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Behavioural Intervention

Blood Pressure Treatment for High Blood Pressure (LOADED-BP Trial)

N/A
Waitlist Available
Led By Adam Gepner
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female participants from VA VISN 7, 9, and 12 over age 60 years with a diagnosis of hypertension or taking up to 4 antihypertensive medications
Be older than 18 years old
Must not have
Participants with a standing SBP <110 mmHg
Participants with arm circumference unsuitable for accurate blood pressure recordings
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study how different treatment goals for blood pressure affect blood vessel stiffness in older Veterans. The researchers have developed a new method to measure blood vessel stiffness related to blood pressure. They will also

Who is the study for?
This trial is for older adults with high blood pressure, focusing on Veterans. Participants should have hypertension and be interested in how different treatment goals affect arterial stiffness. The study seeks to personalize care by considering vessel physiology and genetics.
What is being tested?
The trial tests a novel blood pressure treatment algorithm that takes into account the stiffness of blood vessels related to aging. It compares intensive versus standard treatment goals and includes genetic analysis to tailor care for cardiovascular health.
What are the potential side effects?
Since specific side effects are not listed, they may include common reactions to blood pressure medications such as dizziness, headaches, fatigue, or swelling due to changes in vascular stiffness and blood pressure management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 60, have high blood pressure, or take up to 4 medications for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is usually below 110 mmHg when standing.
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My arm size makes it hard to measure my blood pressure accurately.
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I need a specific blood pressure medication not in the study or have a known cause for my high blood pressure.
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I had a cardiovascular disease event in the last year.
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I need betablockers, have weak heart pumping, or severe aortic valve narrowing.
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I have had a stroke, chronic kidney disease, proteinuria, or polycystic kidney disease.
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I have active cancer, lung disease needing oxygen, or an autoimmune disease.
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I do not have HIV, a current infection or fever above 38°C, nor have I been hospitalized in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Load-dependent arterial stiffness measured with pulse wave velocity (m/s)
Structural arterial stiffness measured with pulse wave velocity (m/s)
Secondary study objectives
Brachial blood pressure
Total arterial stiffness measured with pulse wave velocity (m/s)
Other study objectives
Safety outcome - Acute Kidney Injury
Safety outcome - Electrolyte abnormalities
Safety outcome - Falls
+1 more

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: Intensive BP targetsExperimental Treatment1 Intervention
\<120 mmHg systolic)
Group II: Standard blood pressure targetsActive Control1 Intervention
\<140 mmHg systolic

Find a Location

Who is running the clinical trial?

The Lundquist InstituteUNKNOWN
University of Wisconsin, MadisonOTHER
1,230 Previous Clinical Trials
3,199,597 Total Patients Enrolled
Nashville VA Medical CenterUNKNOWN
3 Previous Clinical Trials
541 Total Patients Enrolled
~152 spots leftby Dec 2027
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