NCT03197350 Characterization of Heart Failure With Preserved Ejection Fraction
| NCT ID | NCT03197350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| Condition | Heart Failure, Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2014-12-04 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2014-12-04 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goals of this research will be to define some of the mechanisms underlying the progression and complications of heart failure (HF) with preserved left ventricular ejection fraction (HFPEF) Aim 1: to evaluate the differences in cardiac structure, function and fibrosis markers through the spectrum of HF stages in order to deepen the understanding of the pathophysiology driving HF progression. Aim 2: to define the mechanisms by which HF risk factors, such as hypertension, diabetes, obesity, and renal insufficiency, interact with age to increase HF risk, and to evaluate the role of precipitating factors such as myocardial ischemia, atrial fibrillation in HFPEF. Aim 3: to determine prognostic factors in HFPEF patients, by following these patients over time. Accordingly the investigators will correlate baseline data (echocardiographic, MRI or biomarkers) with incident cardiovascular events and determine whether these measures provide incremental prognostic information beyond clinical characteristics.
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
Contact & Investigator
Anne Catherine Pouleur
PRINCIPAL INVESTIGATOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Frequently Asked Questions
Who can join the NCT03197350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Heart Failure, Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03197350 currently recruiting?
Yes, NCT03197350 is actively recruiting participants. Contact the research team at anne-catherine.pouleur@uclouvain.be for enrollment information.
Where is the NCT03197350 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT03197350 clinical trial?
NCT03197350 is sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. The principal investigator is Anne Catherine Pouleur at Cliniques universitaires Saint-Luc- Université Catholique de Louvain. The trial plans to enroll 500 participants.
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