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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title Home-Based Cardiac Rehabilitation for Patients With Heart Failure
ClinicalTrials.gov ID: NCT06479876
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Roll-in Phase
- Stage C HF (NYHA Class I-III) AND
- Discharged from a HF hospitalization OR
- Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
- Scheduled for appointment in a cardiology clinic with a KCCQ-SS \<75
You likely can't join if
- Roll-in Phase
- Unwilling or unable to provide informed consent for participation in the RCT
- 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...
- 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...
- 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...
- Age \< 18 years
See the full eligibility criteria
- Roll-in Phase
- Stage C HF (NYHA Class I-III) AND
- Discharged from a HF hospitalization OR
- Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
- Scheduled for appointment in a cardiology clinic with a KCCQ-SS \<75
- Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase assigned by chance Controlled Trial (beyond roll-in phase) 1\. Willingness to continue and participate in the study visits...
- Roll-in Phase
- Unwilling or unable to provide informed consent for participation in the RCT
- 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...
- 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...
- 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.
- Age \< 18 years
- Stage D HF (advanced HF under evaluation for LVAD or transplant)
- NYHA class IV symptoms
- Congenital heart disease
- Pregnant
- Group 1 pulmonary hypertension
- Moderate-severe or severe (\> 3+) mitral or aortic valvular disease
- 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)
- Planned surgery within 3 months
- 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)
- Treating provider or study team physician indicates that participation in the RCT would be unsafe
- Participation in any ongoing assigned by chance trial that has not completed follow-up assigned by chance Controlled Trial (beyond roll-in phase)
- 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...
- Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.