NCT01428557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,013

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

8.3 years

First QC Date

September 1, 2011

Last Update Submit

September 19, 2022

Conditions

Heart Failure

Keywords

Heart FailureEpidemiologyEvidence-Based Practice

Outcome Measures

Primary Outcomes (1)

  • Total mortality

    follow up at 3, 6 and 12 months

Secondary Outcomes (1)

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

    follow up at 3, 6 and 12 months

Study Arms (2)

Heart Failure patients (Breathe I)

Patients admitted with clinical diagnosis of decompensate heart failure, \> 18 years old.

Heart Failure patients (Breathe Extension)

Patients admitted with clinical diagnosis of decompensate heart failure, \> 18 years old.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Public and Private Hospitals

You may qualify if:

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

You may not qualify if:

  • myocardial revascularization during last month,
  • heart failure due to sepsis,
  • acute coronary syndrome with ventricular dysfunction as reason for current hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, 04005-000, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 5, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

BR(1)