Assessing Outcomes in ED Patients With RV Failure

NCT03073629 | Terminated

• 1 other identifier: 1605974831
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Unscheduled healthcare visits

  1 year

Secondary Outcomes (3)

• Mortality

  1 year

• Hospital re-admissions

  1 year

• Change in quality of life via the SF-36

  1 year

Study Arms (2)

Clinical Pathway Cohort

ACTIVE COMPARATOR

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

Diagnostic Test: Clinical Pathway

Standard Care

NO INTERVENTION

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

Interventions

Clinical Pathway DIAGNOSTIC_TEST

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

Clinical Pathway Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Methodist Hospital

Indianapolis, Indiana, 46203, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 8, 2017
• Study Start: January 1, 2017
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: June 15, 2022

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)