BREATHE Registry - I Brazilian Registry of Heart Failure

Heart Failure Clinical Trial

— BREATHE  

Official title:

BREATHE Registry - I Brazilian Registry of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428557
• Other study ID #: 003/2011
• Status: Completed
• Start date: March 2011
• Est. completion date: September 2019

Study information

• Verified date: September 2022
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3013
• Est. completion date: September 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Brazil	Hospital do Coracao	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Brazilian Society of Cardiology

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total mortality		follow up at 3, 6 and 12 months
Secondary	Proportion of patients receiving interventions with proven benefit shown by different indicators of quality of care.		follow up at 3, 6 and 12 months