Under construction – not a live service
Sign in
Not yet taking people in RussiaNo phase

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

Studies how heart ultrasound stages relate to outcomes in adults with HFpEF.

Key facts

Who runs it
I.M. Sechenov First Moscow State Medical University
Where
Moscow, RussiaSee the site
Trial code
Registry title
Staging Heart Failure With Preserved Ejection Fraction
Status
Not yet recruiting
People taking part
700 people, planned
Started
20 Apr 2025
Expected to end
13 Dec 2028
Type of study
Observational, 4 groups
Treatments tested
  • No interventions
Record updated
20 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 or older with heart failure and a preserved ejection fraction (the heart pumps out more than 50% of its blood). It compares the stage of heart involvement seen on echocardiography with health outcomes.

Age
40 years or older
Sex
Men and women
Disease stage
Heart failure symptoms in NYHA class II-III. Left ventricular ejection fraction above 50% on echocardiography at screening. Heart structure or function abnormalities on echocardiography.
Earlier treatment
If you take oral loop diuretics, the dose must be stable.
Biomarker or test result
NT-proBNP of 300 pg/mL or more (600 pg/mL or more with atrial fibrillation) at screening. Or earlier confirmed heart failure with a hospital stay for decompensation more than 30 days before screening.

Main reasons for not taking part

  • Any earlier ejection fraction measurement below 50%
  • Infiltrative or hypertrophic cardiomyopathy, active myocarditis, or pericardial constriction
  • Moderate or severe valve narrowing, or more than mild primary valve leakage
  • Heart attack in the last 3 months, or cardiac surgery, pulmonary embolism or stroke in the last six months
  • Any active cancer, end-stage kidney disease, or alcoholic cirrhosis

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • ≥ 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

Who cannot take part

  • 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

Where in Russia

  • A ShchendryginaMoscow, RussiaContact: Anastasia ShchendryginaNo longer taking part

About the trial

What the trial wants to find out

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

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.

The 4 groups in the trial

  • HFpEF Stage 1: Isolated left ventricle involvement

    Established if patients meet the criteria of Stage 1, according to the proposed classification, which are: * LVMI \>115 g/m2 in men/ and \>95 g/m2 in women or * Relative wall thickness (RWT) \>0.42 or * Elevated LV filling pressures at rest (E/e' \>9) doi.org/10.15420/ecr.2024.31

    Treatment: No interventions

  • HFpEF Stage 2: Left atrial myopathy

    Stage 1 criteria, plus: * LAVI \>34 ml/m2, if sinus rhythm or * AF

    Treatment: No interventions

  • HFpEF Stage 3: Pulmonary vasculature involvement

    Stage 1-2 criteria, plus: * Pulmonary artery systolic pressure (PASP) \>35 mmHg and/or * Tricuspid regurgitation (TR) velocity \>2.8 m/s

    Treatment: No interventions

  • HFpEF Stage 4: Right chambers involvement

    Stage 1-3 criteria, plus: * Fractional area change (FAC) \<35% or * S' \<9.5 cm/s and/or * Tricuspid annular plane systolic excursion (TAPSE) \<17 mm and/or * Right atria (RA) volume index (\>39 ml/m2 in men/ \>33 ml/m2 for women)

    Treatment: No interventions

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Staging Heart Failure With Preserved Ejection Fraction by Assessing Cardiac Chamber Involvement With Echocardiography
Plain-language title
Ultrasound staging of heart strain in heart failure with preserved ejection fractionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 April 2025