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

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ClinicalTrials.gov Identifier: NCT01045343
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment
Heart Failure Other: Integrated diagnositic system Other: Routine in office visits

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Integrated Diagnostics Can Alter Heart Failure
Study Start Date : March 2010
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in subject self-care utilizing the Self-Care of Heart Failure Index [ Time Frame: Baseline, 3 months, 6 months, 9 months ]
  2. 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 ]
  3. Number of clinical actions and types of health care utilizations in which actions are initiated [ Time Frame: Baseline to 9 months ]
  4. Subject outcomes including emergency room (ER) visits, hospitalization and death [ Time Frame: Baseline to 9 months ]
  5. 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) ]
  6. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045343

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 and Heart Failure
Study Chair: INDICATE HF Team Medtronic

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01045343     History of Changes
Other Study ID Numbers: INDICATE HF
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases