Trials / Not Yet Recruiting
Not Yet RecruitingNCT07412626
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- Sponsor
- Robert Pickett · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-12-01
- Completion
- 2028-03-01
- First posted
- 2026-02-17
- Last updated
- 2026-02-17
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07412626. Inclusion in this directory is not an endorsement.