Blood Pressure Treatment for High Blood Pressure

(LOADED-BP Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Adam Gepner

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

Hypertension is a common and treatable disorder that remains the leading preventable cause of heart disease. Blood pressure treatment relies mainly on upper arm blood pressure readings and ignores blood vessel physiology and underlying individual genetic information. Older Veterans with hypertension are less likely to be treated to goal blood pressure because there are conflicting recommendations for what constitutes "optimal" in older adults. The investigators have developed a novel way to non-invasively assess the components of blood vessel stiffness that is related to blood pressure (load-dependent stiffness). This project will generate new knowledge about how different blood pressure treatment goals (intensive vs standard) impact different components of arterial stiffness and if these differences can be explained through genetic analysis. Results from this project will offer the VA an updated blueprint for personalizing blood pressure care in older adults, ultimately improving cardiovascular health.

Research Team

Adam Gepner

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Eligibility Criteria

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.

Inclusion Criteria

I am over 60, have high blood pressure, or take up to 4 medications for it.

Veterans with documented SBP readings on 2 or more office visits of 140 mmHg or average home blood pressure readings of 135 mmHg

I am willing to follow the study's blood pressure treatment plan and undergo specific heart health tests.

Exclusion Criteria

I do not have HIV, a current infection or fever above 38°C, nor have I been hospitalized in the last 4 weeks.

Participants with factors limiting adherence to study interventions or follow-up such as active substance abuse, plans to move outside study catchment areas within 12 months, or history of poor medication adherence or clinic no-shows

My blood pressure is usually below 110 mmHg when standing.

Treatment Details

Interventions

• Blood pressure treatment algorithm (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Intensive BP targets Experimental Treatment 1 Intervention

\<120 mmHg systolic)

Group II: Standard blood pressure targets Active Control 1 Intervention

\<140 mmHg systolic

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

The Lundquist Institute

Collaborator

Trials

1

Recruited

230+

University of Wisconsin, Madison

Collaborator

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Nashville VA Medical Center

Collaborator

Trials

4

Recruited

770+

Birmingham, Alabama VA Medical Center

Collaborator

Trials

4

Recruited

530+

VA Tennessee Valley Health Care System

Collaborator

Trials

5

Recruited

1,400+