Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
ID03197350

Characterization of Heart Failure With Preserved Ejection Fraction

Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2024-02-05

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the mechanisms behind heart failure with preserved left ventricular ejection fraction (HFpEF), a common and complex form of heart failure that affects more than half of all heart failure cases. This study aims to understand how heart structure, function, and fibrosis markers change across different stages of heart failure, and how risk factors like hypertension, diabetes, obesity, and kidney problems affect the disease progression. Researchers also want to identify factors that predict outcomes for HFpEF patients by following them over time and comparing clinical data with heart imaging and biomarkers. The study involves three groups: patients with HFpEF, patients with heart failure with reduced ejection fraction (HFrEF), and healthy control subjects without heart disease. Eligible heart failure patients must be 50 years or older, have specific heart function measurements, symptoms, and recent hospitalization or elevated heart-related biomarkers. Participants will undergo cardiac magnetic resonance imaging (cMR) to assist diagnosis and evaluate heart structure and function. Control subjects will be recruited across different age decades and will have no heart risk factors or abnormalities on heart tests. Participants will be followed to assess their prognosis, including heart failure hospitalizations or deaths over a six-month period. The study collects data through imaging tests like echocardiography and MRI, blood biomarkers, and clinical evaluations to understand heart failure progression. Researchers will monitor heart function and health outcomes to determine how well imaging and biomarker measures predict future cardiovascular events. The total study duration spans several years, beginning in 2014 and ending in 2028.

CONDITIONS

Brief Title

Characterization of Heart Failure With Preserved Ejection Fraction

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Controls must have no history of heart failure or previous cardiovascular disease
  • Patients must have typical symptoms and signs of heart failure with New York Heart Association class II or higher
  • Patients must have NT-proBNP levels greater than 350 pg/mL or have been hospitalized for heart failure within the previous 12 months
  • Patients with heart failure with reduced ejection fraction must have LVEF below 40%
  • Patients with heart failure with preserved ejection fraction must have LVEF of 50% or higher with signs of diastolic dysfunction
  • Participants must be aged between 18 and 99 years old
Not Eligible

You will not qualify if you...

  • Severe valvular heart disease
  • Infiltrative or hypertrophic cardiomyopathy
  • Acute coronary syndrome within the last 30 days
  • Chronic obstructive pulmonary disease classified as GOLD 3 or 4
  • Congenital heart disease
  • Pericardial disease
  • Terminal renal failure with eGFR below 15 mL/min/1.73m² or requiring dialysis
  • Atrial fibrillation with ventricular response over 140 bpm
  • Severe anemia with hemoglobin below 8 g/dL
  • Liver dysfunction
  • Active or evolving cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo cardiac MRI (cMR) and biomarker assessments to complete diagnosis and correlate prognostic information.

1 to 2 visits depending on assessments

Long-term Monitoring

Duration - 6 months

Participants are followed up to monitor heart failure hospitalizations and survival outcomes over 6 months.

Periodic follow-up visits during 6 months

Trial Site Locations

Total: 1 location

1

Cliniques universitaires Saint Luc

Brussels, Belgium

Actively Recruiting

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Research Team

A

Anne-Catherine Pouleur

A

Anne Catherine Pouleur

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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Published Research Related To This Trial

Heart failure with preserved ejection fraction shows no excess mortality in older patients: a population-matched relative survival analysis.

Christophe de Terwangne, Nassiba Menghoum, Marin Boute...

https://pubmed.ncbi.nlm.nih.gov/41495328

Exploring the impact of metabolic comorbidities on epicardial adipose tissue in heart failure with preserved ejection fraction.

Nassiba Menghoum, Maria Chiara Badii, Martin Leroy...

https://pubmed.ncbi.nlm.nih.gov/40121452

Associations and prognostic significance of diffuse myocardial fibrosis by cardiovascular magnetic resonance in heart failure with preserved ejection fraction.

Clotilde Roy, Alisson Slimani, Christophe de Meester...

https://pubmed.ncbi.nlm.nih.gov/30086783