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Acute Decompensated Heart Failure Registry
This study is currently recruiting participants.
Verified by Janssen-Cilag Farmaceutica Ltda., December 2008
Sponsors and Collaborators: Janssen-Cilag Farmaceutica Ltda.
Scios, Inc.
Information provided by: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier: NCT00530673
  Purpose

The purpose of this multicenter observational, open-label registry is to collect data regarding the management of patients treated in the hospital for acute heart failure. The target population consists of patients admitted to an acute care hospital who are actively treated for acute heart failure, where acute heart failure is defined as: i) new-onset of heart failure with decompensation; or ii) chronic heart failure with decompensation. Patients eligibility is based upon the presence of an acute heart failure diagnosis and it is not tied to the use of specific treatment or therapeutic agent or regimen.


Condition Phase
Heart Failure, Congestive
Phase IV

MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Observational
Official Title: Acute Decompensated Heart Failure Registry

Further study details as provided by Janssen-Cilag Farmaceutica Ltda.:

Estimated Enrollment: 1000
Study Start Date: December 2007
Detailed Description:

This multicenter observational, open-label registry will compile a clinical database on the medical management of patients hospitalized and treated for acute heart failure using information collected from acute care hospitals worldwide. The target population consists of patients admitted to an acute care hospital who are actively treated for acute heart failure, where acute heart failure is defined as new-onset of heart failure with decompensation or chronic heart failure with decompensation. Patients' eligibility is based upon the presence of an acute heart failure diagnosis and it is not tied to the use of specific treatment or therapeutic agent or regimen. The study objectives are: 1) To assist hospitals in evaluating and improving quality of care for patients with acute heart failure by tracking quality indicators and providing benchmark data reports. 2) To describe the demographic and clinical characteristics of patients who are hospitalized with acute heart failure. 3) To characterize the initial emergency department evaluation and subsequent inpatient management of patients hospitalized with acute heart failure. 4) To identify patients characteristics and medical care practices associated with improved health outcomes in those hospitalized with acute heart failure. 5) To offer surveillance of adherence to practice guidelines and these emerge for the inpatient management of acute heart failure.

No drug administered

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Received or is eligible to receive a principal hospital discharge diagnosis of heart failure
  • Decompensated heart failure 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530673

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

Locations
Brazil
Pronto Socorro De Cardiologia De Pernambuco Recruiting
Recife, Brazil
Principal Investigator: Silvia Martins            
Santa Casa de Curitiba - PUCPR Recruiting
Curitiba, Brazil
Principal Investigator: Lidia Zytinski Moura            
Hospital Quinta D'Or Recruiting
Rio de Janeiro, Brazil
Principal Investigator: Humberto Vilacorta            
Hospital das Clínicas da UFG Recruiting
Goiania, Brazil
Principal Investigator: Salvador Rassi            
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Brazil
Principal Investigator: Nadine Clausell            
Universidade Estadual de Londrina Not yet recruiting
Londrina, Brazil
Principal Investigator: Manoel Canesin            
Hospital Pró-Cardíaco Recruiting
Rio de Janeiro, Brazil
Principal Investigator: Marcelo Montera            
Hospital Nossa Senhora da Conceição Recruiting
Porto Alegre, Brazil
Principal Investigator: Pedro Pimentel Filho            
Hospital Moinho de Ventos Recruiting
Porto Alegre, Brazil
Principal Investigator: Luiz Beck            
Hospital Universitário Pedro Ernesto Recruiting
Rio de Janeiro, Brazil
Principal Investigator: Denilson Oliveira            
Hcor - Hospital Do CORAÇÃO Not yet recruiting
São Paulo, Brazil
Principal Investigator: Ricardo Pavanello            
INCOR - Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP Recruiting
São Paulo, Brazil
Principal Investigator: Antonio Carlos Barreto            
Brazil, Bahia
Hospital Aliança Recruiting
Salvador, Bahia, Brazil
Principal Investigator: Fábio Villas-Boas            
Hospital Santa Izabel Recruiting
Salvador, Bahia, Brazil
Principal Investigator: Gilson Feitosa            
Brazil, Mato Grosso
Hospital Doutor JOÃO FELÍCIO Recruiting
Juiz de Fora, Mato Grosso, Brazil
Principal Investigator: Arise Galil            
Active, not recruiting
Belo Horizonte, Mato Grosso, Brazil
Brazil, São Paulo
Hospital e Maternindade Celso Pierro da Pontifícia Universidade Católica de Campinas Recruiting
Campinas, São Paulo, Brazil
Principal Investigator: José Francisco Kerr Saraiva            
Sponsors and Collaborators
Janssen-Cilag Farmaceutica Ltda.
Scios, Inc.
Investigators
Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial Janssen-Cilag Farmaceutica Ltda.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

Study ID Numbers: CR012502
Study First Received: September 13, 2007
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00530673  
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
Registry
Observational study
Acute heart failure

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009