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

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ClinicalTrials.gov Identifier: NCT01574144
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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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


Condition or disease Intervention/treatment
Acute Decompensated Heart Failure Device: AVIVO™ PiiX Patch Monitor System

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
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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
AVIVO™ PiiX Patch Monitor System
Heart failure patients monitored continuously for 30 days post-discharge.
 Device: AVIVO™ PiiX Patch Monitor System
External monitoring for 30 days post-discharge.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Body Weight Per Unit Change in Thoracic Impedance [ Time Frame: Discharge to 30 days post discharge ]
    Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients who are admitted to the hospital.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574144


Locations
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United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
United States, Florida
Bay Area Cardiology
Tampa, Florida, United States, 33511-5908
United States, Minnesota
United Heart and Cardiovascular
Saint Paul, Minnesota, United States, 55102-2568
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New York
Mohawk Valley Heart Institute
Utica, New York, United States, 13501-5930
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219-2364
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Director: READMIT-HF Study Team Medtronic
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01574144    
Other Study ID Numbers: READMIT-HF
First Posted: April 10, 2012    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: February 2018
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases