Heart Failure With Preserved Ejection FractionStageHFpEFNCT06931015
Staging Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction and Cardiovascular Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Cardiovascular Diseases, Heart Failure
- How many people
- 700 participants
- Where
- 1 siteRussia
- Study dates
- 20 Apr 2025to 13 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HFpEF, male and female, 40 years old and over who meet eligibility criteria.
Who may be able to join
- ≥ 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:
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- 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 join
- Any prior measurements of LVEF <50%
- 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
- Elective PCI or atrial fibrillation ablation within 30 days before visit
- Moderate and severe valve stenosis and more than mild primary valve regurgitation
- Acute myocardial infarction in the last 3 months, cardiac surgery, pulmonary embolism or cerebrovascular accident within the last six months
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- Candidates for heart transplantation
- Secondary hypertension
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
- Any active cancer
- Infective endocarditis
- Alcoholic cirrhosis
- End-stage kidney disease
- Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Svetlana Rachina contact
Russia1 site
A Shchendrygina
Moscow, 119415
Anastasia Shchendrygina, 89262309207, a.shchendrygina@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- No interventions
- Keywords
- HFpEF, Staging, Classification, Echocardiography
- Medical subject headings
- Cardiovascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No interventions | |
| HFpEF Stage 2: Left atrial myopathy | Stage 1 criteria, plus:
* LAVI >34 ml/m2, if sinus rhythm or
* AF Receives: Other: 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 Receives: Other: 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) Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of composite endpoint of all-cause death or HF hospitalisation
Measured in months
Measured: From randomisation to end of 12 months follow-up
Secondary outcomes (4)
Number of all-cause deaths, Cardiovascular (CV) deaths, HF hospitalisations or urgent HF visits
Measured as count of event
Measured: From randomisation to end of 12 months follow-up
Time to occurrence of all-cause death
Measured in months
Measured: From randomisation to end of 12 months follow-up
Time to occurrence of CV death
Measured in months
Measured: From randomisation to end of 12 months follow-up
Time to first HF hospitalisation or urgent HF Visit
Measured in months
Measured: From randomisation to end of 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion13 Apr 2028 (estimated)
- Study completion13 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anastasia Shchendrygina, Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931015
- Sponsor's protocol ID
- 05-22
- Acronym
- StageHFpEF
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging Heart Failure With Preserved Ejection Fraction by Assessing Cardiac Chamber Involvement With Echocardiography
- ClinicalTrials.gov ID
- NCT06931015
- Acronym / sponsor ID
- StageHFpEF / 05-22
- Keywords
- HFpEF, Staging, Classification, Echocardiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 13 Apr 2028 (estimated)
- Study completion
- 13 Dec 2028 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HFpEF Stage 1: Isolated left ventricle involvement | – | Other: No interventionsEstablished 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 |
| HFpEF Stage 2: Left atrial myopathy | – | Other: No interventionsStage 1 criteria, plus: * LAVI >34 ml/m2, if sinus rhythm or * AF |
| HFpEF Stage 3: Pulmonary vasculature involvement | – | Other: No interventionsStage 1-2 criteria, plus: * Pulmonary artery systolic pressure (PASP) >35 mmHg and/or * Tricuspid regurgitation (TR) velocity >2.8 m/s |
| HFpEF Stage 4: Right chambers involvement | – | Other: No interventionsStage 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) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HFpEF, male and female, 40 years old and over who meet eligibility criteria.
Key inclusion criteria (16 listed)
- ≥ 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:
- Structural and/or functional abnormalities of heart, at least one of the following:
Key exclusion criteria (14 listed)
- Any prior measurements of LVEF <50%
- 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
- Elective PCI or atrial fibrillation ablation within 30 days before visit
- Moderate and severe valve stenosis and more than mild primary valve regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions | Other | HFpEF Stage 1: Isolated left ventricle involvement, HFpEF Stage 2: Left atrial myopathy, HFpEF Stage 3: Pulmonary vasculature involvement, HFpEF Stage 4: Right chambers involvement |
Primary outcome
Time to first occurrence of composite endpoint of all-cause death or HF hospitalisation
Time frame: From randomisation to end of 12 months follow-up
Measured in months
4 secondary outcomes
Number of all-cause deaths, Cardiovascular (CV) deaths, HF hospitalisations or urgent HF visits
Time frame: From randomisation to end of 12 months follow-up
Time to occurrence of all-cause death
Time frame: From randomisation to end of 12 months follow-up
Time to occurrence of CV death
Time frame: From randomisation to end of 12 months follow-up
Time to first HF hospitalisation or urgent HF Visit
Time frame: From randomisation to end of 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- The publication which define the concept of Staging Heart Failure with Preserved Ejection Fraction by Assessing Cardiac Chamber InvolvementLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Svetlana Rachina contact
Anastasia Shchendrygina principal investigator
Sechenov University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Cardiovascular Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Shchendrygina (+79262309207, a.shchendrygina@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first occurrence of composite endpoint of all-cause death or HF hospitalisation (time frame: From randomisation to end of 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.