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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01574144
First received: April 3, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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 Intervention
Acute Decompensated Heart Failure
Device: AVIVO™ PiiX Patch Monitor System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Reducing 30-day Admissions in Post-discharge Subjects

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Number of health care utilizations 30 days post-discharge [ Time Frame: 30 days post-discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in impedance 30 days post-discharge [ Time Frame: 30 days post-discharge ] [ Designated as safety issue: No ]
    Measures change in weight and tissue impedance throughout the monitoring period post-discharge


Enrollment: 70
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574144

Locations
United States, California
Scripps Green Hospital
LaJolla, California, United States, 92037
United States, Florida
Bay Area Cardiology
Tampa, Florida, United States, 33511-5908
United States, Minnesota
United Heart and Cardiovascular
St. 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 Disease Management
Investigators
Study Director: READMIT-HF Study Team Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01574144     History of Changes
Other Study ID Numbers: READMIT-HF
Study First Received: April 3, 2012
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board
Australia: National Health and Medical Research Council

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 30, 2014