Assessing Outcomes in ED Patients With RV Failure

Not Applicable

Terminated

• Conditions: Right Heart Failure
• Interventions: Diagnostic Test: Clinical Pathway

• Registration Number: NCT03073629
• Lead Sponsor: Indiana University

Brief Summary

Millions of Americans seek emergency care for acute shortness of breath, and many undergo computerized tomographic pulmonary angiography (CTPA) testing that is negative for acute disease. Management of patients with persistent shortness of breath despite normal testing continues to pose a challenge for clinicians. Right ventricular (RV) failure is a common cause of dyspnea that brings patients to the emergency department (ED), however, it is often not considered in the differential diagnosis, remains unrecognized, or patients are not properly followed up once diagnosed. Delays in diagnosis and management of RV failure are associated with poor outcomes. The investigators propose a novel clinical pathway, which entails identifying and enrolling patients with RV failure in the ED, then referring them to a specialized cardiovascular clinic where they will receive a standardized evaluation and management plan. Our hypothesis is that management of RV failure, through this pathway, will improve patient outcomes when compared to standard care. The primary outcome will assess 1-year unscheduled healthcare visits.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-02-23
• Study Completion: 2017-02-23
• Status Verified: 2017-03
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-08
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• adult patients > 18 years old,
• with a non-significant CTPA scan (i.e. no acute disease), dyspnea PLUS an emergency physician performed echocardiogram with isolated RV failure OR CTPA scan with evidence of pulmonary hypertension OR comprehensive echocardiogram within 3 months of index hospital visit showing isolated RV dysfunction

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Exclusion Criteria

• Currently being evaluated and/or treated for RV failure or PH,
• those unable to have a comprehensive echocardiography performed,
• those with indeterminate RV function OR LV dysfunction on comprehensive echocardiography, and
• those patients with circumstances where they may be lost to follow-up (homeless, prisoner, severe psychiatric disorder, no reliable contact information).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical Pathway Cohort	Clinical Pathway	Patients with isolated RV failure will be evaluated and managed in a specialized cardiovascular clinic.

Primary Outcome Measures

Name	Time	Method
Unscheduled healthcare visits	1 year

Secondary Outcome Measures

Name	Time	Method
Change in quality of life via the SF-36	1 year
Mortality	1 year
Hospital re-admissions	1 year

Trial Locations

Locations (1)

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States