NCT01045343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 17, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

January 8, 2010

Last Update Submit

April 13, 2012

Conditions

Heart Failure

Keywords

heart failurehome monitoringintegrated diagnosticsCardiac Resynchronization Therapy with Defibrillator (CRT D)

Outcome Measures

Primary Outcomes (6)

  • Change in subject self-care utilizing the Self-Care of Heart Failure Index

    Baseline, 3 months, 6 months, 9 months

  • Proportion of time clinician and subject complied to protocol requirements for the new heart failure diagnostic system (patient tools and HF clinician website)

    Baseline to 9 months

  • Number of clinical actions and types of health care utilizations in which actions are initiated

    Baseline to 9 months

  • Subject outcomes including emergency room (ER) visits, hospitalization and death

    Baseline to 9 months

  • Functional class using measurements including 6-minute hall walk and New York Heart Association class

    Hall walk (Baseline to 9 months), NYHA (Baseline, 3 months, 6 months, 9 months)

  • Quality of life and depression scores utilizing measures including the Minnesota Living with Heart Failure Questionnaire and Patient Health Questionnaire

    Baseline, 3 months, 6 months, 9 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR
Other: Routine in office visits

Integrated Diagnostics Arm

EXPERIMENTAL
Other: Integrated diagnositic system

Interventions

Integrated diagnositic systemOTHER

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.

Integrated Diagnostics Arm
Routine in office visitsOTHER

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

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Anchorage, Alaska, United States

Location

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Jackson, Mississippi, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Voorhees Township, New Jersey, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Abington, Pennsylvania, United States

Location

Unknown Facility

Doylestown, Pennsylvania, United States

Location

Unknown Facility

Lancaster, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Office Visits

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • INDICATE HF Team

    Medtronic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 17, 2012

Record last verified: 2012-04

Locations

US(13)