Understanding heart failure with preserved ejection fraction
Official title: Characterization of Heart Failure With Preserved Ejection Fraction
Run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · NCT03197350 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Status | Recruiting |
| Started | December 4, 2014 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | February 5, 2024 |
| Trial ID | NCT03197350 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe valvular disease, infiltrative or hypertrophic cardiomyopathy, or terminal renal failure are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While heart failure research is extensive, the specific focus on HFpEF mechanisms and prognostic factors is less explored, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: anne-catherine.pouleur@uclouvain.be
- Phone: 003227646600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.