Assessing Outcomes in ED Patients With RV Failure

Indiana University

Status: Terminated

Conditions: Right Heart Failure

Treatments: Diagnostic Test: Clinical Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT03073629

1605974831

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Clinical Pathway Cohort

Active Comparator group

Description:

Patients with isolated RV failure will be evaluated and managed in a specialized cardiovascular clinic.

Treatment:

Diagnostic Test: Clinical Pathway

Standard Care

No Intervention group

Description:

Patients with isolated RV failure will receive standard care and follow up.