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III Brazilian Registry of Heart Failure

BREATHE III - THIRD PHASE OF THE BRAZILIAN HEART FAILURE REGISTRY

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07534163
Acronym
BREATHE III
Enrollment
2000
Registered
2026-04-16
Start date
2026-04-20
Completion date
2028-10-01
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

BREATHE III is a prospective, multicenter, observational registry designed to provide contemporary insights into the epidemiological, clinical, and prognostic characteristics of patients hospitalized with acute heart failure (AHF) in Brazil, including those with decompensated heart failure or new-onset ventricular dysfunction during acute myocardial infarction. Recent evidence, such as the STRONG-HF trial, has demonstrated the prognostic benefit of rapid initiation and up-titration of guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction (HFrEF). However, prior phases of the BREATHE registry did not evaluate the timing of therapeutic optimization or barriers to implementing these strategies. Additionally, the therapeutic landscape of heart failure has evolved substantially in recent years, with the introduction of novel pharmacological agents, expanded indications for existing therapies, and new treatment options for heart failure with preserved ejection fraction (HFpEF). BREATHE III aims to address these knowledge gaps by systematically assessing, over a 12-month follow-up, patient characteristics, treatment patterns, adherence to guideline-recommended therapies, time to treatment optimization, and clinical outcomes. The study will also identify barriers to the implementation and titration of evidence-based therapies, evaluate regional variations in care, and describe contemporary management practices across public and private healthcare settings in Brazil. The results of this registry are expected to inform strategies to improve quality of care, optimize resource allocation, and guide future interventions aimed at reducing morbidity and mortality associated with heart failure in Brazil.

Interventions

None listed

Sponsors

Hospital do Coracao
Lead SponsorOTHER
Brazilian Society of Cardiology
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients (≥ 18 years) admitted to public and private hospitals with one of the two clinical conditions below: * Admission for AMI (Acute Myocardial Infarction) presenting with reduced ejection fraction during hospitalization (LVEF ≤ 40%) and which had not been previously identified (limit of 25% of the study sample included by this criterion) * Primary diagnosis of decompensated HF (regardless of ejection fraction), with the HF diagnosis established according to the universal definition of heart failure. In cases of HF with HFpEF, in addition to the data from the universal heart failure criteria, H2FPEF and HFA PEFF data will be collected.

Exclusion criteria

* Refusal to participate in the study during the informed consent process; * Surgical myocardial revascularization in the last month; * Heart failure secondary to sepsis (sepsis as the origin of heart failure); * Cardiogenic shock.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality12 monthsAll cases of death

Secondary

MeasureTime frameDescription
Length of hospital stay12 monthsDuration of hospitalization
Composite outcome of death and rehospitalization12 monthsDeath or new hospitalization during follow-up
General rehospitalization, rehospitalization due to heart failure and emergency visits12 monthsAll-cause of rehospitalization, rehospitalization due to heart failure and emergency visits
Cardiovascular death12 monthsDeath due to cardiovascular causes
Composite outcome of cardiovascular death and rehospitalization due to heart failure12 monthsDeath to cardiovascular cause or rehospitalization due to heart failure
Proportion of patients receiving interventions with proven benefit demonstrated by different indicators of quality of care (at target dose)12 monthsPercentage of patients receiving guideline-directed therapies
Quality of life according to the Minnesota Living with Heart Failure Questionnaire (MLHFQ)12 monthsAssessment of Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Contacts

CONTACTPedro Gabriel M de Barros e Silva, MD, MHS, PhD
pgmelo@hcor.com.br113889-3939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026