Registry for Acute Decompensated Heart Failure Patients Admitted to the ER

Heart Failure, Congestive Clinical Trial

Official title:

Acute Decompensate Heart Failure National Registry ( ADHERE) Emergency Module (EM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364325
• Other study ID #: CR005215
• Status: Completed
• Phase: N/A
• First received: August 11, 2006
• Last updated: April 26, 2010
• Start date: July 2004
• Est. completion date: March 2006

Study information

• Verified date: April 2010
• Source: Scios, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18920
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure
• Heart Failure, Congestive

Intervention

Other:
• Acute Decompensated Heart Failure
Standard of Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scios, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Baseline demographic information (age,sex, gender,race), initial evaluation, laboratory results and medical history.		From admission to the emergency depatment until discharge	No