Nashville, TNNCT06479876Now EnrollingIRB Ready

Heart Failure With Preserved Ejection Fraction Clinical Trial in Nashville, TN

Access cutting-edge heart failure with preserved ejection fraction treatment through this clinical trial at a research site in Nashville. Study-provided care at no cost to qualified participants.

Sponsored by Vanderbilt University Medical Center

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Expert Care in Nashville

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related heart failure with preserved ejection fraction treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Nashville

    Convenient for TN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Nashville site if eligible
  4. 4Begin participation

About This Heart Failure With Preserved Ejection Fraction Study in Nashville

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.

Sponsor: Vanderbilt University Medical Center

Who Can Participate

Inclusion 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 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
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 without it being needed in the home
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.
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
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 randomized trial that has not completed follow-up Randomized 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 device ³10 hours/day for 3 days and also wear the ActiGraph device \>9 hours/day for at least 1 day.
Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Nashville?

Yes, this clinical trial (NCT06479876) has an active research site in Nashville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure With Preserved Ejection Fraction Treatment Options in Nashville, TN

If you're searching for heart failure with preserved ejection fraction treatment options in Nashville, TN, this clinical trial (NCT06479876) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Nashville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure with preserved ejection fraction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure with preserved ejection fraction clinical trials near you to find additional studies recruiting in your area.

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