BREATHE Registry - I Brazilian Registry of Heart Failure

This study is currently recruiting participants.
Verified September 2011 by Hospital do Coracao
Sponsor:
Collaborator:
Sociedade Brasileira de Cardiologia
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01428557
First received: September 1, 2011
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BREATHE Registry - I Brazilian Registry of Heart Failure

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • Total mortality

Secondary Outcome Measures:
  • Proportion of patients receiving interventions with proven benefit shown by different indicators of quality of care.

Estimated Enrollment: 1200
Study Start Date: March 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart Failure, Epidemiology, Evidence-Based Practice
Patients admitted with clinical diagnosis of decompensate heart failure, > 18 years old.

Detailed Description:

Background: Several local registries seek to show an isolated clinical characteristics of patients hospitalized with heart failure (HF) in hospitals and communities in Brazil. Overall, the analysis of these data suggests that there are important differences in etiology, the factors of decompensation, treatment and prognosis of HF patients in different regions.

Objectives: To evaluate the demographic, clinical, prognostics characteristics of 1,200 patients admitted with clinical diagnosis of decompensate heart failure in a group of 60 hospitals representative in different regions. Other specific objectives include describing the in-hospital mortality after admission, to describe the content and the reason for re-admission, to assess adherence to evidence-based guidelines (recommended by guidelines), to measure indicators of quality of care and establish a national registry data to allow for comparison with international records of patients admitted with ADHF.

Methods: Observational cross (record) with longitudinal follow-up where patients admitted to public and private hospitals primarily defined in IC will be studied.

  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

Public and Private Hospitals

Criteria

Inclusion Criteria:

  • > 18 years old,
  • Boston Criteria > 7,
  • patients hospitalized > 24 hours.

Exclusion Criteria:

  • myocardial revascularization during last month,
  • heart failure due to sepsis,
  • acute coronary syndrome with ventricular dysfunction as reason for current hospitalization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428557

Locations
Brazil
Hospital do Coracao Recruiting
Sao Paulo, SP, Brazil, 04005-000
Contact: Otavio Berwanger, PhD     551130536611 ext 8201     oberwanger@hcor.com.br    
Principal Investigator: Ricardo Pavanello, MD            
Sponsors and Collaborators
Hospital do Coracao
Sociedade Brasileira de Cardiologia
  More Information

No publications provided

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01428557     History of Changes
Other Study ID Numbers: 003/2011
Study First Received: September 1, 2011
Last Updated: September 2, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hospital do Coracao:
Heart Failure
Epidemiology
Evidence-Based Practice

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013