Registry for Acute Decompensated Heart Failure Patients

Completed

• Conditions: Heart Failure, Congestive; Heart Decompensation
• Interventions: Other: Acute Decompensated Heart Failure

• Registration Number: NCT00366639
• Lead Sponsor: Scios, Inc.

Brief Summary

The purpose of the ADHERE study is to develop a multi-center, observational, open-label registry of the management strategies of patients treated in the hospital for acute Heart Failure in the United States.

Detailed Description

The objective is to compile a clinical database on the strategy for the medical management of patients hospitalized with acute Heart Failure (HF). Through the use of the information collected from acute care hospitals across the United States the following information may be coming out of this study: 1) Assist hospitals in evaluating and improving quality of care for patients with acute HF by tracking quality indicators and providing benchmark data reports; 2) Describe the demographic and clinical characteristics of patients who are hospitalized with acute HF; 3) Characterize the initial emergency department evaluation and subsequent inpatient management of patients hospitalized with acute HF; 4) Identify patient characteristics and medical care practices associated with improved health outcomes in those hospitalized with acute HF; 5) Characterize trends and changes over time in the management of acute HF; 6) Offer surveillance of adherence to practice guidelines as these emerge for the inpatient management of acute HF. Observational Study - No investigational drug administered

Study Timeline

• Study Start: 2001-10
• Study Completion: 2006-02
• Study First Submitted: 2006-08-18
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-29
• Last Update Posted: 2009-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24118

Inclusion Criteria

• Age greater than or equal to 18 years at the time of admission to the hospital
• Received or is eligible to receive a principal hospital discharge diagnosis of HF
• Decompensated HF is present as determined clinically by the patient care team

Exclusion Criteria

• HF is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	Acute Decompensated Heart Failure	-

Primary Outcome Measures

Name	Time	Method
Course of care in the Emergency Department (ED) and course of care in the inpatient hospital, use of diuretics (increase urine excretion) vasodilators (relax artey and veins) and inotropeic agents (increase the function of the heart) rate of death	From admission to discharge from the hospital

Secondary Outcome Measures

Name	Time	Method
Data from patient demographics ( sex, age, gender, race)	at patients admission