Registry for Acute Decompensated Heart Failure Patients Admitted to the ER

NCT00364325 | Completed

• 1 other identifier: CR005215
• Study Type: observational
• Target: 18,920
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to collect data on the medical management of patients presenting to the Emergency Department who are treated for Acute Decompensated Heart Failure (ADHF) in a hospital setting that has incorporated a disease management program for heart failure.

Conditions

Heart Failure, Congestive; Heart Decompensation

Keywords

Heart failure, congestive; Heart decompensation

Outcome Measures

Primary Outcomes (1)

• The registry will capture information about the medical care that the patient has received including hospital/ emergency department course, major procedures, medication received, emergency room disposition and in hospital death

  Data will be collected, beginning with care in the Emergency Department and ending with the patient's Discharge from the Emergency Department or hospital discharge, transfer to another hospital, or in-hospital death.

Secondary Outcomes (1)

• Baseline demographic information (age,sex, gender,race), initial evaluation, laboratory results and medical history.

  From admission to the emergency depatment until discharge

Study Arms (1)

001

Other: Acute Decompensated Heart Failure

Interventions

Acute Decompensated Heart Failure OTHER

Standard of Care

001

Eligibility Criteria

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

Study Population

The study population consists of all consecutive adults patients seen in the Emergency department of an acute care hospital and treated actively for Acute Decompensated Heart Failure (ADHF) where the condition is defined clinically as new onset of Heart Failure with decompensation or chronic heart failure with decompensation. Patient eligibility is based upon the presence of a hospital discharge and/or Emergency department diagnosis of ADHF and is not tied to the use of any specific therapeutic agent or regimen.

You may qualify if:

• Age greater than or equal to 18 years at the time of ED treatment
• Received or is eligible to receive a principal ED and/or hospital discharge diagnosis of ADHF
• ADHF is present as determined clinically by the patient care team and as documented in the DRG (Diagnosis-related Group) or APC (Ambulatory Payment Classifications) codes, and ADHF is the focus of treatment
• If required by site IRB/IEC patient (or legally acceptable representative) must be able to give informed consent for participation

You may not qualify if:

• ADHF is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this ED or hospital episode
• Patient was not treated in ED during this episode of care
• Participation in any clinical trial that precludes use of a Disease Management Program (specific component of the disease are managed in an integrated manner by a team of physicians, pharmacists, nurses and communication experts)

Sponsors & Collaborators

• Scios, Inc.: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: July 1, 2004
• Study Completion: March 1, 2006
• Last Updated: April 28, 2010

Record last verified: 2010-04