidence.

Overall, the treatment appears safe based on previous research. However, as with any medical treatment, discussing potential risks and benefits with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Intensive Blood Pressure Control protocol for slowing cognitive decline because it takes a more proactive, structured approach compared to typical hypertension treatments. Unlike standard care, which often relies on general medication and lifestyle advice, this protocol uses the SPRINT intensive blood pressure management algorithm. This approach involves a combination of personalized treatment plans, team-based care, regular blood pressure monitoring, and health coaching. Researchers hope this method will not only better control blood pressure but also slow down cognitive decline, offering a dual benefit that current treatments may not fully achieve.

What evidence suggests that the stepped-care protocol is effective for reducing cognitive decline?

Research has shown that maintaining low blood pressure can slow memory and thinking problems. In this trial, participants in the intervention arm will follow a protocol-based treatment using the SPRINT intensive BP management algorithm, targeting a systolic blood pressure of less than 120. The Systolic Blood Pressure Intervention Trial (SPRINT) found that this method not only reduces blood pressure but also appears to protect the brain. Specifically, individuals who followed this intensive treatment plan experienced a slower decline in cognitive abilities compared to those receiving standard blood pressure care. This suggests that more aggressive blood pressure management might help preserve cognitive function longer. Meanwhile, participants in the enhanced usual care arm will receive education on hypertension guidelines but will otherwise follow routine clinic practices. ^{1 2 4 6 7}

Who Is on the Research Team?

Jiang He, MD, PhD

Principal Investigator

Tulane University

Jeff D Williamson, MD

Principal Investigator

Wake Forest University

Katherine T Mills, PhD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

This trial is for men and women aged 40 or older, primarily over 60, with high blood pressure who are patients at certain primary care clinics. It focuses on underserved populations such as ethnic minorities and low-income groups. Pregnant women or those not using birth control are excluded, along with anyone unable to consent.

Inclusion Criteria

The study is focused on helping people who have less access to healthcare because of their ethnicity, income, or where they live.

Your blood pressure is too high (above 140/130 mmHg) even with medication.

You are not already enrolled in another program to control high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive protocol-based treatment using the SPRINT intensive BP management algorithm, including team-based collaborative care, home BP monitoring, and health coaching

36 months

Regular visits for BP monitoring and health coaching

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm

Trial Overview The study tests a stepped-care approach aiming for systolic blood pressure below 120 mmHg to slow cognitive decline in racial minority and low-income patients. The strategy could be expanded if successful in preventing cognitive issues related to high blood pressure.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The core component of the intervention is protocol-based treatment using the SPRINT intensive BP management algorithm. Implementation strategies include dissemination of SPRINT study findings, team-based collaborative care and shared-decision making, blood pressure audit and feedback, home blood pressure monitoring, and health coaching.

Group II: Enhanced Usual Care Active Control 1 Intervention

Enhanced usual care will include an education session on the ACC/AHA hypertension guideline to providers and proper BP measurement to providers and staff at enhanced usual care clinics.Otherwise, no active intervention will take place, and all usual care clinics will follow their routine clinic practice.

Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm is already approved in United States for the following indications:

Approved in United States as SPRINT intensive-treatment algorithm for:

• Hypertension management
• Prevention of cognitive decline

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

Published Research Related to This Trial

In the STEP trial involving 6,501 hypertensive patients aged 60-80 years, intensive blood pressure control (targeting 110-130 mmHg) did not significantly improve cognitive function compared to standard treatment (130-150 mmHg) over a median follow-up of 3.34 years.

Both treatment groups showed similar rates of cognitive decline, with only 1.4% in the intensive group and 1.3% in the standard group experiencing cognitive decline, indicating that intensive blood pressure lowering does not have a clear benefit on cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intensive vs. standard blood pressure control on cognitive function: Post-hoc analysis of the STEP randomized controlled trial. Fan, J., Bai, J., Liu, W., et al.[2023]

In the SPRINT trial, patients in the intensive blood pressure treatment group, targeting systolic blood pressure (SBP) below 120 mm Hg, experienced a significant reduction in all-cause mortality (hazard ratio of 0.73) compared to those in the standard treatment group over 3.26 years.

Patients receiving more than one blood pressure-lowering medication had a higher risk of all-cause mortality, and a U-shaped relationship was observed between SBP and mortality, particularly in the standard treatment group, indicating that both very low and high SBP levels may be associated with increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of advanced statistical techniques to predict all-cause mortality in the Systolic Blood Pressure Intervention Trial. Kostis, WJ., Cabrera, J., Lin, CP., et al.[2022]

In the SPRINT trial involving 9361 patients, intensive blood pressure control (<120 mm Hg) led to a lower average risk of major adverse cardiovascular events (MACE) or death, but also resulted in a higher average risk of serious adverse events (SAE) compared to standard control (<140 mm Hg).

Prediction models were developed to help tailor blood pressure treatment goals based on individual patient risk, showing that while intensive treatment can reduce MACE/death risk by an average of 2.2%, it can increase the risk of SAEs by the same amount, highlighting the need for personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalizing the Intensity of Blood Pressure Control: Modeling the Heterogeneity of Risks and Benefits From SPRINT (Systolic Blood Pressure Intervention Trial). Patel, KK., Arnold, SV., Chan, PS., et al.[2018]

In the US, 23.77% of elderly adults (about 12.46 million) meet the SPRINT trial criteria for intensive blood pressure treatment, while in China, 38.89% (approximately 85.39 million) meet the STEP trial criteria, indicating a significant population that could benefit from such interventions.

Implementing intensive blood pressure treatment could prevent or postpone approximately 70,000 deaths annually in the US and 310,000 in China, highlighting the potential life-saving impact of scaling up these treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generalisability and potential deaths averted from intensive blood pressure treatment among the elderly population in the US and China: A nationally representative cross-sectional study. Li, C., Yang, C., Shao, F., et al.[2023]

In a study of 2847 nondiabetic patients over a mean follow-up of 3.3 years, thiazide use significantly reduced the risk of cardiovascular events, especially heart failure, in those receiving intensive blood pressure treatment.

Thiazide use was also linked to a lower risk of all-cause mortality, although it did increase the occurrence of hypokalemia (low potassium levels) in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thiazide Use and Decreased Risk of Heart Failure in Nondiabetic Patients Receiving Intensive Blood Pressure Treatment. Tsujimoto, T., Kajio, H.[2021]

In the SPRINT trial, patients with higher baseline cardiovascular disease (CVD) risk benefited more from intensive blood pressure treatment, while those with lower risk experienced more harm than benefit, highlighting the importance of risk stratification in treatment decisions.

The study found that the number needed to treat to prevent primary outcomes decreased significantly with higher CVD risk, while the number needed to harm for serious adverse events increased, indicating a favorable benefit-to-harm ratio for intensive treatment in higher-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension. Phillips, RA., Xu, J., Peterson, LE., et al.[2022]

Intensive blood pressure treatment significantly reduced the risk of cardiovascular events in older patients compared to standard treatment, with 36.88% of patients experiencing events in the intensive group versus 41.28% in the standard group.

The study found that intensive treatment provided an additional 0.16 quality-adjusted life-years at a cost of 12,614 Chinese yuan per quality-adjusted life-year gained, making it cost-effective in 82%-95% of scenarios analyzed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Intensive Versus Standard Blood Pressure Treatment in Older Patients With Hypertension in China. Fan, J., Zheng, W., Liu, W., et al.[2022]

The STEP trial is a large-scale study involving 8511 elderly patients (aged 60-80) with primary hypertension, comparing the effects of intensive blood pressure treatment (targeting SBP 110-130 mmHg) versus mild treatment (targeting SBP 130-150 mmHg) on cardiovascular events over an average follow-up of four years.

This trial will also evaluate the effectiveness of smartphone app management in controlling blood pressure, potentially offering new insights into improving adherence and outcomes in elderly hypertensive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): Rational, design, and baseline characteristics for the main trial. Zhang, S., Wu, S., Ren, J., et al.[2021]

A new risk estimation tool was developed using data from 8760 participants in the Systolic Blood Pressure Intervention Trial (SPRINT) to compare the risks of cardiovascular events and acute kidney injury (AKI) between intensive and standard blood pressure treatments.

The tool, validated with high accuracy (areas under the curve of 0.70 for cardiovascular outcomes and 0.77 for AKI), helps identify patients who may benefit most from intensive blood pressure control while considering the potential risks of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Easy-to-use tool for evaluating the elevated acute kidney injury risk against reduced cardiovascular disease risk during intensive blood pressure control. Venäläinen, MS., Klén, R., Mahmoudian, M., et al.[2021]

Intensive systolic blood pressure (SBP) treatment (<120 mm Hg) significantly reduces cardiovascular disease (CVD) risk, with an estimated prevention of 84,300 CVD events annually among 14.1 million SPRINT-eligible adults in the U.S.

The study identified that targeting individuals with medium or high predicted benefit from intensive SBP treatment could maximize population health benefits, as these groups accounted for a substantial portion of the potential CVD event reductions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimated Population Health Benefits of Intensive Systolic Blood Pressure Treatment Among SPRINT-Eligible US Adults. Derington, CG., Bress, AP., Berchie, RO., et al.[2023]

In elderly hypertensive patients, intensive blood pressure treatment (targeting SBP of 110-130 mmHg) resulted in significantly lower systolic blood pressure compared to standard treatment (130-150 mmHg) over a median follow-up of 40 months.

Despite the lower blood pressure, intensive treatment was associated with decreased myocardial work parameters (global work index and global constructive work), indicating that while blood pressure control is achieved, it may not lead to improved heart function efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intensive blood-pressure treatment on myocardial work in elderly hypertensive patients: A subcenter study of the STEP randomized controlled trial. Feng, X., Yan, M., Tang, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4156910/

The Systolic Blood Pressure Intervention Trial (SPRINT) - PMC We also hypothesize that compared to the Standard Group, the Intensive Group will have slower decline in a composite measure of general cognitive function ...

2. sprinttrial.org sprinttrial.org/public/Protocol_Current.pdf

Systolic Blood Pressure Intervention Trial (SPRINT) Protocol ... Secondary outcomes include all-cause mortality, decline in renal function or development of end stage renal disease (ESRD), dementia, decline in cognitive ...

3. clinicaltrial.be clinicaltrial.be/en/details/46419?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Implementation of Multifaceted Patient-Centered Treatment... Stepped-care protocol adapted from the SPRINT intensive-treatment algorithmBEHAVIORAL. Study arms: Intervention. The core component of the ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04797403/implementation-of-multifaceted-patient-centered-treatment-strategies-for-intensive-blood-pressure-control-in-minimize-cognitive-decline

Implementation of Multifaceted Patient-Centered Treatment ... The overall objective of the proposed study is to test a multifaceted strategy for implementing an intensive BP intervention protocol adapted ...

5. withpower.com withpower.com/trial/phase-3-cognitive-dysfunction-9-2019-65510

Intensive Blood Pressure Control for Cognitive Decline What data supports the effectiveness of the treatment Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm for cognitive decline?

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9930906/

Effects of intensive vs. standard blood pressure control on ... Compared with standard treatment, intensive SBP treatment did not result in a significant change in cognitive function test score.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/62/NCT01206062/Prot_000.pdf

Systolic Blood Pressure Intervention Trial (SPRINT) ... Secondary outcomes include all-cause mortality, decline in renal function or development of end stage renal disease (ESRD), dementia, decline in ...