Characterization of Heart Failure With Preserved Ejection Fraction

NCT03197350 | Recruiting

• 2 other identifiers: HFpEF2012/23AVR/199
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Preserved Ejection Fraction; Cardiac Fibrosis; Biomarkers; Magnetic Resonance Imaging

Keywords

heart failure with preserved ejection fraction; Imaging; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

HFpEF

ACTIVE COMPARATOR

We intend to recruit consecutive patients admitted for HFPEF in our institution during the next years. Eligible patients include those with age ≥50 years, LVEF ≥50%, symptomatic HF, and either a hospitalization for HF within the prior year or an elevated natriuretic peptide level (BNP ≥100 pg/mL or NT-proBNP ≥350 pg/mL) within the 60 days before inclusion. Intervention: cMR

Diagnostic Test: cMR; Biological: biomarker

Controls

ACTIVE COMPARATOR

We plan to recruit 10 per decade of age. These subjects will allow us to evaluate the effects of age on the parameters of our study. They will have no risk factors, a normal ECG at rest and normal heart ultrasound and no abnormalities on a stress test. Intervention: cMR

Diagnostic Test: cMR; Biological: biomarker

HFrEF

ACTIVE COMPARATOR

We intend to recruit consecutive patients admitted for HFrEF in our institution during the next years. Eligible patients include those with age ≥50 years, LVEF ≤40%, symptomatic HF, and either a hospitalization for HF within the prior year or an elevated natriuretic peptide level (BNP ≥100 pg/mL or NT-proBNP ≥350 pg/mL) within the 60 days before inclusion. Intervention: cMR

Diagnostic Test: cMR; Biological: biomarker

Interventions

cMR DIAGNOSTIC_TEST

cardiac MRI done to complete the diagnosis

Controls; HFpEF; HFrEF

biomarker BIOLOGICAL

Biomarker correlation with cMR parameters Prognostic information

Controls; HFpEF; HFrEF

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint Luc

Brussels, Belgium

RECRUITING

Related Publications (4)

• de Terwangne C, Menghoum N, Boute M, Lejeune S, Pasquet A, Gerber B, Vancraeynest D, Boland B, Beauloye C, Pouleur AC. Heart failure with preserved ejection fraction shows no excess mortality in older patients: a population-matched relative survival analysis. Geroscience. 2026 Jan 6. doi: 10.1007/s11357-025-02063-0. Online ahead of print.

  PMID: 41495328 DERIVED

• Menghoum N, Badii MC, Leroy M, Parra M, Roy C, Lejeune S, Vancraeynest D, Pasquet A, Brito D, Casadei B, Depoix C, Filippatos G, Gruson D, Edelmann F, Ferreira VM, Lhommel R, Mahmod M, Neubauer S, Persu A, Piechnik S, Hellenkamp K, Ikonomidis I, Krakowiak B, Pieske B, Pieske-Kraigher E, Pinto F, Ponikowski P, Senni M, Trochu JN, Van Overstraeten N, Wachter R, Gerber BL, Balligand JL, Beauloye C, Pouleur AC. Exploring the impact of metabolic comorbidities on epicardial adipose tissue in heart failure with preserved ejection fraction. Cardiovasc Diabetol. 2025 Mar 22;24(1):134. doi: 10.1186/s12933-025-02688-7.

  PMID: 40121452 DERIVED

• Lejeune S, Ginion A, Menghoum N, Vancraeynest D, Pasquet A, Gerber BL, Horman S, Beauloye C, Pouleur AC. Association of Plasma Myeloperoxidase with Inflammation and Diabetic status in HFpEF. Rev Cardiovasc Med. 2023 Feb 8;24(2):56. doi: 10.31083/j.rcm2402056. eCollection 2023 Feb.

  PMID: 39077419 DERIVED

• Roy C, Slimani A, de Meester C, Amzulescu M, Pasquet A, Vancraeynest D, Beauloye C, Vanoverschelde JL, Gerber BL, Pouleur AC. Associations and prognostic significance of diffuse myocardial fibrosis by cardiovascular magnetic resonance in heart failure with preserved ejection fraction. J Cardiovasc Magn Reson. 2018 Aug 8;20(1):55. doi: 10.1186/s12968-018-0477-4.

  PMID: 30086783 DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Anne Catherine Pouleur

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Catherine Pouleur

CONTACT

003227646600; anne-catherine.pouleur@uclouvain.be

Anne Catherine Pouleur

CONTACT

0032276600; anne-catherine.pouleur@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will compare 3 different groups: controls and HFpEF patients and HFrEF patients, in order to better understand the pathophysiology in HF with preserved ejection fraction.

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: December 4, 2014
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

BE (1)