HypertensionLOADED-BPNCT06495710
Arterial Stiffness and Blood Pressure
A study testing Blood pressure treatment algorithm in people with Hypertension and Vascular Stiffness, run by VA Office of Research and Development at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension, Vascular Stiffness, Aging
- What is being tested?
- Blood pressure treatment algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927
Nicole Lohr, MD, 205-934-9166
- Recruiting
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
Adam Gepner, 608-256-1901 ext. 12984, adam.gepner@va.gov
Amy J Hein, (608) 280-7222, Amy.Hein@va.gov
- Enrolling by invitation
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
About this study
Official title: Load-Dependent Arterial Stiffness to Optimize Blood Pressure Management in Older Veterans (LOADED BP)
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.
Read the detailed description
Aims and Rationale: Hypertension is ubiquitous within the VA system and is the leading cause of preventable cardiovascular disease in the United States. Over 1/3 of Veterans with hypertension are not treated to goal, and there are significant differences between professional guideline statement recommendations. A critical knowledge-practice gap exists in blood pressure (BP) management: Treatment decisions in older adults rely mainly on brachial artery BP measurements, ignoring arterial stiffness mechanisms and the underlying genetics of hypertension. The investigators need non-invasive tools to identify older adults most likely to benefit from more intensive BP targets. The investigators plan to evaluate novel physiologic mechanistic arterial stiffness measures (load-dependent stiffness and structural stiffness) and a known BP polygenic risk score (PRS) to improve hypertension care in older Veterans. Total arterial stiffness (e.g., arterial wall rigidity) has two distinct components: 1) structural stiffening due to arterial wall remodeling (e.g., elastin degradation and fibrin and collagen deposition) and 2) load-dependent stiffness, by which elevated BP increases collagen fiber loading. The investigators hope to use these tools to improve the understanding of individual differences in BP treatment responses. The investigators plan to determine if intensive vs. standard BP treatment (i.e., <120 vs. <140 mmHg) improves arterial stiffness components (load-dependent and structural) in older hypertensive Veterans with baseline systolic BP 140 mmHg) over 12 months and determine if baseline load dependent stiffness is associated with BP response regardless of treatment group. Finally, the investigators will determine if a BP PRS can be used to explain individual variability in stiffness responses. A straightforward non-invasive arterial stiffness test, like load dependent stiffness, combined with genetic markers, could improve hypertension and CVD outcomes by personalizing treatment plans in this at-risk Veteran demographic.
Methods: The investigators propose a three-site randomized controlled trial that will enroll hypertensive Veterans 60 years old (n=228). Participants will be randomized 1:1 to intensive or standard BP treatment (<120 vs <140 mmHg). The primary outcomes of load-dependent and structural arterial stiffness will be assessed at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy. Medications will be prescribed and titrated at each visit, and serious adverse effects including hypotension, acute kidney injury and falls will be documented. This will permit the analysis of the impact of BP treatment goals of the mechanistic components of arterial stiffness in older Veterans (primary outcome) and improve the understanding of the underlying genetic factors related to the individual differences in stiffness mechanisms and their specific BP response to treatment goals.
Innovation/Significance: BP control is a major unaddressed problem in the VA Health system. Load-dependent arterial stiffness measures and a BP PRS may provide a novel way to personalize BP goals in older adults and offer new insights into complex phenotypic and genetic differences in BP response. The interaction between blood pressure and stiffness is well described for total arterial stiffness measures, but the impact of standard vs. intensive blood pressure targets on both phenotypic arterial stiffness (load-dependent vs structural stiffness) and genotypic associations with a blood pressure specific polygenic risk score (PRS) has not been studied in older adults. This non-invasive stiffness test could be used as a novel risk-stratification tool to help identify older patients who would benefit from the most aggressive BP treatment goals, ultimately decreasing CVD events in this at-risk population. This will facilitate further studies that could eventually lead to the use of these techniques in clinical settings, allowing prescribers to easily and non-invasively identify older Veterans at the highest CVD risk and more easily assign optimal blood pressure targets to each patient.
- Conditions
- Hypertension, Vascular Stiffness, Aging
- Being tested
- Blood pressure treatment algorithm
- Keywords
- hypertension, Vascular Stiffness, Aging
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure treatment algorithmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive BP targets | Experimental | <120 mmHg systolic) Receives: Other: Blood pressure treatment algorithm |
| Standard blood pressure targets | Active comparator | <140 mmHg systolic Receives: Other: Blood pressure treatment algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Load-dependent arterial stiffness measured with pulse wave velocity (m/s)
Load dependent stiffening is measured with ultrasound and tonometry and is the stiffness component due to elevated blood pressure increasing collagen fiber loading without an intrinsic change to the artery wall. The primary outcomes of load-dependent stiffness will be assessed at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy.
Measured: 12 months
Structural arterial stiffness measured with pulse wave velocity (m/s)
Structural stiffening is measured with ultrasound and tonometry and is the stiffness component due to growth (eg. intima-media thickening) and remodeling (eg. elastin fragmentation, collagen accumulation) of the arterial wall. The primary outcomes of structural arterial stiffness will be assessed at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy.
Measured: 12 months
Secondary outcomes (2)
Total arterial stiffness measured with pulse wave velocity (m/s)
Local total arterial stiffness measured by tonometry and regional arterial stiffness measured by tonometry. This will be measured at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy.
Measured: 12 months
Brachial blood pressure
Upper arm brachial blood blood pressure measurements (mmHg).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Tennessee Valley Health Care System, Birmingham, Alabama VA Medical Center, The Lundquist Institute, University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Adam Gepner, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495710
- Sponsor's protocol ID
- CARB-007-23F
- Acronym
- LOADED-BP
- Status last verified
- Apr 2026
- First submitted
- 24 May 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Load-Dependent Arterial Stiffness to Optimize Blood Pressure Management in Older Veterans (LOADED BP)
- ClinicalTrials.gov ID
- NCT06495710
- Acronym / sponsor ID
- LOADED-BP / CARB-007-23F
- Conditions
- Hypertension, Vascular Stiffness, Aging
- Keywords
- hypertension, Vascular Stiffness, Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Tennessee Valley Health Care System, Birmingham, Alabama VA Medical Center, The Lundquist Institute, University of Wisconsin, Madison
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aims and Rationale: Hypertension is ubiquitous within the VA system and is the leading cause of preventable cardiovascular disease in the United States. Over 1/3 of Veterans with hypertension are not treated to goal, and there are significant differences between professional guideline statement recommendations. A critical knowledge-practice gap exists in blood pressure (BP) management: Treatment decisions in older adults rely mainly on brachial artery BP measurements, ignoring arterial stiffness mechanisms and the underlying genetics of hypertension. The investigators need non-invasive tools to identify older adults most likely to benefit from more intensive BP targets. The investigators plan to evaluate novel physiologic mechanistic arterial stiffness measures (load-dependent stiffness and structural stiffness) and a known BP polygenic risk score (PRS) to improve hypertension care in older Veterans. Total arterial stiffness (e.g., arterial wall rigidity) has two distinct components: 1) structural stiffening due to arterial wall remodeling (e.g., elastin degradation and fibrin and collagen deposition) and 2) load-dependent stiffness, by which elevated BP increases collagen fiber loading. The investigators hope to use these tools to improve the understanding of individual differences in BP treatment responses. The investigators plan to determine if intensive vs. standard BP treatment (i.e., <120 vs. <140 mmHg) improves arterial stiffness components (load-dependent and structural) in older hypertensive Veterans with baseline systolic BP 140 mmHg) over 12 months and determine if baseline load dependent stiffness is associated with BP response regardless of treatment group. Finally, the investigators will determine if a BP PRS can be used to explain individual variability in stiffness responses. A straightforward non-invasive arterial stiffness test, like load dependent stiffness, combined with genetic markers, could improve hypertension and CVD outcomes by personalizing treatment plans in this at-risk Veteran demographic.
Methods: The investigators propose a three-site randomized controlled trial that will enroll hypertensive Veterans 60 years old (n=228). Participants will be randomized 1:1 to intensive or standard BP treatment (<120 vs <140 mmHg). The primary outcomes of load-dependent and structural arterial stiffness will be assessed at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy. Medications will be prescribed and titrated at each visit, and serious adverse effects including hypotension, acute kidney injury and falls will be documented. This will permit the analysis of the impact of BP treatment goals of the mechanistic components of arterial stiffness in older Veterans (primary outcome) and improve the understanding of the underlying genetic factors related to the individual differences in stiffness mechanisms and their specific BP response to treatment goals.
Innovation/Significance: BP control is a major unaddressed problem in the VA Health system. Load-dependent arterial stiffness measures and a BP PRS may provide a novel way to personalize BP goals in older adults and offer new insights into complex phenotypic and genetic differences in BP response. The interaction between blood pressure and stiffness is well described for total arterial stiffness measures, but the impact of standard vs. intensive blood pressure targets on both phenotypic arterial stiffness (load-dependent vs structural stiffness) and genotypic associations with a blood pressure specific polygenic risk score (PRS) has not been studied in older adults. This non-invasive stiffness test could be used as a novel risk-stratification tool to help identify older patients who would benefit from the most aggressive BP treatment goals, ultimately decreasing CVD events in this at-risk population. This will facilitate further studies that could eventually lead to the use of these techniques in clinical settings, allowing prescribers to easily and non-invasively identify older Veterans at the highest CVD risk and more easily assign optimal blood pressure targets to each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive BP targets | Experimental | Other: Blood pressure treatment algorithm<120 mmHg systolic) |
| Standard blood pressure targets | Active comparator | Other: Blood pressure treatment algorithm<140 mmHg systolic |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure treatment algorithmSingle 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. | Other | Intensive BP targets, Standard blood pressure targets |
Primary outcome
Load-dependent arterial stiffness measured with pulse wave velocity (m/s)
Time frame: 12 months
Load dependent stiffening is measured with ultrasound and tonometry and is the stiffness component due to elevated blood pressure increasing collagen fiber loading without an intrinsic change to the artery wall. The primary outcomes of load-dependent stiffness will be assessed at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy.
Structural arterial stiffness measured with pulse wave velocity (m/s)
Time frame: 12 months
Structural stiffening is measured with ultrasound and tonometry and is the stiffness component due to growth (eg. intima-media thickening) and remodeling (eg. elastin fragmentation, collagen accumulation) of the arterial wall. The primary outcomes of structural arterial stiffness will be assessed at baseline and after 3, 6 and 12 months of guideline-based antihypertensive therapy.
2 secondary outcomes
Total arterial stiffness measured with pulse wave velocity (m/s)
Time frame: 12 months
Brachial blood pressure
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Gepner principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure treatment algorithm in people with Hypertension and Vascular Stiffness, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Gepner ((608) 256-1901 ext. 12984, adam.gepner@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Load-dependent arterial stiffness measured with pulse wave velocity (m/s) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.