Acute Decompensated Heart FailureREADMIT-HFNCT01574144
REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
An observational study of Acute Decompensated Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in 2 countries.
Trial summary
The purpose of this observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (HF) Changes in physiologic data are expected to correlate with 30-day readmission rates in this population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- AVIVO™ PiiX Patch Monitor System
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2012to Aug 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Heart failure patients who are admitted to the hospital.
Who may be able to join
- Subject with acute decompensated heart failure
- Subject (or legal guardian) willing to give consent for their participation
- Subject ≥18 years of age
Who cannot join
- Subject who is expected to receive a heart transplant or a ventricular assist device within 6 months
- Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG Lead II orientation)
- Subject with known allergies or hypersensitivities to adhesives or hydrogels
- Subject with implantable devices with active minute ventilation sensors.
- Subject who will not comply to study protocol requirements. This includes completing required data collection, and attending required follow up study visits.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
University of Cincinnati
Cincinnati, Ohio, 45219-2364
Scripps Green Hospital
La Jolla, California, 92037
Morristown Memorial Hospital
Morristown, New Jersey, 07962
Vanderbilt University
Nashville, Tennessee, 37232
United Heart and Cardiovascular
Saint Paul, Minnesota, 55102-2568
Bay Area Cardiology
Tampa, Florida, 33511-5908
Mohawk Valley Heart Institute
Utica, New York, 13501-5930
About this study
Official title: Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
The purpose of this observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (HF)
Changes in physiologic data are expected to correlate with 30-day readmission rates in this population
Read the detailed description
This is a multi-center, non-randomized feasibility study aimed at obtaining data from systolic and diastolic HF subjects in the hospital, with continued monitoring using an external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected during the hospital stay and at in office follow-up visits at 1 week and 1 month post-hospital discharge
The data will help generate hypotheses and aid in determining whether development of a detection algorithm for acute heart failure decompensation is feasible. Due to the feasibility nature of this study there is no minimum required sample size but it is anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the United States and one (1) study site in Australia
The study objectives are:
- Collect and characterize physiologic data from subjects with acute decompensated heart failure.
- Characterization of data related to health care utilizations within 30-days Post-discharge
- Correlation between patch monitor collected data and inpatient clinical data
- Correlation between patch monitor data and other clinical data collected after patient discharge (30-60 days)
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- AVIVO™ PiiX Patch Monitor System
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVIVO™ PiiX Patch Monitor SystemDevice
External monitoring for 30 days post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| AVIVO™ PiiX Patch Monitor System | Heart failure patients monitored continuously for 30 days post-discharge. Receives: Device: AVIVO™ PiiX Patch Monitor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Health Care Utilizations
Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
Measured: 30 days post-discharge
Secondary outcomes (1)
Change in Body Weight Per Unit Change in Thoracic Impedance
Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.
Measured: Discharge to 30 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- READMIT-HF Study Team, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574144
- Sponsor's protocol ID
- READMIT-HF
- Acronym
- READMIT-HF
- Status last verified
- Dec 2022
- First submitted
- 3 Apr 2012
- Last updated
- 30 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
- ClinicalTrials.gov ID
- NCT01574144
- Acronym / sponsor ID
- READMIT-HF / READMIT-HF
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Posted 29 Oct 2018
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 observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (HF)
Changes in physiologic data are expected to correlate with 30-day readmission rates in this population
Detailed description
This is a multi-center, non-randomized feasibility study aimed at obtaining data from systolic and diastolic HF subjects in the hospital, with continued monitoring using an external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected during the hospital stay and at in office follow-up visits at 1 week and 1 month post-hospital discharge
The data will help generate hypotheses and aid in determining whether development of a detection algorithm for acute heart failure decompensation is feasible. Due to the feasibility nature of this study there is no minimum required sample size but it is anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the United States and one (1) study site in Australia
The study objectives are:
- Collect and characterize physiologic data from subjects with acute decompensated heart failure.
- Characterization of data related to health care utilizations within 30-days Post-discharge
- Correlation between patch monitor collected data and inpatient clinical data
- Correlation between patch monitor data and other clinical data collected after patient discharge (30-60 days)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVIVO™ PiiX Patch Monitor System | – | Device: AVIVO™ PiiX Patch Monitor SystemHeart failure patients monitored continuously for 30 days post-discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients who are admitted to the hospital.
Key inclusion criteria (3 listed)
- Subject with acute decompensated heart failure
- Subject (or legal guardian) willing to give consent for their participation
- Subject ≥18 years of age
Key exclusion criteria (5 listed)
- Subject who is expected to receive a heart transplant or a ventricular assist device within 6 months
- Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG Lead II orientation)
- Subject with known allergies or hypersensitivities to adhesives or hydrogels
- Subject with implantable devices with active minute ventilation sensors.
- Subject who will not comply to study protocol requirements. This includes completing required data collection, and attending required follow up study visits.
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 |
|---|---|---|
| AVIVO™ PiiX Patch Monitor SystemExternal monitoring for 30 days post-discharge. | Device | AVIVO™ PiiX Patch Monitor System |
Primary outcome
Percentage of Participants With Health Care Utilizations
Time frame: 30 days post-discharge
Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
1 secondary outcome
Change in Body Weight Per Unit Change in Thoracic Impedance
Time frame: Discharge to 30 days post discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
READMIT-HF Study Team study director
Medtronic
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Health Care Utilizations (time frame: 30 days post-discharge). 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 30 Dec 2022.