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NCT Number: NCT03197350

Characterization of Heart Failure With Preserved Ejection Fraction

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint Luc

Brussels, Belgium

Location status: Recruiting

Location contact

Clotilde Roy

CONTACT

About this study

Heart failure (HF) is a prevalent and complex clinical syndrome characterized by significant morbidity and mortality. HF patients are classified into two major groups based on their left ventricular ejection fraction (LVEF): heart failure with reduced ejection fraction (HFrEF) (LVEF < 40%) and heart failure with preserved ejection fraction (HFpEF) (LVEF ≥ 50%). These groups exhibit distinct clinical and biological characteristics, and their underlying pathophysiology have been thoroughly investigated. However, HFpEF, which represents more than 50% of HF cases, remains a poorly understood disease with limited therapeutic options

Several proposed mechanisms contribute to the development of HFpEF, including systemic inflammation, microvascular dysfunction, cardiometabolic abnormalities, and interstitial fibrosis. The aim of our research programm is to understand the differences between the pathophysiology of this syndrome compared to that of heart failure with reduced EF, with a focus on cardiac fibrosis and metabolism.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cMR

Diagnostic Test

cardiac MRI done to complete the diagnosis

biomarker

Biological

Biomarker correlation with cMR parameters Prognostic information

Primary outcomes

  1. Prognosis with a follow up including HF hospitalizations and/or deaths.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Catherine Pouleur

CONTACT

[email protected]

0032276600

Anne-Catherine Pouleur

CONTACT

[email protected]

003227646600

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Jun 23, 2017
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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