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Completed

NCT Number: NCT01045343

Feasibility Study of an Integrated Diagnostic System to Manage 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anchorage, Alaska, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated diagnositic system

Other

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.

Routine in office visits

Other

Heart failure will be managed with scheduled in-office visits every three months.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Integrated Diagnostics Can Alter Heart Failure

Acronym: INDICATE HF

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2010
Registry last updated
Apr 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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