NCT02996032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

November 30, 2016

Last Update Submit

October 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Corrected Flow Time

    Daily corrected flow time measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of their hospitalization. Changes in corrected flow time values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Corrected Flow Time is a single measure performed serial with the same units of measure.

    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 (1)

  • Change in Pulmonary Ultrasound (B-Lines)

    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.

Study Arms (1)

Heart Failure

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

Other: Vascular and Pulmonary Ultrasound

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized with a diagnosis of acute decompensated heart failure.

You may qualify if:

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

You may not qualify if:

  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02119, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Joseph Pare, MD MHS RDMS

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 19, 2016

Study Start

November 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations