An observational study in Heart Failure With Preserved Ejection Fraction, Cardiovascular Diseases and Heart Failure, sponsored by I.M. Sechenov First Moscow State Medical University. Not yet recruiting at 1 site in Russian Federation. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by I.M. Sechenov First Moscow State Medical University · Observational
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 700 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
Compared within Heart Failure, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with HFpEF, male and female, 40 years old and over who meet eligibility criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
One of the following scenarios:
A) 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
B) 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:
Structural and/or functional abnormalities of heart, at least one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: No interventions
Stage 1 criteria, plus: * LAVI \>34 ml/m2, if sinus rhythm or * AF
Other: No interventions
Stage 1-2 criteria, plus: * Pulmonary artery systolic pressure (PASP) \>35 mmHg and/or * Tricuspid regurgitation (TR) velocity \>2.8 m/s
Other: No interventions
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)
Other: No interventions
No interventions
Time to first occurrence of composite endpoint of all-cause death or HF hospitalisation
Measured in months
Time frame: From randomisation to end of 12 months follow-up
Number of all-cause deaths, Cardiovascular (CV) deaths, HF hospitalisations or urgent HF visits
Measured as count of event
Time frame: From randomisation to end of 12 months follow-up
Time to occurrence of all-cause death
Measured in months
Time frame: From randomisation to end of 12 months follow-up
Time to occurrence of CV death
Measured in months
Time frame: From randomisation to end of 12 months follow-up
Time to first HF hospitalisation or urgent HF Visit
Measured in months
Time frame: From randomisation to end of 12 months follow-up
Plan to share: No
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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I.M. Sechenov First Moscow State Medical University →