No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
60 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
228 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for older veterans who have high blood pressure. Participants will be randomly assigned to different blood pressure treatment methods and will undergo tests to measure their blood vessel stiffness.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 60 years old
I have been diagnosed with high blood pressure
I take up to 4 medications for high blood pressure
I have been to the doctor for blood pressure checks
I am willing to try different blood pressure treatments
I agree to have tests on my blood vessels
You may not be able to join if
I have had a major heart event in the past year
I have low blood pressure when standing
I have a history of stroke
I have heart or kidney issues
I have active cancer (with some exceptions)
I have ongoing lung disease
I have been hospitalized in the last 4 weeks
I do not follow medication or appointment schedules well
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
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 …
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
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