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BREATHE Registry - I Brazilian Registry of Heart Failure (BREATHE)

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ClinicalTrials.gov Identifier: NCT01428557
Recruitment Status : Unknown
Verified March 2014 by Hospital do Coracao.
Recruitment status was:  Active, not recruiting
First Posted : September 5, 2011
Last Update Posted : March 6, 2014
Sponsor:
Collaborator:
Brazilian Society of Cardiology
Information provided by (Responsible Party):
Hospital do Coracao

Brief Summary:
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 or disease
Heart Failure

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.


Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BREATHE Registry - I Brazilian Registry of Heart Failure
Study Start Date : March 2011
Primary Completion Date : January 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort
Heart Failure patients
Patients admitted with clinical diagnosis of decompensate heart failure, > 18 years old.



Primary Outcome Measures :
  1. Total mortality [ Time Frame: follow up at 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. Proportion of patients receiving interventions with proven benefit shown by different indicators of quality of care. [ Time Frame: follow up at 3, 6 and 12 months ]


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
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

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): NCT01428557


Locations
Brazil
Hospital do Coracao
Sao Paulo, SP, Brazil, 04005-000
Sponsors and Collaborators
Hospital do Coracao
Brazilian Society of Cardiology

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01428557     History of Changes
Other Study ID Numbers: 003/2011
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases