Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT06495710

Conditions

Hypertension

Vascular Stiffness

Aging

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Blood pressure treatment algorithm

Study Details

Brief summary:

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.

Conditions

Hypertension

Vascular Stiffness

Aging

Study ID

NCT06495710

Start date

May 1, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intensive BP targets

<120 mmHg systolic)

active comparator: Standard blood pressure targets

<140 mmHg systolic

Interventions

Blood pressure treatment algorithm

Single or combination antihypertensive therapy as needed: 1) amlodipine (2.5-10 mg), 2) telmisartan (20-80 mg) or losartan (25-100 mg), 3) chlorthalidone (6.25-25 mg), or 4) spironolactone (12.5-50 mg). a two-drug regimen with either amlodipine + chlorthalidone or telmisartan + chlorthalidone will be initiated following randomization. If a diuretic is contraindicated, amlodipine + telmisartan will be initiated. For those over 75 years, either amlodipine or telmisartan will be initiated at baseline if SBP is <140 mmHg. In the standard treatment group (SBP goal of < 140 mmHg), participants will either be prescribed amlodipine or telmisartan/losartan as initial therapy. If >3 medications are necessary to reach the intensive goal and no first line options remain, potassium sparing diuretics or direct vasodilators will be considered.

Primary outcome measure

  • Load-dependent arterial stiffness measured with pulse wave velocity (m/s) [ Time Frame: 12 months ]
  • Structural arterial stiffness measured with pulse wave velocity (m/s) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Adam Gepner

(608) 256-1901adam.gepner@va.gov

Locations

William S. Middleton Memorial Veterans Hospital, Madison, WI

Recruiting

Madison, Wisconsin, United States, 53705-2254

Contacts

Adam Gepner

608-256-1901adam.gepner@va.gov

Amy J Hein

(608) 280-7222Amy.Hein@va.gov

Principal Investigator:

Adam Gepner

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • hypertension
  • Vascular Stiffness
  • Aging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-13.