Ultrasound staging of heart strain in heart failure with preserved ejection fraction

Trial details

Who runs it

I.M. Sechenov First Moscow State Medical University

Trial code

NCT06931015

Record updated

20 April 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: ≥ 40 years of age, male and female; Heart failure symptoms, New York Heart Association (NYHA) II- III; Left ventricular ejection fraction (LVEF) > 50% documented by echocardiography at screening; One of the following scenarios:; At screening, N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/mL (sinus rhythm) or ≥600 pg/mL (if AF) and echocardiographic criteria see #5; Previously confirmed HFpEF in combination with a history of hospitalization for HFpEF decompensation >30 days before screening defined as the presence of dyspnea and 2 of the following:; Rales on chest auscultation or sings of congestion on X-ray/CT scan; Peripheral Oedema; Elevated NT-proBNP ≥300 pg/mL (sinus rhythm) or ≥600 pg/mL (if AF); Structural and/or functional abnormalities of heart, at least one of the following:; Left atrial volume index (LAVI) >34 mL/m2 (if AF >40 mL/m2); Left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females; Relative wall thickness > 0.42; E/e' ratio at rest >9; Stable doses of oral loop diuretics, if prescribed; Ability to provide informed consent.

Exclusion: Elective PCI or atrial fibrillation ablation within 30 days before visit; Established diagnosis of infiltrative (amyloidosis etc.), hypertrophic cardiomyopathy, muscular dystrophies, complex congenital heart disease, active myocarditis or pericardial constriction; Planned interventions, including major cardiac surgery, percutaneous coronary intervention (PCI), transcatheter aortic valve implantation (TAVI), or implantation of cardiac resynchronization therapy; Acute myocardial infarction in the last 3 months, cardiac surgery, pulmonary embolism or cerebrovascular accident within the last six months; Candidates for heart transplantation; Secondary hypertension; Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease; Any active cancer; End-stage kidney disease; Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism); Any prior measurements of LVEF <50%; Moderate and severe valve stenosis and more than mild primary valve regurgitation; Infective endocarditis; Alcoholic cirrhosis.

ClinicalTrials.gov NCT06931015