Heart FailureCONFIRM-HFNCT02026635
Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)
An observational study of Heart Failure, run by Thomas Jefferson University at 1 site in United States.
Trial summary
A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2015
- Phase
- Observational
- 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
Study population: hospital inpatients
Who may be able to join
- At least 18 years of age
- Admission for worsening of HF
- Discharged to home
- Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
- Enrolled in Carelink® system and able to transmit data
- Able to participate for at least 3 months
Who cannot join
- Post heart transplant or actively listed
- End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
- Stage IV or V chronic renal dysfunction (GFR <25 mol/min per 1.73 M2)
- Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
- Severe pulmonary hypertension not due to left-sided HF
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in Heart Failure Patients (CONFIRM-HF)
A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices
- Conditions
- Heart Failure
- Keywords
- heart failure, Optivol® cardiac device, Medtronic CareLink
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Optivol® Device in CareLink | A single cohort group of heart failure patients with already implanted Optivol® capable devices who are discharged home from the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions
Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge.
Measured: 90 days from enrollment
Secondary outcomes (2)
Heart Failure Clinical Events
Track HF re-admissions and other clinical encounters between 30 and 90 days post discharge for HF.
Measured: 90 days from enrollment
Assess Patient-Reported Quality of Life
Assess the association between the use of Cardiac Compass Report and OptiVol® and improved HF patient quality of life at both time points (30 and 90 days post discharge) utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: 90 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: No subjects enrolled
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 Thomas Jefferson UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- David J Whellan, MD MHS, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026635
- Sponsor's protocol ID
- 13P.296
- Acronym
- CONFIRM-HF
- Status last verified
- Feb 2015
- First submitted
- 16 Dec 2013
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in Heart Failure Patients (CONFIRM-HF)
- ClinicalTrials.gov ID
- NCT02026635
- Acronym / sponsor ID
- CONFIRM-HF / 13P.296
- Conditions
- Heart Failure
- Keywords
- heart failure, Optivol® cardiac device, Medtronic CareLink
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Jan 2014 (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.
A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optivol® Device in CareLink | – | –A single cohort group of heart failure patients with already implanted Optivol® capable devices who are discharged home from the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital inpatients
Key inclusion criteria (6 listed)
- At least 18 years of age
- Admission for worsening of HF
- Discharged to home
- Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
- Enrolled in Carelink® system and able to transmit data
Key exclusion criteria (5 listed)
- Post heart transplant or actively listed
- End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
- Stage IV or V chronic renal dysfunction (GFR <25 mol/min per 1.73 M2)
- Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
- Severe pulmonary hypertension not due to left-sided HF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions
Time frame: 90 days from enrollment
Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge.
2 secondary outcomes
Heart Failure Clinical Events
Time frame: 90 days from enrollment
Assess Patient-Reported Quality of Life
Time frame: 90 days from enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
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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.
David J Whellan, MD MHS principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Thomas Jefferson University at 1 site 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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions (time frame: 90 days from enrollment). 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 6 Feb 2015.