Clinical trial NCT01574144: REducing 30-day ADMIssions in posT-discharge Subjects (READMIT)
Official title: Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Decompensated Heart Failure
Keywords: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients who are admitted to the hospital.

Brief 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

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Health Care Utilizations
timeFrame: 30 days post-discharge
Secondary outcomes:
measure: Change in Body Weight Per Unit Change in Thoracic Impedance
timeFrame: Discharge to 30 days post discharge
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Tampa
country: United States
facility: Bay Area Cardiology
state: Florida
city: Saint Paul
country: United States
facility: United Heart and Cardiovascular
state: Minnesota
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Utica
country: United States
facility: Mohawk Valley Heart Institute
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: Medtronic
name: READMIT-HF Study Team
role: STUDY_DIRECTOR
References: