REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/31/2018
Start Date:April 2012
End Date:August 2013

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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

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)

Inclusion Criteria:

- Subject with acute decompensated heart failure

- Subject (or legal guardian) willing to give consent for their participation

- Subject ≥18 years of age

Exclusion Criteria:

- 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.
We found this trial at
8
sites
La Jolla, California 92037
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Melbourne, Victoria 3004
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Melbourne,
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Morristown, NJ
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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Saint Paul, Minnesota 55102
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Saint Paul, MN
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Tampa, Florida 33511
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Tampa, FL
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Utica, NY
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