Registry for Acute Decompensated Heart Failure Patients

This study has been completed.
Sponsor:
Information provided by:
Scios, Inc.
ClinicalTrials.gov Identifier:
NCT00366639
First received: August 18, 2006
Last updated: October 29, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Heart Failure, Congestive
Heart Decompensation
Other: Acute Decompensated Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ADHERE Core III - Acute Decompensated Heart Failure Registry

Resource links provided by NLM:


Further study details as provided by Scios, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: From admission to discharge from the hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Data from patient demographics ( sex, age, gender, race) [ Time Frame: at patients admission ] [ Designated as safety issue: No ]

Enrollment: 24118
Study Start Date: October 2001
Study Completion Date: February 2006
Groups/Cohorts Assigned Interventions
001 Other: Acute Decompensated Heart Failure
Treatment & outcomes during hospital admission for Acute DHF

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All consecutive adult patients admitted to an acute care hospital and treated actively for acute HF, where acute HF is defined clinically as a new onset with HF decompensation

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366639

Sponsors and Collaborators
Scios, Inc.
Investigators
Study Director: Scios, Inc. Clinical Trial Scios, Inc.
  More Information

No publications provided by Scios, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sr. Director, Clinical Team Leader, Scios
ClinicalTrials.gov Identifier: NCT00366639     History of Changes
Obsolete Identifiers: NCT00530673
Other Study ID Numbers: CR005194
Study First Received: August 18, 2006
Last Updated: October 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Scios, Inc.:
Heart failure, congestive
Heart decompensation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014