Staging Heart Failure With Preserved Ejection Fraction

Launched by I.M. SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on a condition called heart failure with preserved ejection fraction (HFpEF). HFpEF occurs when the heart isn’t able to pump blood effectively, even though the pumping ability (measured as ejection fraction) remains normal. The researchers want to better understand this condition by categorizing it into different stages based on how much of the heart is affected. They hope that by doing this, they can find links between these stages and how well patients do over time.

To be eligible for the trial, participants need to be at least 40 years old and have symptoms of heart failure, such as shortness of breath. They must also have a documented ejection fraction greater than 50%. Certain other heart-related tests and conditions will be considered as well. If you join the trial, you can expect to undergo heart imaging tests and possibly have your condition monitored over time. The trial is not yet recruiting participants, but it aims to gather important information that could improve understanding and treatment of HFpEF in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥ 40 years of age, male and female
• • 2. Heart failure symptoms, New York Heart Association (NYHA) II- III
• • 3. Left ventricular ejection fraction (LVEF) \> 50% documented by echocardiography at screening
• 4. 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)
• 5. 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
• • 6. Stable doses of oral loop diuretics, if prescribed
• • 7. Ability to provide informed consent
• Exclusion Criteria:
• • 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).