Back to resultsFeasibility Study of an Integrated Diagnostic System to Manage Heart Failure (INDICATE HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated diagnositic system
Routine in office visits
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring heart failure, home monitoring, integrated diagnostics, Cardiac Resynchronization Therapy with Defibrillator (CRT D)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Arm
Integrated Diagnostics Arm
Arm Description
Outcomes
Primary Outcome Measures
Change in subject self-care utilizing the Self-Care of Heart Failure Index
Proportion of time clinician and subject complied to protocol requirements for the new heart failure diagnostic system (patient tools and HF clinician website)
Number of clinical actions and types of health care utilizations in which actions are initiated
Subject outcomes including emergency room (ER) visits, hospitalization and death
Functional class using measurements including 6-minute hall walk and New York Heart Association class
Quality of life and depression scores utilizing measures including the Minnesota Living with Heart Failure Questionnaire and Patient Health Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT01045343
First Posted
January 8, 2010
Last Updated
April 13, 2012
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT01045343
Brief Title
Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure
Acronym
INDICATE HF
Official Title
Integrated Diagnostics Can Alter Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, home monitoring, integrated diagnostics, Cardiac Resynchronization Therapy with Defibrillator (CRT D)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Title
Integrated Diagnostics Arm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Integrated diagnositic system
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine in office visits
Intervention Description
Heart failure will be managed with scheduled in-office visits every three months.
Primary Outcome Measure Information:
Title
Change in subject self-care utilizing the Self-Care of Heart Failure Index
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
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
Title
Number of clinical actions and types of health care utilizations in which actions are initiated
Time Frame
Baseline to 9 months
Title
Subject outcomes including emergency room (ER) visits, hospitalization and death
Time Frame
Baseline to 9 months
Title
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)
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
INDICATE HF Team
Organizational Affiliation
Medtronic
Official's Role
Study Chair
Facility Information:
City
Anchorage
State/Province
Alaska
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Voorhees
State/Province
New Jersey
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Abington
State/Province
Pennsylvania
Country
United States
City
Doylestown
State/Province
Pennsylvania
Country
United States
City
Lancaster
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure
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