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Assessing Outcomes in ED Patients With RV Failure

Primary Purpose

Right Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Pathway
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Clinical Pathway Cohort

Standard Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Unscheduled healthcare visits

Secondary Outcome Measures

Mortality
Hospital re-admissions
Change in quality of life via the SF-36

Full Information

First Posted
March 2, 2017
Last Updated
June 13, 2022
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03073629
Brief Title
Assessing Outcomes in ED Patients With RV Failure
Official Title
Implementation of a Clinical Pathway to Improve Outcomes in Emergency Department Patients With Right Ventricular Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Found not to be feasible
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Pathway Cohort
Arm Type
Active Comparator
Arm Description
Patients with isolated RV failure will be evaluated and managed in a specialized cardiovascular clinic.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Patients with isolated RV failure will receive standard care and follow up.
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinical Pathway
Intervention Description
Patients will be evaluated and managed in a specialized cardiovascular clinic to determine the etiology of right heart failure and begin treatment.
Primary Outcome Measure Information:
Title
Unscheduled healthcare visits
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
1 year
Title
Hospital re-admissions
Time Frame
1 year
Title
Change in quality of life via the SF-36
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessing Outcomes in ED Patients With RV Failure

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