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Recruiting Not applicable

Characterization of Heart Failure With Preserved Ejection Fraction

NCT03197350 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2014-12-04
Last updated
2024-02-05

Condition(s) studied

Heart Failure, Preserved Ejection FractionCardiac FibrosisBiomarkersMagnetic Resonance Imaging

Investigational drug(s) / intervention(s)

cMRbiomarker

cMR: cardiac MRI done to complete the diagnosis

biomarker: Biomarker correlation with cMR parameters Prognostic information

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Prognosis with a follow up including HF hospitalizations and/or deaths. — 6 months
    A follow up will be done by the investigators. After that, they will determine if fibrosis estimated by cMR or biomarkers is a significant prognostic factor.

Trial sites (1)

FacilityCityRegionStatus
Cliniques universitaires Saint Luc Brussels Belgium Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03197350 on ClinicalTrials.gov ↗ ← All trials in Belgium