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Assessing Outcomes in ED Patients With RV Failure

Implementation of a Clinical Pathway to Improve Outcomes in Emergency Department Patients With Right Ventricular Failure

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03073629
Enrollment
2
Registered
2017-03-08
Start date
2017-01-01
Completion date
2017-02-23
Last updated
2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Right Heart Failure

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.

Interventions

DIAGNOSTIC_TESTClinical Pathway

Patients will be evaluated and managed in a specialized cardiovascular clinic to determine the etiology of right heart failure and begin treatment.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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).

Design outcomes

Primary

MeasureTime frame
Unscheduled healthcare visits1 year

Secondary

MeasureTime frame
Mortality1 year
Hospital re-admissions1 year
Change in quality of life via the SF-361 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026