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Not yet recruiting NCT07534163

III Brazilian Registry of Heart Failure

Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

BREATHE III - THIRD PHASE OF THE BRAZILIAN HEART FAILURE REGISTRY

Overview

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.

Primary outcome measures

  • All-cause mortality [Time frame: 12 months]
Secondary outcome measures (7)
  • Length of hospital stay [Time frame: 12 months]
  • Composite outcome of death and rehospitalization [Time frame: 12 months]
  • General rehospitalization, rehospitalization due to heart failure and emergency visits [Time frame: 12 months]
  • Cardiovascular death [Time frame: 12 months]
  • Composite outcome of cardiovascular death and rehospitalization due to heart failure [Time frame: 12 months]
  • Proportion of patients receiving interventions with proven benefit demonstrated by different indicators of quality of care (at target dose) [Time frame: 12 months]
  • Quality of life according to the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • DE Albuquerque DC, DE Barros E Silva PGM, Lopes RD, Hoffmann-Filho CR, Nogueira PR, Reis H, Nishijuka FA, Martins SM, DE Figueiredo Neto JA, Pavanello R, DE Souza Neto JD, Danzmann LC, Gemelli JR, Rohde LEP, Hernandes ME, Rivera MAM, Simoes MV, Dos Santos ES, Canesin MF, Zilli AC, Santos RHN, Jesuino IA, Mourilhe-Rocha R, Moura LZ, Marcondes-Braga FG, Mesquita ET; BREATHE INVESTIGATORS. In-Hospita PMID 37648061

Identifiers

NCT: NCT07534163 · BREATHE III

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗