Registry for Acute Decompensated Heart Failure Patients - Full Text View

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:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Kociol RD, Hammill BG, Fonarow GC, Klaskala W, Mills RM, Hernandez AF, Curtis LH. Generalizability and longitudinal outcomes of a national heart failure clinical registry: Comparison of Acute Decompensated Heart Failure National Registry (ADHERE) and non-ADHERE Medicare beneficiaries. Am Heart J. 2010 Nov;160(5):885-92. doi: 10.1016/j.ahj.2010.07.020.

Maisel AS, Peacock WF, McMullin N, Jessie R, Fonarow GC, Wynne J, Mills RM. Timing of immunoreactive B-type natriuretic peptide levels and treatment delay in acute decompensated heart failure: an ADHERE (Acute Decompensated Heart Failure National Registry) analysis. J Am Coll Cardiol. 2008 Aug 12;52(7):534-40. doi: 10.1016/j.jacc.2008.05.010.

Kamath SA, Drazner MH, Wynne J, Fonarow GC, Yancy CW. Characteristics and outcomes in African American patients with decompensated heart failure. Arch Intern Med. 2008 Jun 9;168(11):1152-8. doi: 10.1001/archinte.168.11.1152.

Peacock WF 4th, De Marco T, Fonarow GC, Diercks D, Wynne J, Apple FS, Wu AH; ADHERE Investigators. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008 May 15;358(20):2117-26. doi: 10.1056/NEJMoa0706824.

Fonarow GC, Peacock WF, Horwich TB, Phillips CO, Givertz MM, Lopatin M, Wynne J; ADHERE Scientific Advisory Committee and Investigators. Usefulness of B-type natriuretic peptide and cardiac troponin levels to predict in-hospital mortality from ADHERE. Am J Cardiol. 2008 Jan 15;101(2):231-7. doi: 10.1016/j.amjcard.2007.07.066. Epub 2007 Dec 3.

Hauptman PJ, Goodlin SJ, Lopatin M, Costanzo MR, Fonarow GC, Yancy CW. Characteristics of patients hospitalized with acute decompensated heart failure who are referred for hospice care. Arch Intern Med. 2007 Oct 8;167(18):1990-7.

Fonarow GC, Peacock WF, Phillips CO, Givertz MM, Lopatin M; ADHERE Scientific Advisory Committee and Investigators. Admission B-type natriuretic peptide levels and in-hospital mortality in acute decompensated heart failure. J Am Coll Cardiol. 2007 May 15;49(19):1943-50. Epub 2007 Apr 30.


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 September 28, 2016