Heart Failure Registry

Heart Failure, Congestive Clinical Trial

Official title:

ADHERE Core II - Acute Decompensated HEart Failure REgistry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530426
• Other study ID #: CR010513
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2007
• Last updated: January 30, 2014
• Start date: September 2001
• Est. completion date: February 2005

Study information

• Verified date: October 2007
• 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 registry is to compile a large clinical database on the medical management of patients hospitalized with acute heart failure, using information collected from acute care hospitals across the United States.

Description:

ADHERE is a phase IV, multicenter, observational, open-label registry of the management of patients treated in the hospital for acute heart failure (HF) in the United States. The target population consists of patients admitted to an acute care hospital who are treated actively for acute heart failure, where acute HF is defined as new-onset HF with decompensation; or chronic HF with decompensation. Patient eligibility is based upon the presence of an acute HF diagnosis and is not tied to the use of any specific therapeutic agent or regimen. Collect data on the episode of hospital care beginning with the point of initial care in the hospital and/or emergency department and ending with the patient's discharge, transfer out of the hospital, or in-hospital death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150000
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Received or is eligible to receive a principal hospital discharge diagnosis of HF or decompensated HF is present as determined clinically by the patient care team

Exclusion Criteria:

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scios, Inc.

References & Publications (1)

Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United Sta — View Citation