Heart DiseasesNCT07745894
VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
A study testing Virtual Cardiac Rehabilitation and In-Person Cardiac Rehabilitation in people with Heart Diseases, run by Mayo Clinic at 3 sites in United States.
Trial summary
The purpose of this research is to compare health outcomes and participation between a virtual world cardiac rehabilitation (Destination Cardiac Rehab) program and the standard of care Center-based Cardiac Rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Virtual Cardiac Rehabilitation and In-Person Cardiac Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2026to Aug 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for CR according to Centers for Medicare \& Medicaid Services (CMS) guidelines:
- Myocardial infarction within the preceding 12 months
- Coronary artery bypass surgery
- Current stable angina (chest pain)
- Heart valve repair or replacement
- Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
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- Heart or heart-lung transplant
- Stable chronic heart failure
- Aged ≥18 years
- Basic Internet navigation skills
- Active email address
Who cannot join
- High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification103 given safety concern of unsupervised exercise:
- Sudden cardiac arrest survivor
- Receiving continuous inotropic support
- Presence of a mechanical circulatory support device
- Decompensated heart failure
- Symptomatic valvular heart disease
Show all 11Show fewer
- Uncontrolled angina
- Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia)
- Pregnant (due to associated hormonal and weight changes)
- Non-English-speaking
- Visual/hearing impairment or mental disability that would preclude independent use of the VW platform
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kolawole Olarinoye contact
United States3 sites
University of California
Irvine, California, 92697
Ashwini Erande
Nathan Wong, PhD
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Memrie Cochran, mcochran1@umc.edu
Michael Hall, MD
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Virtual World-based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
The purpose of this research is to compare health outcomes and participation between a virtual world cardiac rehabilitation (Destination Cardiac Rehab) program and the standard of care Center-based Cardiac Rehabilitation program. Destination Cardiac Rehab, developed with input from patients with heart disease and their caregivers, is a 3-D, interactive program offering an affordable telehealth option for cardiac rehabilitation (cardiac rehab) that can be done from home or any place that you can access the Internet with a computer.
- Conditions
- Heart Diseases
- Being tested
- Virtual Cardiac Rehabilitation, In-Person Cardiac Rehabilitation
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Cardiac RehabilitationOther
- Weekly Virtual Cardiac Rehabilitation Session
- Virtual Nurse Coaching Visit (frequency: weekly)
- Virtual Exercise Physiologist Visit (frequency: weekly)
- Self-Directed Exercise: 3 sessions per week
In-Person Cardiac RehabilitationOther
Participants will attend three in-person cardiac rehabilitation sessions per week, each including:
- Supervised exercise under the guidance of an Exercise Physiologist
- Educational components related to cardiac health and lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Virtual World-based Cardiac Rehabilitation | Experimental | Not described Receives: Other: Virtual Cardiac Rehabilitation |
| Control Arm | Active comparator | Not described Receives: Other: In-Person Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LE8 composite score
Life's Essential 8 score is a composite cardiovascular health (CVH) score developed by the American Heart Association (AHA) to quantify and track an individual's heart- and brain-health based on eight key lifestyle behaviors and clinical health factors (healthy diet, physical activity, nicotine exposure, sleep health, body mass index, lipids, glucose and blood pressure). The score ranges from 0 to 100 points, with higher scores indicating better overall cardiovascular health.
Interpretation of the composite score usually follows these general categories:
0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health
Measured: Baseline, 3 Months, 6 Months
Secondary outcomes (3)
Number of CV-related hospital readmissions
Number of CV-related hospital readmissions will be defined as the total number of participants readmitted to the hospital for a cardiovascular-related issue.
Measured: 3 Months, 6 Months
Number of Deaths
Number of deaths will be defined as the total number of participants who die, regardless of cause
Measured: 3 Months, 6 Months
Number of CV Deaths
Number of CV deaths will be defined as the total number of participants who die due to cardiovascular (CV)-related causes.
Measured: 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, LaPrincess C. Brewer, Mayo Clinic
- Investigators
- LaPrincess Brewer, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745894
- Sponsor's protocol ID
- 25-008267
- Other IDs
- 1R01LM014760-01
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual World-based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
- ClinicalTrials.gov ID
- NCT07745894
- Acronym / sponsor ID
- 25-008267
- Conditions
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 4 Aug 2026 (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.
The purpose of this research is to compare health outcomes and participation between a virtual world cardiac rehabilitation (Destination Cardiac Rehab) program and the standard of care Center-based Cardiac Rehabilitation program. Destination Cardiac Rehab, developed with input from patients with heart disease and their caregivers, is a 3-D, interactive program offering an affordable telehealth option for cardiac rehabilitation (cardiac rehab) that can be done from home or any place that you can access the Internet with a computer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual World-based Cardiac Rehabilitation | Experimental | Other: Virtual Cardiac Rehabilitation |
| Control Arm | Active comparator | Other: In-Person Cardiac Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Indication for CR according to Centers for Medicare \& Medicaid Services (CMS) guidelines:
- Aged ≥18 years
- Basic Internet navigation skills
- Active email address
Key exclusion criteria (11 listed)
- High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification103 given safety concern of unsupervised exercise:
- Pregnant (due to associated hormonal and weight changes)
- Non-English-speaking
- Visual/hearing impairment or mental disability that would preclude independent use of the VW platform
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 |
|---|---|---|
| Virtual Cardiac Rehabilitation* Weekly Virtual Cardiac Rehabilitation Session * Virtual Nurse Coaching Visit (frequency: weekly) * Virtual Exercise Physiologist Visit (frequency: weekly) * Self-Directed Exercise: 3 sessions per week | Other | Virtual World-based Cardiac Rehabilitation |
| In-Person Cardiac RehabilitationParticipants will attend three in-person cardiac rehabilitation sessions per week, each including: * Supervised exercise under the guidance of an Exercise Physiologist * Educational components related to cardiac health and lifestyle | Other | Control Arm |
Primary outcome
Change in LE8 composite score
Time frame: Baseline, 3 Months, 6 Months
Life's Essential 8 score is a composite cardiovascular health (CVH) score developed by the American Heart Association (AHA) to quantify and track an individual's heart- and brain-health based on eight key lifestyle behaviors and clinical health factors (healthy diet, physical activity, nicotine exposure, sleep health, body mass index, lipids, glucose and blood pressure). The score ranges from 0 to 100 points, with higher scores indicating better overall cardiovascular health. Interpretation of the composite score usually follows these general categories: 0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health
3 secondary outcomes
Number of CV-related hospital readmissions
Time frame: 3 Months, 6 Months
Number of Deaths
Time frame: 3 Months, 6 Months
Number of CV Deaths
Time frame: 3 Months, 6 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 28 Oct 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.
Kolawole Olarinoye contact
LaPrincess Brewer, MD, MPH principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Cardiac Rehabilitation and In-Person Cardiac Rehabilitation in people with Heart Diseases, run by Mayo Clinic 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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 Oct 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 Ashton Krogman (507-266-2087, krogman.ashton@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LE8 composite score (time frame: Baseline, 3 Months, 6 Months). 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 28 Oct 2026.