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Registry for Acute Decompensated Heart Failure Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00366639
First Posted: August 21, 2006
Last Update Posted: November 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Scios, Inc.
  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 ]

Secondary Outcome Measures:
  • Data from patient demographics ( sex, age, gender, race) [ Time Frame: at patients admission ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366639


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

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
First Submitted: August 18, 2006
First Posted: August 21, 2006
Last Update Posted: November 2, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases