Status:
NOT_YET_RECRUITING
Staging Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Heart Failure With Preserved Ejection Fraction
Cardiovascular Diseases
Eligibility:
All Genders
40+ years
Brief 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 c...
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 developm...
Eligibility Criteria
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:
- 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:
- 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
- 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
- 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).
Key Trial Info
Start Date :
April 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 13 2028
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06931015
Start Date
April 20 2025
End Date
December 13 2028
Last Update
April 20 2025
Active Locations (1)
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1
A Shchendrygina
Moscow, Russia, 119415