Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the potential benefits of a new heart failure diagnostic system for heart failure patients with implanted cardiac resynchronization therapy devices. This system consists of patient tools, a new heart failure risk score and a new clinician website. This study will evaluate this new system as a whole and establish the feasibility of implementing it into clinical practice.

Official Title
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Integrated Diagnostics Can Alter Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Integrated diagnositic system
* Other: Routine in office visits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing and able to provide written informed consent Subject is at least 18 years of age Subject is willing and able to comply with the Clinical Investigation Plan Subject is currently enrolled in the Medtronic CareLink® Network Subject is currently a New Heart Association (NYHA) functional class III or NYHA functional class II with a heart failure related hospitalization within the past 180 days Subject has a Medtronic Concerto®/Consulta® cardiac resynchronization therapy (CRT)device implanted for at least 180 days Subject has been prescribed daily oral diuretic therapy for the management of heart failure Exclusion Criteria: Subject is enrolled in a concurrent study with the exception of a study approved by the INDICATE HF Clinical Trial Leader Subject has a life expectancy of less than 1 year Subject's CRT device has an estimated battery life of less than 2 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br> | Other: Routine in office visits<br>* Heart failure will be managed with scheduled in-office visits every three months.<br>|
| Experimental: Integrated Diagnostics Arm<br> | Other: Integrated diagnositic system<br>* Heart failure will be managed using the integrated diagnostic system which consists of patient tools and a new Heart Failure Clinician's website which displays a new Heart Failure Risk score. This Heart Failure Clinician's website will be reviewed every 2 weeks in addition to scheduled in-office visits every three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subject self-care utilizing the Self-Care of Heart Failure Index |  | Baseline, 3 months, 6 months, 9 months | 
| Proportion of time clinician and subject complied to protocol requirements for the new heart failure diagnostic system (patient tools and HF clinician website) |  | Baseline to 9 months | 
| Number of clinical actions and types of health care utilizations in which actions are initiated |  | Baseline to 9 months | 
| Subject outcomes including emergency room (ER) visits, hospitalization and death |  | Baseline to 9 months | 
| Functional class using measurements including 6-minute hall walk and New York Heart Association class |  | Hall walk (Baseline to 9 months), NYHA (Baseline, 3 months, 6 months, 9 months) | 
| Quality of life and depression scores utilizing measures including the Minnesota Living with Heart Failure Questionnaire and Patient Health Questionnaire |  | Baseline, 3 months, 6 months, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, home monitoring, integrated diagnostics, Cardiac Resynchronization Therapy with Defibrillator (CRT D)