III Brazilian Registry of Heart Failure

NCT07534163 | Not Yet Recruiting

• 1 other identifier: BREATHE III
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  All cases of death

  12 months

Secondary Outcomes (7)

• Length of hospital stay

  12 months

• Composite outcome of death and rehospitalization

  12 months

• General rehospitalization, rehospitalization due to heart failure and emergency visits

  12 months

• Cardiovascular death

  12 months

• Composite outcome of cardiovascular death and rehospitalization due to heart failure

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include adult patients (≥18 years) admitted to public and private hospitals in Brazil with acute heart failure-related presentations. Eligible participants comprise two main groups: (1) patients hospitalized for acute myocardial infarction (AMI) who develop newly identified left ventricular systolic dysfunction during hospitalization (LVEF ≤40), limited to up to 25% of the total study population; and (2) patients admitted with a primary diagnosis of decompensated heart failure, regardless of ejection fraction, defined according to the universal criteria for heart failure. In patients with heart failure with preserved ejection fraction (HFpEF), additional characterization will include H2FPEF and HFA-PEFF scores. Patients will be excluded if they decline participation during the informed consent process, have undergone surgical myocardial revascularization within the previous month, present with heart failure secondary to sepsis, or are admitted with cardiogenic shock.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead
• Brazilian Society of Cardiology: collaborator

Related Publications (1)

• 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-Hospital Management and Long-term Clinical Outcomes and Adherence in Patients With Acute Decompensated Heart Failure: Primary Results of the First Brazilian Registry of Heart Failure (BREATHE). J Card Fail. 2024 May;30(5):639-650. doi: 10.1016/j.cardfail.2023.08.014. Epub 2023 Aug 28.

  PMID: 37648061 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

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

CONTACT

113889-3939; pgmelo@hcor.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04