Assessing Outcomes in ED Patients With RV Failure

Right Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03073629
• Other study ID #: 1605974831
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: February 23, 2017

Study information

• Verified date: March 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure
• Right Heart Failure

Intervention

Diagnostic Test:
• Clinical Pathway
Patients will be evaluated and managed in a specialized cardiovascular clinic to determine the etiology of right heart failure and begin treatment.

Locations

Country	Name	City	State
United States	Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unscheduled healthcare visits		1 year
Secondary	Mortality		1 year
Secondary	Hospital re-admissions		1 year
Secondary	Change in quality of life via the SF-36		1 year