Integrated Diagnostics Can Alter Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 136
- Primary Endpoint
- Change in subject self-care utilizing the Self-Care of Heart Failure Index
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in subject self-care utilizing the Self-Care of Heart Failure Index
Time Frame: 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)
Time Frame: Baseline to 9 months
Number of clinical actions and types of health care utilizations in which actions are initiated
Time Frame: Baseline to 9 months
Subject outcomes including emergency room (ER) visits, hospitalization and death
Time Frame: Baseline to 9 months
Functional class using measurements including 6-minute hall walk and New York Heart Association class
Time Frame: 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
Time Frame: Baseline, 3 months, 6 months, 9 months