Heart FailureINDICATE HFNCT01045343
Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure
A study testing Integrated diagnositic system and Routine in office visits in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Integrated diagnositic system and Routine in office visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Abington, Pennsylvania
Study site
Anchorage, Alaska
Study site
Aurora, Colorado
Study site
Burlington, Vermont
Study site
Cincinnati, Ohio
Study site
Doylestown, Pennsylvania
Study site
Jackson, Mississippi
Study site
Lancaster, Pennsylvania
Study site
Louisville, Kentucky
Study site
Omaha, Nebraska
Study site
Philadelphia, Pennsylvania
Study site
Tampa, Florida
Study site
Voorhees Township, New Jersey
About this study
Official title: Integrated Diagnostics Can Alter 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.
- Conditions
- Heart Failure
- Being tested
- Integrated diagnositic system, Routine in office visits
- Keywords
- heart failure, home monitoring, integrated diagnostics, Cardiac Resynchronization Therapy with Defibrillator (CRT D)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Not described Receives: Other: Routine in office visits |
| Integrated Diagnostics Arm | Experimental | Not described Receives: Other: Integrated diagnositic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subject self-care utilizing the Self-Care of Heart Failure Index
Measured: 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)
Measured: Baseline to 9 months
Number of clinical actions and types of health care utilizations in which actions are initiated
Measured: Baseline to 9 months
Subject outcomes including emergency room (ER) visits, hospitalization and death
Measured: Baseline to 9 months
Functional class using measurements including 6-minute hall walk and New York Heart Association class
Measured: 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
Measured: Baseline, 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- INDICATE HF Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045343
- Sponsor's protocol ID
- INDICATE HF
- Acronym
- INDICATE HF
- Status last verified
- Apr 2012
- First submitted
- 8 Jan 2010
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Diagnostics Can Alter Heart Failure
- ClinicalTrials.gov ID
- NCT01045343
- Acronym / sponsor ID
- INDICATE HF / INDICATE HF
- Conditions
- Heart Failure
- Keywords
- heart failure, home monitoring, integrated diagnostics, Cardiac Resynchronization Therapy with Defibrillator (CRT D)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Routine in office visits |
| Integrated Diagnostics Arm | Experimental | Other: Integrated diagnositic system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated diagnositic systemHeart 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. | Other | Integrated Diagnostics Arm |
| Routine in office visitsHeart failure will be managed with scheduled in-office visits every three months. | Other | Control Arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
INDICATE HF Team study chair
Medtronic
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated diagnositic system and Routine in office visits in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subject self-care utilizing the Self-Care of Heart Failure Index (time frame: Baseline, 3 months, 6 months, 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2012.