Recruitment

Recruitment Status
Completed
Estimated Enrollment
100

Summary

Conditions
Acute Decompensated Heart Failure
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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)

Tracking Information

NCT #
NCT01574144
Collaborators
Not Provided
Investigators
Study Director: READMIT-HF Study Team Medtronic