Registry for Acute Decompensated Heart Failure Patients

Heart Failure, Congestive Clinical Trial

Official title:

ADHERE Core III - Acute Decompensated Heart Failure Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366639
• Other study ID #: CR005194
• Status: Completed
• Phase: N/A
• First received: August 18, 2006
• Last updated: October 29, 2009
• Start date: October 2001
• Est. completion date: February 2006

Study information

• Verified date: October 2009
• 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 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.

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

Other known NCT identifiers

• NCT00530673

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24118
• Est. completion date: February 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 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure
• Heart Failure, Congestive

Intervention

Other:
• Acute Decompensated Heart Failure
Treatment & outcomes during hospital admission for Acute DHF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scios, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Data from patient demographics ( sex, age, gender, race)		at patients admission	No