Characterization of Heart Failure With Preserved Ejection Fraction
Recruiting · NCT03197350 · Interventional (participants receive a specific treatment) · Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Cliniques universitaires Saint Luc - Brussels, Belgium