Intensive Blood Pressure Control for Cognitive Decline

(IMPACTS-MIND Trial)

Overseen by Katherine T Mills, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Tulane University

Must be taking: Antihypertensives

Disqualifiers: Pregnancy, Dementia, Renal disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a plan to aggressively lower blood pressure in racial minority and low-income patients to prevent cognitive decline. The treatment uses various strategies to manage and monitor blood pressure effectively. If successful, this approach could be used widely in primary care settings.

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 data supports the effectiveness of the treatment Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm for cognitive decline?

Research from the SPRINT and STEP trials shows that intensive blood pressure control can reduce the risk of heart-related events in older adults with high blood pressure, which may indirectly support its potential benefits for cognitive health. ^{1 2 3 4 5}

Is intensive blood pressure control generally safe for humans?

Intensive blood pressure control, as studied in the SPRINT trial, can lower the risk of heart problems but may increase the risk of serious side effects, like acute kidney injury (a sudden decrease in kidney function). ^{4 6 7 8 9}

How is the Stepped-care protocol for hypertension different from other treatments for cognitive decline?

The Stepped-care protocol for hypertension, adapted from the SPRINT intensive-treatment algorithm, is unique because it focuses on aggressively lowering systolic blood pressure (the top number in a blood pressure reading) to reduce the risk of cardiovascular events, which may also help in slowing cognitive decline. This approach is more intensive than standard blood pressure treatments, aiming for a lower blood pressure target. ^{1 3 5 10 11}

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

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

James Zanewicz

Tulane University

Chief Medical Officer

MD from Tulane University

Elaine Hamm

Tulane University

Chief Executive Officer since 2022

PhD in Microbiology from the University of Oklahoma

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

Rob Myers

Wake Forest University

Chief Medical Officer

MD from University of Calgary

Tim Bertram

Wake Forest University

Chief Executive Officer

PhD in Veterinary Medicine, Iowa State University

Findings from Research

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]

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 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 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]

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]

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]

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]

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 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]

References

1. United States 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. [2023]

2. Scotland 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. [2023]

3. Switzerland 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. [2023]

4. United States 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). [2018]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension. [2022]

7. Netherlands 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. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Use of advanced statistical techniques to predict all-cause mortality in the Systolic Blood Pressure Intervention Trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Estimated Population Health Benefits of Intensive Systolic Blood Pressure Treatment Among SPRINT-Eligible US Adults. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Intensive Versus Standard Blood Pressure Treatment in Older Patients With Hypertension in China. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

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