Registry for Acute Decompensated Heart Failure Patients Admitted to ER - Full Text View

Sponsored by:	Scios, Inc.
Information provided by:	Scios, Inc.
ClinicalTrials.gov Identifier:	NCT00364325

Purpose

Observational, multicenter, baseline controlled registry of consecutive patients presenting to the ED for treatment of known or suspected ADHF.

Condition
Heart Decompensation Heart Failure, Congestive

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Observational
Official Title:	ADHERE Emergency Module-Registry of Acute Heart Failure Patients Treated in the Emergency Department Using Heart Failure Disease Management.

Further study details as provided by Scios, Inc.:

Estimated Enrollment:	60000
Study Start Date:	July 2004
Estimated Study Completion Date:	March 2006

Detailed Description:

To 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. To collect data 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; 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 or APC 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 the DM components

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364325

Sponsors and Collaborators

Scios, Inc.

Investigators

Study Director:

Scios, Inc. Clinical Trial

Scios, Inc.

More Information

Study ID Numbers:	CR005215
Study First Received:	August 11, 2006
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00364325
Health Authority:	United States: Institutional Review Board

Keywords provided by Scios, Inc.:

Heart decompensation
Heart failure, congestive

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Emergencies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009