NCT06931015Not yet recruiting
Staging Heart Failure With Preserved Ejection Fraction
Staging Heart Failure With Preserved Ejection Fraction by Assessing Cardiac Chamber Involvement With Echocardiography
Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 9 Apr 2025
- Start date
- 20 Apr 2025
- Primary completion date
- 13 Apr 2028
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Diseases
- Heart failure
- NCT number
- NCT06931015
What you commit to
- Study type: Observational
- Planned participants: 700
- From 20 Apr 2025 to the primary completion date, 13 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Elective PCI or atrial fibrillation ablation within 30 days before visit
Other illness
- 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).
Lab values
- Any prior measurements of LVEF \<50%
Other
- Moderate and severe valve stenosis and more than mild primary valve regurgitation
- Infective endocarditis
- Alcoholic cirrhosis
Who the study is looking for
- ≥ 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| A Shchendrygina Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.