Evaluating Heart Stiffness in Elderly Patients with Diastolic Heart Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess myocardial stiffness in elderly patients suffering from isolated diastolic heart failure using a novel noninvasive imaging technique called ultrafast ultrasound. The approach utilizes ultrasonic radiation pressure to create a quantitative map of tissue elasticity, which can provide insights into heart function. By focusing on diastolic rigidity, the study seeks to improve diagnostic accuracy for heart failure, which is often challenging in clinical practice. The technology has been validated in experimental models and aims to offer a reliable diagnostic tool for clinicians.

Why it matters

Who can join: the full rules

General inclusion criteria:

* Subjects who have received information about the study and signed the informed consent form.
* Beneficiary of a social security scheme.
* Age ≥18 years.
* Hospitalization in a cardiology department.

Specific inclusion criteria:

HFpEF group (preserved left ventricular ejection fraction):

* Left ventricular ejection fraction (LVEF) ≥50%.
* BNP ≥35 pg/mL or NT-proBNP ≥135 pg/mL.
* At least one of the following:

  * Echocardiographic structural alteration: left atrial dilatation (biplane volume ≥34 mL/m²) or left ventricular hypertrophy (LV mass index ≥115 g/m² in men or ≥95 g/m² in women).
  * Echocardiographic functional alteration: criteria of diastolic dysfunction including E \>50 cm/s, mean septal-lateral e' \<9 cm/s, E/e' ≥13, or peak tricuspid regurgitation velocity ≥2.8 m/s.
* For 25 patients: documented cardiac amyloidosis.

HFmrEF group (moderately reduced left ventricular ejection fraction):

* LVEF between 40% and 49%.
* BNP ≥35 pg/mL or NT-proBNP ≥135 pg/mL.
* At least one of the following:

  * Echocardiographic structural alteration: left atrial dilatation (biplane volume ≥34 mL/m²) or left ventricular hypertrophy (LV mass index ≥115 g/m² in men or ≥95 g/m² in women).
  * Echocardiographic functional alteration: criteria of diastolic dysfunction including mean septal-lateral e' \<9 cm/s, E/e' ≥13, or peak tricuspid regurgitation velocity ≥2.8 m/s.

HFrEF group (reduced left ventricular ejection fraction):

\- Diagnosis of heart failure with reduced ejection fraction according to the ESC Guidelines.

* Presence of symptoms of heart failure.
* Presence of clinical signs of heart failure.
* LVEF \<40%.

General exclusion criteria:

* Pregnancy.
* Poor echogenicity.
* Allergy to echocardiography gel.

Specific exclusion criteria:

HFpEF group:

* Associated pulmonary disease.
* Regional wall motion abnormality.

HFmrEF group:

\- Associated pulmonary disease.

Where it's running

• Emmanuel MESSAS
  Paris, France Recruiting

Study contacts

• Principal investigator: Emmanuel MESSAS, MD — Hopital Européen Georges Pompidou
• Study coordinator: Emmanuel MESSAS, MD
• Email: emmanuel.messas@aphp.fr
• Phone: 33 6 65 03 85 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.