NCT06931015

Staging Heart Failure With Preserved Ejection Fraction

Staging Heart Failure With Preserved Ejection Fraction by Assessing Cardiac Chamber Involvement With Echocardiography

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Heart failure with preserved ejection fraction (HFpEF) is considered a systemic condition in which the prevalence of cardiovascular, metabolic, pulmonary and renal conditions determine the extent of cardiac involvement. Numerous attempts have been made to phenotype HFpEF, but patients still lack a clinically and/or prognostically relevant approach. Progressive cardiac deterioration in HFpEF appears to be associated with a worse prognosis. However, no attempt has been made to classify the extent of cardiac involvement in HFpEF. Investigators proposed the concept of HFpEF staging according to the extent of cardiac involvement identified by transthoracic echocardiography: Stage 1: isolated left ventricular involvement; Stage 2: left atrial myopathy; Stage 3: pulmonary vasculature involvement; and Stage 4: right chambers involvement. The study aims to investigate the associations between the proposed stages and clinical outcomes in HFpEF patients.

Detailed description

HFpEF is a major global public health concern due to increasing incidence and prevalence, poor prognosis and limited availability of disease-modifying therapy. The management of HFpEF and the development of novel treatments are complicated due to the heterogeneous nature of the disease, which presents multiple clinical phenotypes. Each is characterised by a unique combination of cardiac and non-cardiac comorbidities such as hypertension, obesity, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease and others. Numerous attempts have been made to phenotype HFpEF, but patients still lack a clinically and/or prognostically relevant approach. Looking beyond the phenotypes, HFpEF is considered a systemic condition in which the prevalence of cardiovascular, metabolic, pulmonary and renal conditions determine the extent of cardiac involvement. Progressive cardiac deterioration in HFpEF appears to be associated with a worse prognosis. However, no attempt has been made to classify the extent of cardiac involvement in HFpEF. Investigators proposed the concept of HFpEF staging according to the extent of cardiac involvement identified by transthoracic echocardiography (TTE), which includes four stages: Stage 1: isolated left ventricular involvement; Stage 2: left atrial myopathy; Stage 3: pulmonary vasculature involvement; and Stage 4: right chambers involvement. Emerging data suggest that every subsequent cardiac chamber deterioration could be of prognostic value. The study aims to investigate the associations between the proposed stages and clinical outcomes in HFpEF patients.

Conditions

• Heart Failure With Preserved Ejection Fraction
• Cardiovascular Diseases
• Heart Failure

Interventions

Type	Name	Description
OTHER	No interventions	No interventions

Timeline

• Start date: 2025-04-20
• Primary completion: 2028-04-13
• Completion: 2028-12-13
• First posted: 2025-04-16
• Last updated: 2025-04-20

Locations

1 site across 1 country: Russia