RECRUITING

Arterial Stiffness and Blood Pressure

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Load-Dependent Arterial Stiffness to Optimize Blood Pressure Management in Older Veterans (LOADED BP)

Quick Facts

Study Start:2025-05-01

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06495710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male and female participants from VA VISN 7, 9, and 12 will be eligible to participate if they are over age 60 years and have a diagnosis of hypertension or take antihypertensive medications (up to 4). * Veterans will require documented SBP readings on 2 or more office visits that are 140 mmHg or average home blood pressure readings 135 mmHg to be eligible for the trial. * Participants must be willing to be randomized to intensive or standard blood pressure treatment and have blood pressure medications adjusted per the study protocol. * They must be willing to undergo tonometric evaluation of arterial stiffness, and carotid artery ultrasound.	* Participants who have an indication for a specific BP lowering medication that is not included in the study protocol or a known secondary cause of hypertension will be excluded. * Patients will be excluded if they have: * a standing SBP \<110 mmHg * past history of a recent CVD event in the past 12 months (i.e., coronary artery disease event/intervention, congestive heart failure exacerbation or heart failure hospitalization, atrial fibrillation, or peripheral arterial disease intervention) * a class I indication for betablocker use including atrial arrhythmias * left-ventricular systolic function \<50%, \>moderate aortic stenosis * history of stroke * chronic kidney disease (eGFR\<30 mL/min/m2) or proteinuria in excess of 1 gram/day or polycystic kidney disease * active cancer (other than untreated, non-metastatic prostate cancer and non-melanoma skin cancer) * hypoxemic pulmonary disease * active rheumatologic or connective tissue diseases (i.e., systemic lupus erythematosus, rheumatoid arthritis, etc.) * human immunodeficiency virus * illness with any infectious etiology or fever \>38°C (i.e., upper respiratory illness, gastrointestinal illness, etc.) * hospitalization for any reason within the prior 4 weeks * Participants will be excluded if arm circumference is too large/small to allow accurate blood pressure recordings * The investigators will also exclude those with factors that may limit adherence to the study interventions or follow-up including active substance abuse, plans to move outside the study catchment areas within 12 months or a history of poor medication adherence or clinic no-shows

Inclusion Criteria

Exclusion Criteria

* Male and female participants from VA VISN 7, 9, and 12 will be eligible to participate if they are over age 60 years and have a diagnosis of hypertension or take antihypertensive medications (up to 4).
* Veterans will require documented SBP readings on 2 or more office visits that are 140 mmHg or average home blood pressure readings 135 mmHg to be eligible for the trial.
* Participants must be willing to be randomized to intensive or standard blood pressure treatment and have blood pressure medications adjusted per the study protocol.
* They must be willing to undergo tonometric evaluation of arterial stiffness, and carotid artery ultrasound.

* Participants who have an indication for a specific BP lowering medication that is not included in the study protocol or a known secondary cause of hypertension will be excluded.
* Patients will be excluded if they have:
* a standing SBP \<110 mmHg
* past history of a recent CVD event in the past 12 months (i.e., coronary artery disease event/intervention, congestive heart failure exacerbation or heart failure hospitalization, atrial fibrillation, or peripheral arterial disease intervention)
* a class I indication for betablocker use including atrial arrhythmias
* left-ventricular systolic function \<50%, \>moderate aortic stenosis
* history of stroke
* chronic kidney disease (eGFR\<30 mL/min/m2) or proteinuria in excess of 1 gram/day or polycystic kidney disease
* active cancer (other than untreated, non-metastatic prostate cancer and non-melanoma skin cancer)
* hypoxemic pulmonary disease
* active rheumatologic or connective tissue diseases (i.e., systemic lupus erythematosus, rheumatoid arthritis, etc.)
* human immunodeficiency virus
* illness with any infectious etiology or fever \>38°C (i.e., upper respiratory illness, gastrointestinal illness, etc.)
* hospitalization for any reason within the prior 4 weeks
* Participants will be excluded if arm circumference is too large/small to allow accurate blood pressure recordings
* The investigators will also exclude those with factors that may limit adherence to the study interventions or follow-up including active substance abuse, plans to move outside the study catchment areas within 12 months or a history of poor medication adherence or clinic no-shows

Contacts and Locations

Study Contact

Adam Gepner

CONTACT

(608) 256-1901

adam.gepner@va.gov

Principal Investigator

Adam Gepner

PRINCIPAL_INVESTIGATOR

William S. Middleton Memorial Veterans Hospital, Madison, WI

Study Locations (Sites)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927

United States

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637

United States

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Adam Gepner, PRINCIPAL_INVESTIGATOR, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-05-01

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

hypertension
Vascular Stiffness
Aging

Additional Relevant MeSH Terms

Hypertension
Vascular Stiffness
Aging