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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
  Purpose

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.


Condition Intervention
Heart Failure
 Other: Integrated diagnositic system
Other: Routine in office visits

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Integrated Diagnostics Can Alter Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 ]

Enrollment: 136
Study Start Date: March 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Arm Other: Routine in office visits
Heart failure will be managed with scheduled in-office visits every three months.
Experimental: Integrated Diagnostics Arm 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045343

Locations
United States, Alaska
Anchorage, Alaska, United States
United States, Colorado
Aurora, Colorado, United States
United States, Florida
Tampa, Florida, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Jersey
Voorhees, New Jersey, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Abington, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Vermont
Burlington, Vermont, United States
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: INDICATE HF Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01045343     History of Changes
Other Study ID Numbers: INDICATE HF
Study First Received: January 8, 2010
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
heart failure
home monitoring
integrated diagnostics
Cardiac Resynchronization Therapy with Defibrillator (CRT D)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013