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New treatment option for Hypertension
Official title Arterial Stiffness and Blood Pressure
ClinicalTrials.gov ID: NCT06495710
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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...
- 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...
- Participants must be willing to be assigned by chance to intensive or standard blood pressure treatment and have blood pressure medications adjusted...
- They must be willing to undergo tonometric evaluation of arterial stiffness, and carotid artery ultrasound.
You likely can't join if
- 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...
- 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...
- a class I indication for betablocker use including atrial arrhythmias
- left-ventricular systolic function \ moderate aortic stenosis
See the full eligibility 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 assigned by chance 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...
- a class I indication for betablocker use including atrial arrhythmias
- left-ventricular systolic function \ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Nashville, Tennessee, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Nashville, Tennessee, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.