Assessing Outcomes in ED Patients With RV Failure

NCT ID: NCT03073629

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-02-23

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.

Conditions

Right Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical Pathway Cohort

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

Group Type: ACTIVE_COMPARATOR

Clinical Pathway

Intervention Type: DIAGNOSTIC_TEST

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

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical Pathway

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

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

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Frances Russell

Assistant Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1605974831

Identifier Type: -

Identifier Source: org_study_id