Understanding heart failure with preserved ejection fraction

Characterization of Heart Failure With Preserved Ejection Fraction

This study looks at how different factors like age, high blood pressure, diabetes, and obesity affect heart failure with preserved ejection fraction (HFpEF) to help understand the condition better and track patients over time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (other)
• Locations: 1 site (Brussels)
• Trial ID: NCT03197350 on ClinicalTrials.gov

What this trial studies

This research aims to explore the mechanisms behind heart failure with preserved ejection fraction (HFpEF) by evaluating differences in cardiac structure, function, and fibrosis markers across various stages of heart failure. The study will investigate how risk factors like hypertension, diabetes, and obesity interact with age to influence HF risk, as well as the impact of precipitating factors such as myocardial ischemia and atrial fibrillation. Additionally, it will track HFpEF patients over time to identify prognostic factors by correlating baseline data with cardiovascular events.

Who should consider this trial

Good fit: Ideal candidates include patients with typical symptoms of heart failure, classified as NYHA functional class II or higher, and with specific NT-proBNP and echocardiographic criteria.

Not a fit: Patients with severe valvular disease, infiltrative or hypertrophic cardiomyopathy, or terminal renal failure are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of heart failure with preserved ejection fraction, potentially enhancing patient outcomes.

How similar studies have performed: While heart failure research is extensive, the specific focus on HFpEF mechanisms and prognostic factors is less explored, making this approach relatively novel.

Eligibility criteria

Controls without an history of HF and previous cardiovascular disease will be recruited

Inclusion Criteria for HF patients:

Patients need to have typical symptoms and signs of HF, New York Heart Association (NYHA) functional class II or higher, N-terminal pro-B type natriuretic peptide (NT-proBNP) \>350pg/mL, or an hospitalization for HF within the previous 12 months. Left ventricular ejection fraction (LVEF) is required to be lower than 40% in patients with HFrEF and 50% or higher in HFpEF, with evident signs of diastolic dysfunction ( LA \> 34 ml/m²; E/e' \> 14; TR \>2.8 ms, septal e' velocity \< 7 cm/s or Lateral e' velocity \<10 cm/s)

Exclusion Criteria for HF patients:

Patients with severe valvular disease, infiltrative or hypertrophic cardiomyopathy, acute coronary syndrome in the previous 30 days, chronic obstructive pulmonary disease GOLD 3 or 4, congenital heart disease, pericardial disease, terminal renal failure (eGFR \< 15mL/min/1,73m²) or subjects requiring dialysis, atrial fibrillation with a ventricular response \> 140 bpm, severe anemia (hemoglobin \< 8 g/dL), liver dysfunction, and evolving cancer will be excluded

Where this trial is running

Brussels

• Cliniques universitaires Saint Luc — Brussels, Belgium (RECRUITING)

Study contacts

• Principal investigator: Anne Catherine Pouleur — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Study coordinator: Anne-Catherine Pouleur

Conditions: Heart Failure, Preserved Ejection Fraction, Cardiac Fibrosis, Biomarkers, Magnetic Resonance Imaging, heart failure with preserved ejection fraction, Imaging, Prognosis