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OpenTrials
Completed

NCT Number: NCT01574144

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Alfred Hospital, Melbourne, Victoria, Australia

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVIVO™ PiiX Patch Monitor System

Device

External monitoring for 30 days post-discharge.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Observational Study of Reducing 30-day Admissions in Post-discharge Subjects

Acronym: READMIT-HF

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2012
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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