Assessing blood pressure treatment effects on arterial stiffness in older veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how different blood pressure treatment goals affect arterial stiffness in older veterans with hypertension. It utilizes non-invasive methods to measure arterial stiffness and incorporates genetic analysis to personalize treatment approaches. Participants will be randomized to receive either intensive or standard blood pressure treatment, and their responses will be monitored through various assessments. The goal is to bridge the gap in hypertension management by providing tailored care based on individual physiological and genetic factors.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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

Where it's running

• William S. Middleton Memorial Veterans Hospital, Madison, WI
  Madison, Wisconsin, United States Recruiting
• Birmingham VA Medical Center, Birmingham, AL
  Birmingham, Alabama, United States Not yet recruiting
• Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  Nashville, Tennessee, United States Enrolling by invitation

Study contacts

• Principal investigator: Adam Gepner — William S. Middleton Memorial Veterans Hospital, Madison, WI
• Study coordinator: Adam Gepner
• Email: adam.gepner@va.gov
• Phone: (608) 256-1901

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.