BREATHE Registry - I Brazilian Registry of Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Brazilian Society of Cardiology
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01428557
First received: September 1, 2011
Last updated: March 5, 2014
Last verified: March 2014
  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 [ Time Frame: follow up at 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: March 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart Failure patients
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
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: NCT01428557

Locations
Brazil
Hospital do Coracao
Sao Paulo, SP, Brazil, 04005-000
Sponsors and Collaborators
Hospital do Coracao
Brazilian Society of Cardiology
  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: March 5, 2014
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014