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

Acute Decompensated Heart Failure Clinical Trial

— READMIT-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574144
• Other study ID #: READMIT-HF
• Status: Completed
• Start date: April 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2022
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Device:
• AVIVO™ PiiX Patch Monitor System
External monitoring for 30 days post-discharge.

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
United States	University of Cincinnati	Cincinnati	Ohio
United States	Scripps Green Hospital	La Jolla	California
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Vanderbilt University	Nashville	Tennessee
United States	United Heart and Cardiovascular	Saint Paul	Minnesota
United States	Bay Area Cardiology	Tampa	Florida
United States	Mohawk Valley Heart Institute	Utica	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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