Clinical trial NCT01045343: Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure
Official title: Integrated Diagnostics Can Alter Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
home monitoring
integrated diagnostics
Cardiac Resynchronization Therapy with Defibrillator (CRT D)
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Change in subject self-care utilizing the Self-Care of Heart Failure Index
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Proportion of time clinician and subject complied to protocol requirements for the new heart failure diagnostic system (patient tools and HF clinician website)
timeFrame: Baseline to 9 months
measure: Number of clinical actions and types of health care utilizations in which actions are initiated
timeFrame: Baseline to 9 months
measure: Subject outcomes including emergency room (ER) visits, hospitalization and death
timeFrame: Baseline to 9 months
measure: Functional class using measurements including 6-minute hall walk and New York Heart Association class
timeFrame: Hall walk (Baseline to 9 months), NYHA (Baseline, 3 months, 6 months, 9 months)
measure: Quality of life and depression scores utilizing measures including the Minnesota Living with Heart Failure Questionnaire and Patient Health Questionnaire
timeFrame: Baseline, 3 months, 6 months, 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Aurora
country: United States
state: Colorado
city: Tampa
country: United States
state: Florida
city: Louisville
country: United States
state: Kentucky
city: Jackson
country: United States
state: Mississippi
city: Omaha
country: United States
state: Nebraska
city: Voorhees
country: United States
state: New Jersey
city: Cincinnati
country: United States
state: Ohio
city: Abington
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Burlington
country: United States
state: Vermont
Study officials:
affiliation: Medtronic
name: INDICATE HF Team
role: STUDY_CHAIR
References: