Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure

Medtronic Cardiac Rhythm and Heart Failure136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

136

Conditions

Heart Failure

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.

Routine in office visitsOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Unnamed facility

Anchorage, Alaska, United States

Unnamed facility

Aurora, Colorado, United States

Unnamed facility

Tampa, Florida, United States

Unnamed facility

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: Baseline to 9 months

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

Time frame: Baseline to 9 months

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

Time frame: Baseline to 9 months

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)

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

Data from ClinicalTrials.gov

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