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Registry for Acute Decompensated Heart Failure Patients Admitted to the ER

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00364325
Enrollment
18920
Registered
2006-08-15
Start date
2004-07-31
Completion date
2006-03-31
Last updated
2010-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Decompensation, Heart Failure, Congestive

Keywords

Heart failure, congestive, Heart decompensation

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

Interventions

OTHERAcute Decompensated Heart Failure

Standard of Care

Sponsors

Scios, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
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 deathData 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

MeasureTime frame
Baseline demographic information (age,sex, gender,race), initial evaluation, laboratory results and medical history.From admission to the emergency depatment until discharge

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026