CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Failure Study

NCT ID: NCT02996032

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 187 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-04-30

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart Failure

Patients admitted to the hospital with acute decompensated heart failure expected to be hospitalized for at least 72 hours

Vascular and Pulmonary Ultrasound

Intervention Type: OTHER

Interventions

Vascular and Pulmonary Ultrasound

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Unable to provide consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Failure Society of America

UNKNOWN

Sponsor Role: collaborator

Emergency Medicine Foundation

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joseph Pare

Assistant Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Pare, MD MHS RDMS

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Boston University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-35112

Identifier Type: -

Identifier Source: org_study_id