Characterization of Heart Failure With Preserved Ejection Fraction

Magnetic Resonance Imaging Clinical Trial

Official title:

Characterization of Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03197350
• Other study ID #: HFpEF
• Secondary ID: 2012/23AVR/199
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2014
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Anne-Catherine Pouleur
• Phone: 003227646600
• Email: anne-catherine.pouleur[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Cardiac Fibrosis
• Heart Failure
• Heart Failure, Diastolic
• Magnetic Resonance Imaging

Intervention

Diagnostic Test:
• cMR
cardiac MRI done to complete the diagnosis

Biological:
• biomarker
Biomarker correlation with cMR parameters Prognostic information

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis with a follow up including HF hospitalizations and/or deaths.	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.	6 months