NCT04178122 (MVP-ROAR) is a NA clinical trial of Result disclosure in Cardiovascular Disease, sponsored by VA Office of Research and Development.

Who is sponsoring NCT04178122?

NCT04178122 is sponsored by VA Office of Research and Development.

What drugs are being tested in NCT04178122?

Interventions in NCT04178122: Result disclosure.

What condition does NCT04178122 study?

NCT04178122 studies Cardiovascular Disease.

Is NCT04178122 still recruiting?

NCT04178122 is currently completed. Last updated 16 October 2025.

Are results published for NCT04178122?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-16 · How we verify

NCT04178122: MVP-ROAR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Million Veteran Program Return of Actionable Results

Completed NA Results posted Last updated 16 October 2025

What this trial tests

NA trial testing Result disclosure in Cardiovascular Disease in 112 participants. Completed in 8 September 2024.

Timeline

27 February 2020

Primary endpoint
8 September 2024

8 September 2024

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	112
Start date	27 February 2020
Primary completion	8 September 2024
Estimated completion	8 September 2024
Sites	1 location across United States

Drugs / interventions tested

Result disclosure

Conditions studied

Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

22 and older, any sex, with Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

LDL-C Change Primary · 6 months

Change in LDL-C after 6 months.

Group	Value	95% CI
Immediate Results	-8.0	± 32.3
Delayed Results	2.4	± 28.9

LDL-C Target Secondary · 6 months

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.

Group	Value	95% CI
Immediate Results	15
Delayed Results	14

Pharmacotherapy Secondary · 6 months

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.

Group	Value	95% CI
Immediate Results	11
Delayed Results	5

Cascade Testing Secondary · 6 months

The number of first-degree relatives having undergone genetic testing at 6 months.

Group	Value	95% CI
Immediate Results	3
Delayed Results	0

Lifestyle Behaviors Secondary · 6 months

The number of participants reporting healthy lifestyle behaviors (smoking, physical activity, and saturated fat intake) at 6 months, measured by questionnaire responses.

6-month physical activity

Group	Value	95% CI
Immediate Results	30
Delayed Results	27
Immediate Results	3
Delayed Results	4
Immediate Results	4
Delayed Results	6
Immediate Results	6
Delayed Results	1

6-month saturated fat consumption

Group	Value	95% CI
Immediate Results	23
Delayed Results	28
Immediate Results	2
Delayed Results	0
Immediate Results	1
Delayed Results	3
Immediate Results	3
Delayed Results	0

Quality of Life (Veterans RAND Survey) Secondary · 6 months

Quality of life, measured by the Veterans RAND (distributed by RAND Corporation) 12-item Health Survey (VR-12). Items are scored using an algorithm and summarized into two scores (Physical Component Score and a Mental Component Score) ranging from 0-100, with a higher score indicating better health.

Physical component: baseline

Group	Value	95% CI
Immediate Results	38.32	± 11.05
Delayed Results	39.08	± 14.47

Physical component: 6-month

Group	Value	95% CI
Immediate Results	39.10	± 11.44
Delayed Results	40.58	± 14.14

Physical component: change

Group	Value	95% CI
Immediate Results	0.78	± 4.45
Delayed Results	1.5	± 4.83

Mental component: baseline

Group	Value	95% CI
Immediate Results	47.78	± 13.98
Delayed Results	49.69	± 12.98

Mental component: 6-month

Group	Value	95% CI
Immediate Results	47.38	± 14.29
Delayed Results	49.99	± 12.98

Mental component: change

Group	Value	95% CI
Immediate Results	-0.403	± 6.29
Delayed Results	0.31	± 4.66

Medication Adherence Secondary · 6 months

Medication adherence at 6 months, measured by the Beliefs About Medicines Questionnaire (BMQ).

Doctors use too many medications

Group	Value	95% CI
Immediate Results	8
Delayed Results	6
Immediate Results	24
Delayed Results	14
Immediate Results	12
Delayed Results	18
Immediate Results	1
Delayed Results	0

People who take medicines should stop their treatment every now and then

Group	Value	95% CI
Immediate Results	0
Delayed Results	0
Immediate Results	3
Delayed Results	0
Immediate Results	30
Delayed Results	32
Immediate Results	16
Delayed Results	10

If doctors have more time with patients they would prescribe fewer medicines

Group	Value	95% CI
Immediate Results	6
Delayed Results	2
Immediate Results	20
Delayed Results	18
Immediate Results	10
Delayed Results	15
Immediate Results	3
Delayed Results	1

Doctors place too much trust in medicines

Group	Value	95% CI
Immediate Results	7
Delayed Results	3
Immediate Results	22
Delayed Results	17
Immediate Results	12
Delayed Results	15
Immediate Results	3
Delayed Results	0

Medicines do more harm than good

Group	Value	95% CI
Immediate Results	2
Delayed Results	1
Immediate Results	6
Delayed Results	3
Immediate Results	24
Delayed Results	25
Immediate Results	10
Delayed Results	9

Most medicines are addictive

Group	Value	95% CI
Immediate Results	1
Delayed Results	1
Immediate Results	6
Delayed Results	5
Immediate Results	33
Delayed Results	32
Immediate Results	6
Delayed Results	6

All medicines are poisons

Group	Value	95% CI
Immediate Results	1
Delayed Results	0
Immediate Results	0
Delayed Results	0
Immediate Results	34
Delayed Results	28
Immediate Results	14
Delayed Results	16

Natural remedies are safer than medicines

Group	Value	95% CI
Immediate Results	2
Delayed Results	2
Immediate Results	11
Delayed Results	5
Immediate Results	14
Delayed Results	20
Immediate Results	7
Delayed Results	3

Smoking Status Secondary · 6-month

6-month smoking status

Group	Value	95% CI
Immediate Results	15
Delayed Results	23
Immediate Results	30
Delayed Results	16
Immediate Results	1
Delayed Results	2
Immediate Results	4
Delayed Results	3

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Design and pilot results from the Million Veteran Program Return Of Actionable Results (MVP-ROAR) Study.
Vassy JL, Brunette CA, Yi T, Harrison A, et al · · 2024 · cited 3× · PMID 38762090 · DOI 10.1016/j.ahj.2024.04.021
Opportunistic Genomic Screening for Familial Hypercholesterolemia to Improve Low-Density Lipoprotein Cholesterol: A Randomized Clinical Trial.
Vassy JL, Brunette CA, Yi T, Assimes TL, et al · · 2026 · PMID 41511773 · DOI 10.1001/jamanetworkopen.2025.49664

Verify or expand the search:

Other recruiting trials for Cardiovascular Disease

Currently open trials in the same condition.

NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07293260 — Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial · Phase 3 · recruiting
NCT07497932 — Nutritional Effects in Cardiovascular Surgery · NA · recruiting
NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients · Phase 4 · recruiting
NCT06485700 — Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) · NA · recruiting

Other VA Office of Research and Development trials

Trials by the same sponsor.

NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04178122 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 16 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04178122.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing