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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03073629
Other study ID # 1605974831
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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