Evaluation of the HeartLogic Diagnostic in Optimizing Guideline-directed Medical Therapy in Patients With Congestive Heart Failure and Chronically Low Ejection Fractions (EFs)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heartlogic Diagnostic Tool Threshold Change, Heartlogic Diagnostic Tool Unchanged Threshold.
- Who it may be relevant to
- Registry conditions: Congestive Heart Failure Chronic, Low Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HeartLogic Optimization of CHF Medications in Chronic Low EF Population: A Follow-on Study
Overview
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.
Detailed description
Investigator-sponsored post-market, randomized, multicenter trial evaluating the HeartLogic diagnostic in optimizing GDMT in patients with chronically low EF
Interventions
- Device Heartlogic Diagnostic Tool Threshold Change
Heart Logic threshold set to 10 (from 16) - Device Heartlogic Diagnostic Tool Unchanged Threshold
Heartlogic Threshold to remain at 16, which is the normal limit.
Primary outcome measures
- Hospitalizations [Time frame: 365 Days]
Secondary outcome measures (2)
- Number of ICD Shocks [Time frame: 365 Days]
- nt-ProBNP [Time frame: 365 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Ascension St. Vincent Medical Group — Indianapolis
- Saint Thomas Heart at Saint Thomas Midtown — Nashville
Identifiers
NCT: NCT07412626 · RTN20250021