Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT03197350

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

730 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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...

  • Adults aged 18 to 99 years
  • Patients with typical symptoms and signs of heart failure
  • New York Heart Association (NYHA) functional class II or higher
  • N-terminal pro-B type natriuretic peptide (NT-proBNP) level above 350 pg/mL or hospitalization for heart failure within the last 12 months
  • Left ventricular ejection fraction (LVEF) of 50% or higher with signs of diastolic dysfunction (e.g., left atrial volume > 34 ml/m2, E/e' ratio > 14, tricuspid regurgitation velocity > 2.8 m/s, septal e' velocity < 7 cm/s, or lateral e' velocity < 10 cm/s)
  • Controls without a history of heart failure or previous cardiovascular disease will also be recruited
Not Eligible

You will not qualify if you...

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

AI-Screening

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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

CONTACT

A

Anne Catherine Pouleur

CONTACT

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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Characterization of Heart Failure With Preserved Ejection Fraction | DecenTrialz