Cardiovascular DiseaseMVP-ROARNCT04178122
Million Veteran Program Return of Actionable Results
A study testing Result disclosure in people with Cardiovascular Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of the Million Veteran Program- Return of Actionable Results (MVP-ROAR) Study is to develop a process to return medically actionable genetic results to living MVP participants nationwide and to determine the impact of doing so on medical management and outcomes and Veteran quality of life. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Result disclosure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to 8 Sep 2024
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living enrollee in MVP
- Is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in MVP genotype data
Who cannot join
- Previously underwent genetic testing for the condition of interest
- Is incarcerated
- Is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
The purpose of the Million Veteran Program- Return of Actionable Results (MVP-ROAR) Study is to develop a process to return medically actionable genetic results to living MVP participants nationwide and to determine the impact of doing so on medical management and outcomes and Veteran quality of life.
Read the detailed description
The Million Veteran Program - Return of Actionable Results (MVP-ROAR) Study is a randomized controlled trial of immediate vs. delayed (after 6 months) return of medically actionable, clinically confirmed genetic testing results. MVP participants with a medically actionable variant in their MVP chip genotype data will be contacted and offered the opportunity to receive clinical confirmation of this result through a research protocol. First, a non-randomized pilot trial will be conducted among 10 eligible MVP participants, followed by a randomized controlled trial of immediate vs. delayed clinical confirmation and reporting, delivered to participants nationwide via telegenetic counseling.
Three hypotheses will be tested:
Hypothesis 1 (LDL-C change): LDL-C reduction after 6 months will be greater in the Immediate Results arm compared to the Delayed Results arm (primary outcome) Hypothesis 2 (LDL-C target): The proportion of participants meeting clinically significant LDL-C targets (<100mg/dL for primary prevention and <70 mg/dL for secondary prevention) at 6 months will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome) Hypothesis 3 (Pharmacotherapy): the proportion of participants with an intensification of lipid-lowering pharmacotherapy will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome)
- Conditions
- Cardiovascular Disease
- Being tested
- Result disclosure
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Result disclosureGenetic
Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Results | Experimental | Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization. Receives: Genetic: Result disclosure |
| Delayed Results | Experimental | Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization. Receives: Genetic: Result disclosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C Change
Change in LDL-C after 6 months.
Measured: 6 months
Secondary outcomes (2)
LDL-C Target
The number of participants meeting clinically significant LDL-C targets (< 100mg/dL for primary prevention and <70 mg/dL for secondary prevention) at 6 months.
Measured: 6 months
Pharmacotherapy
The number of participants with an intensification of lipid-lowering pharmacotherapy, a composite outcome including prescription of new monotherapy, dose escalation of existing pharmacotherapy, and addition of one or more medications to existing pharmacotherapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start27 Feb 2020
- Primary completion8 Sep 2024
- Study completion8 Sep 2024
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jason L Vassy, MD MPH, Study chair, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178122
- Sponsor's protocol ID
- MVP030
- Acronym
- MVP-ROAR
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2019
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual-level trial data through a data repository housed on a secure VA server and accessible only to outside investigators with IRB and other regulatory approvals. MVP ROAR Study data will also be stored in the VA MVP Central Database.
Publications
Vassy JL, Brunette CA, Yi T, Assimes TL, Christensen KD, Knowles JW, Sturm AC, Sun YV, Alexander N, Cardellino MP, Harrison A, Gerety HL, Pyatt M, Vered R, Wilson PWF, Natarajan P, Whitbourne SB, Gaziano JM, Muralidhar S, Danowski ME; Veterans Affairs Million Veteran Program. Opportunistic Genomic Screening for Familial Hypercholesterolemia to Improve Low-Density Lipoprotein Cholesterol: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2549664. doi: 10.1001/jamanetworkopen.2025.49664.
PubMed 41511773Vassy JL, Brunette CA, Yi T, Harrison A, Cardellino MP, Assimes TL, Christensen KD, Devineni P, Gaziano JM, Gong X, Hui Q, Knowles JW, Muralidhar S, Natarajan P, Pyarajan S, Sears MG, Shi Y, Sturm AC, Whitbourne SB, Sun YV, Danowski ME; Million Veteran Program. Design and pilot results from the Million Veteran Program Return Of Actionable Results (MVP-ROAR) Study. Am Heart J. 2024 Oct;276:99-109. doi: 10.1016/j.ahj.2024.04.021. Epub 2024 May 17.
PubMed 38762090
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Million Veteran Program Return of Actionable Results
- ClinicalTrials.gov ID
- NCT04178122
- Acronym / sponsor ID
- MVP-ROAR / MVP030
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 8 Sep 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 16 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 purpose of the Million Veteran Program- Return of Actionable Results (MVP-ROAR) Study is to develop a process to return medically actionable genetic results to living MVP participants nationwide and to determine the impact of doing so on medical management and outcomes and Veteran quality of life.
Detailed description
The Million Veteran Program - Return of Actionable Results (MVP-ROAR) Study is a randomized controlled trial of immediate vs. delayed (after 6 months) return of medically actionable, clinically confirmed genetic testing results. MVP participants with a medically actionable variant in their MVP chip genotype data will be contacted and offered the opportunity to receive clinical confirmation of this result through a research protocol. First, a non-randomized pilot trial will be conducted among 10 eligible MVP participants, followed by a randomized controlled trial of immediate vs. delayed clinical confirmation and reporting, delivered to participants nationwide via telegenetic counseling.
Three hypotheses will be tested:
Hypothesis 1 (LDL-C change): LDL-C reduction after 6 months will be greater in the Immediate Results arm compared to the Delayed Results arm (primary outcome) Hypothesis 2 (LDL-C target): The proportion of participants meeting clinically significant LDL-C targets (<100mg/dL for primary prevention and <70 mg/dL for secondary prevention) at 6 months will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome) Hypothesis 3 (Pharmacotherapy): the proportion of participants with an intensification of lipid-lowering pharmacotherapy will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Results | Experimental | Genetic: Result disclosureParticipants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization. |
| Delayed Results | Experimental | Genetic: Result disclosureParticipants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Living enrollee in MVP
- Is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in MVP genotype data
Key exclusion criteria (3 listed)
- Previously underwent genetic testing for the condition of interest
- Is incarcerated
- Is pregnant
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 |
|---|---|---|
| Result disclosureDisclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session. | Genetic | Delayed Results, Immediate Results |
Primary outcome
LDL-C Change
Time frame: 6 months
Change in LDL-C after 6 months.
2 secondary outcomes
LDL-C Target
Time frame: 6 months
Pharmacotherapy
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41511773Vassy JL, Brunette CA, Yi T, Assimes TL, Christensen KD, Knowles JW, Sturm AC, Sun YV, Alexander N, Cardellino MP, Harrison A, Gerety HL, Pyatt M, Vered R, Wilson PWF, Natarajan P, Whitbourne SB, Gaziano JM, Muralidhar S, Danowski ME; Veterans Affairs Million Veteran Program. Opportunistic Genomic Screening for Familial Hypercholesterolemia to Improve Low-Density Lipoprotein Cholesterol: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2549664. doi: 10.1001/jamanetworkopen.2025.49664.
- Derived from this study: PubMed 38762090Vassy JL, Brunette CA, Yi T, Harrison A, Cardellino MP, Assimes TL, Christensen KD, Devineni P, Gaziano JM, Gong X, Hui Q, Knowles JW, Muralidhar S, Natarajan P, Pyarajan S, Sears MG, Shi Y, Sturm AC, Whitbourne SB, Sun YV, Danowski ME; Million Veteran Program. Design and pilot results from the Million Veteran Program Return Of Actionable Results (MVP-ROAR) Study. Am Heart J. 2024 Oct;276:99-109. doi: 10.1016/j.ahj.2024.04.021. Epub 2024 May 17.
- Individual participant dataSharing planned: Yes. We will share de-identified individual-level trial data through a data repository housed on a secure VA server and accessible only to outside investigators with IRB and other regulatory approvals. MVP ROAR Study data will also be stored in the VA MVP Central Database.
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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. This study is not recruiting at the moment.
Jason L Vassy, MD MPH study chair
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Result disclosure in people with Cardiovascular Disease, run by VA Office of Research and Development at 1 site 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 2 inclusion and 3 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 16 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 1 site 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 16 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?
LDL-C Change (time frame: 6 months). 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 NCT04178122, 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 16 Oct 2025.