Cardiovascular DiseaseV-EXTRA-CVDNCT04545489
A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention
A study testing Intervention group in people with Cardiovascular Disease and Hypertension, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
The VA is the largest single provider of HIV care in the US and Veterans with HIV use significantly more healthcare services and have a 1.5-2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The goal is to improve BP treatment for Veterans with HIV to reduce ASCVD risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Hypertension, Care Coordination
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Dec 2020to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age => 18 years
- Confirmed HIV+ diagnosis
- Undetectable HIV viral load: defined as the most recent HIV viral load < 200 copies/mL, checked within the past 18 months (assessed via chart abstraction)
- Hypertension: defined as the average of 4 most recent outpatient BP measurements in the last 18 months to show systolic BP 130 and/or diastolic 90 mmHg (assessed via chart abstraction)
- Veteran at one of the sites participating in the study
- Regular access to a computer, tablet or smart phone device with internet.
Who cannot join
- Severely hearing or speech impaired, or other disability that would limit participation
- In a nursing home at baseline and/or any long-term care facility. Individuals will be censored at the point of entering nursing home care
- In-patient psychiatric care
- Diagnosis of dementia or active psychosis
- Terminal illness with life expectancy < 4 months (ex. Metastatic cancer, Hospice care)
- Recent (<90day) hospitalization for coronary artery bypass surgery (CABG), myocardial infarction (MI), stroke)
Show all 9Show fewer
- Pregnant, breast-feeding, or planning a pregnancy during the study period
- Planning to move out of the area in the next 12 months.
- No reliable access to telephone services
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention (V-EXTRA-CVD)
The VA is the largest single provider of HIV care in the US and Veterans with HIV use significantly more healthcare services and have a 1.5-2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The goal is to improve BP treatment for Veterans with HIV to reduce ASCVD risk. Within a randomized controlled trial (RCT), the investigators hypothesize that the VA adapted nurse-led intervention will result in a clinically significant 6 millimeters of mercury (mmHg) reduction in systolic blood pressure (SBP) over 12 months compared to those receiving enhanced education only. The study is innovative because of the use of stakeholder-engaged design process, multi-component nurse-led intervention, and VA Video Connect (VVC) to monitor CVD risk factors. The project meets VA strategic priorities including: 1) greater choice for Veterans; 2) improve timeliness of services; 3) focus more resources more efficiently (strengthen foundational services in VA). If shown to be effective, this intervention will have substantial impact among high-risk Veterans, potentially reducing ASCVD events by more than a quarter.
Read the detailed description
Background: The VA is the largest provider of HIV care in the United States. The ~31,000 Veterans with HIV use significantly more healthcare and have up to 2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The HIV treatment cascade model includes care steps; once people obtain remission, providers should focus on preventing ASCVD. The investigators will extend the HIV treatment cascade and focus on reducing ASCVD risk among people with HIV. Veterans with HIV have low perceived risk for ASCVD and uptake of guideline-based treatment for BP is low.
Significance/Impact: The proposed intervention has the potential to reduce ASCVD events in this population by more than a quarter and meet VA strategic priorities of: 1) improve timeliness of services; 2) focus resources more efficiently as well as address health systems research (HSR) research priorities: 1) patient centered care, care management, and health promotion; 2) healthcare access; 3) aging; 4) virtual care.
Innovation: The study is innovative: Cascade Model. By leveraging the HIV treatment cascade model, the investigators will create a pathway for ASCVD risk reduction to be added into widespread quality improvement initiatives. Stakeholder-engaged design process. The investigators will employ stakeholder-engaged research methods to ensure the intervention meets the needs of patients and healthcare providers. Multi-component nurse-led intervention. While each of the components of the intervention have an evidence base, they have not been tested together in an HIV context. Telehealth. The investigators will use VA Video Connect (VVC) to monitor CVD risk factors.
Specific Aims: Aim 1a: Conduct qualitative interviews with Veterans and healthcare providers to ascertain perceptions regarding HIV and CVD risk reductions to inform intervention adaptation.
Aim 1b: Adapt the intervention to the VA HIV clinic context with key stakeholder input.
Aim 2: Evaluate the 12-month efficacy of a nurse intervention to improve systolic blood pressure in Veterans with HIV. Hypothesis: The investigators hypothesize that the intervention will result in a clinically significant 6mmHg reduction in SBP over 12 months compared to those receiving [enhanced education + usual care] only. Aim 3: Conduct an evaluation of the prevention nurse intervention. Exploratory aim: If effective, [the investigators will conduct a budget impact analysis] and simulate 10-year cost-effectiveness of the nurse intervention.
Methodology: The investigators will conduct qualitative interviews with care team and Veterans to adapt the intervention in an iterative design process. The investigators will then conduct a RCT to evaluate an intervention to reduce ASCVD risk. The study will be conducted in 3 clinics among HIV+ Veterans (n=300) on suppressive antiretroviral therapy (ART) with confirmed SBP >140 mmHg, stratified by clinic site and randomized 1:1 to intervention vs. education control. The intervention will involve 4 evidence-based components based on the investigators' prior studies and adapted to Veterans with HIV: (1) nurse-led care coordination, (2) nurse-managed medication and adherence support (3) home BP monitoring, and (4) administered VA Video Connect (VVC). The education control will receive enhanced education and usual care. Primary outcome: difference in 12-month systolic BP in the intervention arm vs control. Secondary outcome: 12-month difference in non-HDL cholesterol. The investigators will use a mixed-methods design to evaluate fidelity, dose delivered/received, reach, recruitment, and context of the intervention.
Implementation/Next Steps: The investigators designed the intervention with downstream implementation in view. This includes: a fully remote delivery of the intervention to facilitate access and widespread implementation, and guidance for selection of nurses with education / experience levels that match those of health coaches delivering interventions within the VA. The investigators will work with operational partners from the Office of Connected Care and Office of HIV/AIDS care regarding implementation plans. The investigators will disseminate a clinical program, including scripts, and description of all intervention processes, to facilitate implementation within the VA.
- Being tested
- Intervention group, Education control group
- Keywords
- HIV, Cardiovascular Disease, Medication Management, Care Coordination
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
Education control groupBehavioural
This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months. Receives: Behavioral: Intervention group |
| Education control group | Active comparator | Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction. Receives: Behavioral: Education control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Measured: Baseline
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Measured: 4 months
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Measured: 8 months
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Measured: 12 months
Secondary outcomes (4)
Non-HDL Cholesterol
Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Measured: Baseline
Non-HDL Cholesterol
Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Measured: 4 months
Non-HDL Cholesterol
Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Measured: 8 months
Non-HDL Cholesterol
Non-HDL Cholesterol will be calculated by "Total Cholesterol - HDL Cholesterol" and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
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 Sep 2020
- Study start1 Dec 2020
- Primary completion1 Oct 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hayden B Bosworth, PhD, Principal investigator, Durham VA Medical Center, Durham, NCPuja Van Epps, MD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545489
- Sponsor's protocol ID
- IIR 19-418
- Acronym
- V-EXTRA-CVD
- Status last verified
- Oct 2025
- First submitted
- 3 Sep 2020
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication and study results will be available on Clinical Trials.gov within 1 year of the final follow-up with last study participant. A local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI) prior to distribution. Data will be provided to requester in electronic form. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access.
Publications
Schexnayder J, Perry KR, Sheahan K, Majette Elliott N, Subramaniam S, Strawbridge E, Webel AR, Bosworth HB, Gierisch JM. Team-Based Qualitative Rapid Analysis: Approach and Considerations for Conducting Developmental Formative Evaluation for Intervention Design. Qual Health Res. 2023 Jul;33(8-9):778-789. doi: 10.1177/10497323231167348. Epub 2023 Jun 6.
PubMed 37278662Musoke L, Bosworth HB, Dickson C, Gentry P, Strawbridge E, Subramaniam S, Gierisch J, Smith V, Woolson S, Pura J, Amutuhaire W, Naggie S, Schexnayder J, Hall K, Longenecker CT, Harris NM, Rogers C, Van Epps P; for V-EXTRA-CVD Group. A telehealth-delivered intervention to extend the veteran HIV treatment cascade for cardiovascular disease prevention: V-EXTRA-CVD study protocol for a randomized controlled trial. HIV Res Clin Pract. 2023 Dec;24(1):2261747. Epub 2023 Oct 6.
PubMed 37800987
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-led Intervention to Extend the Veteran HIV Treatment Cascade for Cardiovascular Disease Prevention (V-EXTRA-CVD)
- ClinicalTrials.gov ID
- NCT04545489
- Acronym / sponsor ID
- V-EXTRA-CVD / IIR 19-418
- Keywords
- HIV, Cardiovascular Disease, Medication Management, Care Coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VA is the largest single provider of HIV care in the US and Veterans with HIV use significantly more healthcare services and have a 1.5-2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The goal is to improve BP treatment for Veterans with HIV to reduce ASCVD risk. Within a randomized controlled trial (RCT), the investigators hypothesize that the VA adapted nurse-led intervention will result in a clinically significant 6 millimeters of mercury (mmHg) reduction in systolic blood pressure (SBP) over 12 months compared to those receiving enhanced education only. The study is innovative because of the use of stakeholder-engaged design process, multi-component nurse-led intervention, and VA Video Connect (VVC) to monitor CVD risk factors. The project meets VA strategic priorities including: 1) greater choice for Veterans; 2) improve timeliness of services; 3) focus more resources more efficiently (strengthen foundational services in VA). If shown to be effective, this intervention will have substantial impact among high-risk Veterans, potentially reducing ASCVD events by more than a quarter.
Detailed description
Background: The VA is the largest provider of HIV care in the United States. The ~31,000 Veterans with HIV use significantly more healthcare and have up to 2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The HIV treatment cascade model includes care steps; once people obtain remission, providers should focus on preventing ASCVD. The investigators will extend the HIV treatment cascade and focus on reducing ASCVD risk among people with HIV. Veterans with HIV have low perceived risk for ASCVD and uptake of guideline-based treatment for BP is low.
Significance/Impact: The proposed intervention has the potential to reduce ASCVD events in this population by more than a quarter and meet VA strategic priorities of: 1) improve timeliness of services; 2) focus resources more efficiently as well as address health systems research (HSR) research priorities: 1) patient centered care, care management, and health promotion; 2) healthcare access; 3) aging; 4) virtual care.
Innovation: The study is innovative: Cascade Model. By leveraging the HIV treatment cascade model, the investigators will create a pathway for ASCVD risk reduction to be added into widespread quality improvement initiatives. Stakeholder-engaged design process. The investigators will employ stakeholder-engaged research methods to ensure the intervention meets the needs of patients and healthcare providers. Multi-component nurse-led intervention. While each of the components of the intervention have an evidence base, they have not been tested together in an HIV context. Telehealth. The investigators will use VA Video Connect (VVC) to monitor CVD risk factors.
Specific Aims: Aim 1a: Conduct qualitative interviews with Veterans and healthcare providers to ascertain perceptions regarding HIV and CVD risk reductions to inform intervention adaptation.
Aim 1b: Adapt the intervention to the VA HIV clinic context with key stakeholder input.
Aim 2: Evaluate the 12-month efficacy of a nurse intervention to improve systolic blood pressure in Veterans with HIV. Hypothesis: The investigators hypothesize that the intervention will result in a clinically significant 6mmHg reduction in SBP over 12 months compared to those receiving [enhanced education + usual care] only. Aim 3: Conduct an evaluation of the prevention nurse intervention. Exploratory aim: If effective, [the investigators will conduct a budget impact analysis] and simulate 10-year cost-effectiveness of the nurse intervention.
Methodology: The investigators will conduct qualitative interviews with care team and Veterans to adapt the intervention in an iterative design process. The investigators will then conduct a RCT to evaluate an intervention to reduce ASCVD risk. The study will be conducted in 3 clinics among HIV+ Veterans (n=300) on suppressive antiretroviral therapy (ART) with confirmed SBP >140 mmHg, stratified by clinic site and randomized 1:1 to intervention vs. education control. The intervention will involve 4 evidence-based components based on the investigators' prior studies and adapted to Veterans with HIV: (1) nurse-led care coordination, (2) nurse-managed medication and adherence support (3) home BP monitoring, and (4) administered VA Video Connect (VVC). The education control will receive enhanced education and usual care. Primary outcome: difference in 12-month systolic BP in the intervention arm vs control. Secondary outcome: 12-month difference in non-HDL cholesterol. The investigators will use a mixed-methods design to evaluate fidelity, dose delivered/received, reach, recruitment, and context of the intervention.
Implementation/Next Steps: The investigators designed the intervention with downstream implementation in view. This includes: a fully remote delivery of the intervention to facilitate access and widespread implementation, and guidance for selection of nurses with education / experience levels that match those of health coaches delivering interventions within the VA. The investigators will work with operational partners from the Office of Connected Care and Office of HIV/AIDS care regarding implementation plans. The investigators will disseminate a clinical program, including scripts, and description of all intervention processes, to facilitate implementation within the VA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupParticipants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months. |
| Education control group | Active comparator | Behavioral: Education control groupParticipants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age => 18 years
- Confirmed HIV+ diagnosis
- Undetectable HIV viral load: defined as the most recent HIV viral load < 200 copies/mL, checked within the past 18 months (assessed via chart abstraction)
- Hypertension: defined as the average of 4 most recent outpatient BP measurements in the last 18 months to show systolic BP 130 and/or diastolic 90 mmHg (assessed via chart abstraction)
- Veteran at one of the sites participating in the study
Key exclusion criteria (9 listed)
- Severely hearing or speech impaired, or other disability that would limit participation
- In a nursing home at baseline and/or any long-term care facility. Individuals will be censored at the point of entering nursing home care
- In-patient psychiatric care
- Diagnosis of dementia or active psychosis
- Terminal illness with life expectancy < 4 months (ex. Metastatic cancer, Hospice care)
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 |
|---|---|---|
| Intervention groupThis is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist) | Behavioural | Intervention group |
| Education control groupThis group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months. | Behavioural | Education control group |
Primary outcome
Mean Systolic Blood Pressure
Time frame: Baseline
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Mean Systolic Blood Pressure
Time frame: 4 months
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Mean Systolic Blood Pressure
Time frame: 8 months
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Mean Systolic Blood Pressure
Time frame: 12 months
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
4 secondary outcomes
Non-HDL Cholesterol
Time frame: Baseline
Non-HDL Cholesterol
Time frame: 4 months
Non-HDL Cholesterol
Time frame: 8 months
Non-HDL Cholesterol
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37278662Schexnayder J, Perry KR, Sheahan K, Majette Elliott N, Subramaniam S, Strawbridge E, Webel AR, Bosworth HB, Gierisch JM. Team-Based Qualitative Rapid Analysis: Approach and Considerations for Conducting Developmental Formative Evaluation for Intervention Design. Qual Health Res. 2023 Jul;33(8-9):778-789. doi: 10.1177/10497323231167348. Epub 2023 Jun 6.
- Results publication: PubMed 37800987Musoke L, Bosworth HB, Dickson C, Gentry P, Strawbridge E, Subramaniam S, Gierisch J, Smith V, Woolson S, Pura J, Amutuhaire W, Naggie S, Schexnayder J, Hall K, Longenecker CT, Harris NM, Rogers C, Van Epps P; for V-EXTRA-CVD Group. A telehealth-delivered intervention to extend the veteran HIV treatment cascade for cardiovascular disease prevention: V-EXTRA-CVD study protocol for a randomized controlled trial. HIV Res Clin Pract. 2023 Dec;24(1):2261747. Epub 2023 Oct 6.
- Individual participant dataSharing planned: Yes. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication and study results will be available on Clinical Trials.gov within 1 year of the final follow-up with last study participant. A local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI) prior to distribution. Data will be provided to requester in electronic form. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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. This study is not recruiting at the moment.
Hayden B Bosworth, PhD principal investigator
Durham VA Medical Center, Durham, NC
Puja Van Epps, MD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Cardiovascular Disease and Hypertension, run by VA Office of Research and Development at 4 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Systolic Blood Pressure (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545489, which also lists 2 linked publications.
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 30 Oct 2025.