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Evaluation of the HeartLogic Diagnostic in Optimizing Guideline-directed Medical Therapy in Patients With Congestive Heart Failure and Chronically Low Ejection Fractions (EFs)

HeartLogic Optimization of CHF Medications in Chronic Low EF Population: A Follow-on Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding HeartLogic alerts to usual heart failure care can reduce hospital stays and improve daily life. It is for adults with heart failure whose hearts pump much less blood than normal and who have or are getting a heart device that works with HeartLogic.

The goal of this trial is to determine if the addition of the Heart Logic diagnostic alerts to standard of care therapies will lessen hospitalizations and improve quality of life in patients with heart failure.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Ejection fraction (EF) of 35% or less. EF measures how much blood the heart pumps out with each beat.
  • A hospital stay in the past 2 years, or worsening heart failure in the past 12 months that was treated without a hospital stay. For care without a hospital stay, symptoms must have reached NYHA class III or IV: major limits on activity or symptoms at rest.
  • Have or be getting an ICD or CRT-D that works with HeartLogic. These devices treat dangerous heart rhythms; a CRT-D also helps the heart beat in sync.
  • May join when the device is first placed, when its battery unit is replaced, or at the 2-week wound check.
  • If the device was placed earlier, must have had a hospital stay showing worsening heart failure within 6 months. The device must have at least 1 year of battery life left.

Who can't join

  • Do not agree to take part.
  • Expected to live less than 1 year.
  • Have a recorded history of not following treatment instructions that limits medicine use.
  • Are on dialysis, a treatment that filters the blood when the kidneys cannot. Kidney problems without dialysis do not rule you out.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 years or older * EF \</=35% * Prior hospitalization within the last two years or prior decompensation to NYHA class III or IV over the last 12 months that was treated without hospitalization * HeartLogic capable ICD or CRT-D (Patients with HeartLogic capable ICD or CRT-D can be enrolled at time of de novo implantation or generator change out or at the time of the 2 week wound check. Prior Heart logic capable ICF or CRT-D implants can be enrolled if heart failure hospitalization shows decompensation within six months (prior implants must have at least 1 year battery life) Exclusion Criteria: * Refuse to give consent * Have Life expectancy of less than one-year * Documented noncompliance that limits medication use * Patients on Dialysis (renal insufficiency but not on dialysis is NOT an exclusion) * Pregnancy

Study sites (2)

IN

TN