What side effects are associated with this type of intervention?

Common treatments for high blood pressure, particularly those used in intensive blood pressure reduction, can have several side effects. These include hypotension (low blood pressure), syncope (fainting), bradycardia (slow heart rate), arrhythmia (irregular heartbeat), hyperkalemia (high potassium levels), angioedema (swelling under the skin), and kidney failure. Intensive blood pressure lowering can also lead to acute kidney injury and an increase in serum creatinine, indicating potential kidney stress. Chronic kidney disease (CKD) incidence may also rise with intensive therapy.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including ACE inhibitors (e.g., enalapril, lisinopril), beta blockers (e.g., atenolol, metoprolol), calcium channel blockers (e.g., amlodipine, verapamil), and diuretics (e.g., hydrochlorothiazide). These medications have been studied extensively and are commonly used in clinical practice. For intensive blood pressure reduction, which aims to lower systolic BP to less than 120 mmHg to reduce cognitive decline, these classes of drugs are often employed either alone or in combination. The effectiveness and safety of these medications have been validated through numerous clinical trials, making them integral to hypertension management strategies.

What other types of research exist?

Promising alternatives to intensive blood pressure reduction for high blood pressure patients include: 1) The DASH diet, which is rich in fruits, vegetables, legumes, and low-fat dairy products, has been shown to significantly reduce blood pressure. 2) Combination antihypertensive therapy, particularly using ACE inhibitors or ARBs, which are effective in managing hypertension and reducing cardiovascular risks. 3) Regular physical activity and weight management, which have been proven to lower blood pressure and improve overall cardiovascular health. These alternatives can be considered in consultation with a healthcare provider to tailor the best approach for individual patients.

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Intensive Blood Pressure Control for Cognitive Decline (IMPACTS-MIND Trial)

N/A

Recruiting

Led By Jiang He, MD, PhD

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to an average of 36 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial's description does not specify side effects, intensive blood pressure control can sometimes lead to dizziness, fainting, kidney problems or electrolyte imbalances due to lower than usual BP levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to an average of 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to an average of 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to an average of 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Net difference in mean change in cognitive decline

Secondary study objectives

Net difference in mean change in MoCA score

Net difference in mean change in diastolic blood pressure

Net difference in mean change in executive function

+2 more

Other study objectives

Difference in proportion of patients with adjudicated mild cognitive impairment (MCI) or probable dementia (exploratory outcome)

Health-related Quality of Life (HRQoL)

Side effects

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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 CareActive Control1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include ACE inhibitors and ARBs, which relax blood vessels by inhibiting the renin-angiotensin system; calcium channel blockers, which prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels; diuretics, which help the kidneys remove excess sodium and water, reducing blood volume; and beta-blockers, which reduce heart rate and the force of contraction. These mechanisms are essential for achieving intensive blood pressure targets, such as lowering systolic BP to <120 mmHg, which can significantly reduce the risk of cardiovascular events and cognitive decline in hypertensive patients.

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Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,800 Previous Clinical Trials

28,192,266 Total Patients Enrolled

Tulane UniversityLead Sponsor

123 Previous Clinical Trials

238,228 Total Patients Enrolled

Wake Forest UniversityOTHER

192 Previous Clinical Trials

164,976 Total Patients Enrolled

Jiang He, MD, PhDPrincipal InvestigatorTulane University

9 Previous Clinical Trials

26,711 Total Patients Enrolled

Jeff D Williamson, MDPrincipal InvestigatorWake Forest University

Katherine T Mills, PhD2.52 ReviewsPrincipal Investigator - Tulane University

Tulane University

1 Previous Clinical Trials

256 Total Patients Enrolled

4Patient Review

Dr. Mills is an excellent Gynecologic Oncologist working out of Northwest Community Hospital. She is highly skilled and experienced in cancer surgery, and was able to provide me with the information and support I needed when I was first diagnosed. Though she also encouraged me to lose weight for other health reasons, which wasn't something I wanted to hear at that moment, she is ultimately a highly competent and caring doctor that I would recommend to others.