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NCT Number: NCT07534163

III Brazilian Registry of Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 12 months

    All cases of death

Secondary outcomes

  1. Length of hospital stay

    Time frame: 12 months

    Duration of hospitalization

  2. Composite outcome of death and rehospitalization

    Time frame: 12 months

    Death or new hospitalization during follow-up

  3. General rehospitalization, rehospitalization due to heart failure and emergency visits

    Time frame: 12 months

    All-cause of rehospitalization, rehospitalization due to heart failure and emergency visits

  4. Cardiovascular death

    Time frame: 12 months

    Death due to cardiovascular causes

  5. Composite outcome of cardiovascular death and rehospitalization due to heart failure

    Time frame: 12 months

    Death to cardiovascular cause or rehospitalization due to heart failure

  6. Proportion of patients receiving interventions with proven benefit demonstrated by different indicators of quality of care (at target dose)

    Time frame: 12 months

    Percentage of patients receiving guideline-directed therapies

  7. Quality of life according to the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Time frame: 12 months

    Assessment of Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Pedro Gabriel M de Barros e Silva, MD, MHS, PhD

CONTACT

[email protected]

113889-3939

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Collaborators

  • Brazilian Society of Cardiology

Registry information

Official study title

BREATHE III - THIRD PHASE OF THE BRAZILIAN HEART FAILURE REGISTRY

Acronym: BREATHE III

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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