Clinical trial NCT02996032: CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Failure Study
Official title: CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Heart Failure Society of America
name: Emergency Medicine Foundation
First posted: 2016-12-19
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized with a diagnosis of acute decompensated heart failure.

Brief summary: This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines) can predict patients at higher risk of readmission within 30 days of hospital discharge for decompensated heart failure.

Detailed description: Heart failure (HF) resulting in congestion is the leading cause for admission in persons ≥65 years of age and 20-25% of such patients are readmitted within 30 days of discharge. Efforts to treat HF are difficult without a simple method to detect early signs of congestion to direct therapy. Ultrasound can detect evidence of congestion by increased cardiac filling pressures two weeks prior to other markers of congestion such as weight gain or patient symptoms. Corrected flow time (FTc) measured by ultrasound, is an easy to perform vascular measure and correlates with cardiac filling pressures. Despite the relationship between FTc and filling pressures, this measure has never been studied in HF. The primary aim is to determine if FTc can predict patients at risk of readmission within 30 days. As a secondary aim, the investigators plan to validate a small study of patients reporting the ability of pulmonary ultrasound to predict readmissions. This study demonstrated pulmonary ultrasound was 100% sensitive and 68% specific for predicting readmission at 3 months, however this investigation was small and validation is needed. It is expected ultrasound will be able to accurately and safely predict patients who will be readmitted within 30 days of discharge. This proposal is aimed at identifying a noninvasive measure to better assess congestion from HF and predict readmissions.

Eligibility criteria: Inclusion Criteria:

* English Speaking
* Being admitted for heart failure with expected hospital stay of 72 hours

Exclusion Criteria:

* Unable to provide consent

Primary outcomes:
measure: Change in Corrected Flow Time
timeFrame: Measured daily during hospitalization and then correlated to 30 day readmissions.Mean hospitalization for the study population is 9 days, but will be measured during the duration of their hospitalization.
Secondary outcomes:
measure: Change in Pulmonary Ultrasound (B-Lines)
timeFrame: Measured daily during hospitalization and correlated to 30 day readmissions. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of hospitalization.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Assistant Professor
name: Joseph Pare, MD MHS RDMS
role: PRINCIPAL_INVESTIGATOR
References: