NCT06479876 Home-Based Cardiac Rehabilitation for Patients With Heart Failure
| NCT ID | NCT06479876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-08-05 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.
Eligibility Criteria
Inclusion Criteria Roll-in Phase 1. Stage C HF (NYHA Class I-III) AND 1. Discharged from a HF hospitalization OR 2. Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR 3. Scheduled for appointment in a cardiology clinic with a KCCQ-SS \<75 2. Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase Randomized Controlled Trial (beyond roll-in phase) 1\. Willingness to continue and participate in the study visits and other study activities required for the RCT Exclusion Criteria Roll-in Phase 1. Unwilling or unable to provide informed consent for participation in the RCT 2. Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home 3. If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment. 4. History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient. 5. Age \< 18 years 6. Stage D HF (advanced HF under evaluation for LVAD or transplant) 7. NYHA class IV symptoms 8. Congenital heart disease 9. Pregnant 10. Group 1 pulmonary hypertension 11. Moderate-severe or severe (\> 3+) mitral or aortic valvular disease 12. Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia) 13. Planned surgery within 3 months 14. Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living) 15. Treating provider or study team physician indicates that participation in the RCT would be unsafe 16. Participation in any ongoing randomized trial that has not completed follow-up Randomized Controlled Trial (beyond roll-in phase) 1. Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device \>9 hours/day for at least 1 day. 2. Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.
Contact & Investigator
Brian R Lindman, MD, MSCI
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT06479876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06479876 currently recruiting?
Yes, NCT06479876 is actively recruiting participants. Contact the research team at bassim.el-sabawi@vumc.org for enrollment information.
Where is the NCT06479876 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06479876 clinical trial?
NCT06479876 is sponsored by Vanderbilt University Medical Center. The principal investigator is Brian R Lindman, MD, MSCI at Vanderbilt University Medical Center. The trial plans to enroll 100 participants.
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