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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Robert Pickett
Study ID
NCT07412626
Status
Not Yet Recruiting

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Conditions

  • Congestive Heart Failure Chronic
  • Low Ejection Fraction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Heartlogic Diagnostic Tool Threshold Change — DEVICE
    Heart Logic threshold set to 10 (from 16)
  • Heartlogic Diagnostic Tool Unchanged Threshold — DEVICE
    Heartlogic Threshold to remain at 16, which is the normal limit.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Active Treatment Arm
    Heart Logic threshold set to 10 (from 16) will trigger a treatment algorithm, which includes up titration of GDMT
  • Placebo Comparator: Control Arm
    Heart Logic transmission of 16 or greater may be reported to the appropriate device clinic staff by Latitude transmission and then referred to the appropriate treating provider. Medication changes will be based upon physician preference/standards. Repeat transmissions, follow-up, laboratory studies will be per physician preference.

Primary Outcome Measure

Hospitalizations [ Time Frame: 365 Days ]

Central Contacts

  • Robert Pickett, MD
    615-329-5144
    [email protected]
  • Saint Thomas Heart at Saint Thomas Midtown
    615-329-5144

Locations (2)

FacilityCityStateZIPSite coordinators
Ascension St. Vincent Medical GroupIndianapolisIndiana46260
Jasen Gilge, MD
[email protected]
317-338-6666
Ascension St. Vincent Medical Group
317-338-6666
Jasen Gilge, MD (PRINCIPAL_INVESTIGATOR)
Saint Thomas Heart at Saint Thomas MidtownNashvilleTennessee37203
Robert Pickett, MD
[email protected]
615-329-5144
Saint Thomas Heart at Saint Thomas Midtown
615-329-5144
Robert Pickett, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By research site
Ascension St. Vincent Medical Group· Indianapolis, INSaint Thomas Heart at Saint Thomas Midtown· Nashville, TN

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