Registry for Acute Decompensated Heart Failure Patients Admitted to the ER

NCT ID: NCT00364325

Last Updated: 2010-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18920 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2006-03-31

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.

Detailed Description

This is an Observational (individuals are observed or certain outcomes are measured. no attempt is made to affect the outcome), multi-center registry study of patients presenting to the Emergency Department (ED) for treatment of known or suspected Acute Decompensated Heart Failure (ADHF). Data will be collected on the medical management of patients presenting to the ED who are treated for ADHF in a hospital setting incorporating a disease management program for heart failure. The study will evaluate change in clinical management and outcomes of ADHF patients treated in the ED after ED implementation of three or more components of a disease management program for heart failure. The results are intended to assist hospitals in evaluating and improving quality of care for patients with ADHF by tracking quality indicators and providing site-specific benchmark reports and national benchmark reports. This registry considers patients treated with any therapy for ADHF

Conditions

Heart Failure, Congestive; Heart Decompensation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

001

Acute Decompensated Heart Failure

Intervention Type: OTHER

Standard of Care

Interventions

Acute Decompensated Heart Failure

Standard of Care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scios, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Scios

Principal Investigators

Scios, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Scios, Inc.

Other Identifiers

CR005215

Identifier Type: -

Identifier Source: org_study_id