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

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

Study Overview

• Status: Completed
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
  • Florida
    • Tampa, Florida, United States, 33511-5908
      • Bay Area Cardiology
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102-2568
      • United Heart and Cardiovascular
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Morristown Memorial Hospital
  • New York
    • Utica, New York, United States, 13501-5930
      • Mohawk Valley Heart Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219-2364
      • University of Cincinnati
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients who are admitted to the hospital.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Discharge to 30 days post discharge

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Director: READMIT-HF Study Team, Medtronic

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 6, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: READMIT-HF