Heart Disease Trial, Recruiting NCT06479876 Sponsor: Vanderbilt University Medical Center Condition: Heart Disease
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Heart Disease Trial, Recruiting

NCT06479876
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed with Stage C heart failure with symptoms ranging from mild to moderate (NYHA Class I–III), who have recently been discharged from a hospital stay due to heart failure, OR have an upcoming cardiology appointment and have been hospitalised for heart failure in the past 12 months, OR have an upcoming cardiology appointment and have a low score on a heart failure quality-of-life questionnaire (confirm with trial site)
  • People who already receive ongoing heart failure care at Vanderbilt University Medical Center (VUMC), including at least one visit before the study begins
  • People who are willing to continue attending study visits and take part in all study activities required for the main trial phase

Who may not be able to join:

  • People who are unwilling or unable to give informed consent to participate
  • People who use a wheelchair all or most of the time, both inside and outside the home (occasional wheelchair use for things like navigating a hospital or a parking lot transfer is acceptable)
  • People who use a walker or cane all or most of the time AND who score 2 or lower on a brief memory/thinking test, OR who cannot independently complete 2 sit-to-stand movements from a chair, OR who are assessed as being at high risk of falling during the baseline visit
  • People who have had a pattern of falls in the last 6 months suggesting balance or stability problems (a single, explainable fall with no injury would not necessarily exclude someone — confirm with trial site)
  • People under 18 years of age
  • People with Stage D (advanced) heart failure who are being assessed for a heart pump device (LVAD) or a heart transplant
  • People with the most severe heart failure symptoms (NYHA Class IV)
  • People with heart defects present from birth (congenital heart disease)
  • People who are pregnant
  • People with a specific type of pulmonary hypertension known as Group 1
  • People with moderate-severe or severe disease affecting the mitral or aortic heart valves
  • People with physical or mental health conditions that would prevent them from using the study tools or completing physical and quality-of-life assessments (for example, blindness or dementia)
  • People who have surgery planned within the next 3 months
  • People who are being discharged from hospital to hospice care, assisted living, or an inpatient rehabilitation facility (discharge to an independent living senior facility is acceptable)
  • People whose treating doctor or the study team considers participation to be unsafe
  • People currently taking part in another clinical trial that has not yet finished its follow-up period
  • People who did not wear the study activity tracker (Actigraph) for enough time during the initial roll-in phase — specifically, fewer than 4 days out of 10 where it was worn for at least 10 hours (a limited allowance exists for slightly reduced wear — confirm with trial site)
  • People who are unable to complete their baseline study visit within 4 weeks of finishing the activity tracker monitoring period

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Brian R Lindman, MD, MSCI, Vanderbilt University Medical Center

Phone: 615-589-6076

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
5 August 2024
Est. completion
1 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Average daily total activity counts

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov