1260 Participants Needed

Intensive Blood Pressure Control for Cognitive Decline

(IMPACTS-MIND Trial)

EP
Overseen ByErin Peacock, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Tulane University
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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).12345

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.678910

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.367911

Who Is on the Research Team?

JH

Jiang He, MD, PhD

Principal Investigator

Tulane University

JD

Jeff D Williamson, MD

Principal Investigator

Wake Forest University

KT

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.
See 7 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention

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:

Find a Clinic Near You

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 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.
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.
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.
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]

Citations

Effects of intensive blood-pressure treatment on myocardial work in elderly hypertensive patients: A subcenter study of the STEP randomized controlled trial. [2023]
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]
Effects of intensive vs. standard blood pressure control on cognitive function: Post-hoc analysis of the STEP randomized controlled trial. [2023]
Personalizing the Intensity of Blood Pressure Control: Modeling the Heterogeneity of Risks and Benefits From SPRINT (Systolic Blood Pressure Intervention Trial). [2018]
Strategy of blood pressure intervention in the elderly hypertensive patients (STEP): Rational, design, and baseline characteristics for the main trial. [2021]
Impact of Cardiovascular Risk on the Relative Benefit and Harm of Intensive Treatment of Hypertension. [2022]
Easy-to-use tool for evaluating the elevated acute kidney injury risk against reduced cardiovascular disease risk during intensive blood pressure control. [2021]
Use of advanced statistical techniques to predict all-cause mortality in the Systolic Blood Pressure Intervention Trial. [2022]
Estimated Population Health Benefits of Intensive Systolic Blood Pressure Treatment Among SPRINT-Eligible US Adults. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Cost-Effectiveness of Intensive Versus Standard Blood Pressure Treatment in Older Patients With Hypertension in China. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Thiazide Use and Decreased Risk of Heart Failure in Nondiabetic Patients Receiving Intensive Blood Pressure Treatment. [2021]
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