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Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure (INDICATE HF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01045343
First received: January 8, 2010
Last updated: April 13, 2012
Last verified: April 2012
History of Changes

January 8, 2010
April 13, 2012
March 2010
February 2012   (final data collection date for primary outcome measure)
  • Change in subject self-care utilizing the Self-Care of Heart Failure Index [ Time Frame: Baseline, 3 months, 6 months, 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of clinical actions and types of health care utilizations in which actions are initiated [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]
  • Subject outcomes including emergency room (ER) visits, hospitalization and death [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01045343 on ClinicalTrials.gov Archive Site
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Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure
Integrated Diagnostics Can Alter Heart Failure

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Heart Failure
  • Other: Integrated diagnositic system
    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.
  • Other: Routine in office visits
    Heart failure will be managed with scheduled in-office visits every three months.
  • Active Comparator: Control Arm
    Intervention: Other: Routine in office visits
  • Experimental: Integrated Diagnostics Arm
    Intervention: Other: Integrated diagnositic system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01045343
INDICATE HF
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Study Chair: INDICATE HF Team Medtronic
Medtronic Cardiac Rhythm Disease Management
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP