Comparing 3D and 2D heart strain measurements in heart failure patients

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 is an observational study enrolling about 419 adults with heart failure across seven Italian cardiac centers to compare left-ventricular strain measurements from 2D and 3D speckle-tracking echocardiography. Researchers will use standardized equipment and software to determine how closely the two methods agree and what factors influence any differences. The study will also explore whether 3D GLS better predicts mortality risk than 2D GLS. Inclusion requires LVEF ≤ 49% and adequate image quality; several image-acquisition limitations are excluded. No interventions are administered; the study analyzes imaging data collected during routine care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Left ventricular ejection fraction (LVEF) ≤ 49%;
* Echocardiographic image quality judged to be at least adequate according to a four-point visual image quality scale (good, adequate, poor, or inadequate)

Exclusion Criteria:

* Inability to maintain the correct position for acquiring echocardiographic images;
* Arrhythmias that make multi-beat acquisition impossible (if required), such as frequent extrasystoles (supraventricular or ventricular) and atrial fibrillation;
* Failure to visualize more than 2 segments of the left ventricle (LV), or inability to assess more than 3 segments during 3D GLS analysis;
* Failure to sign the informed consent form and inability of the participant to understand the objectives of the study

Where it's running

• ICS Maugeri - Istituto di Bari
  Bari, Ba, Italy Recruiting
• ICS Maugeri - Istituto di Milano
  Milan, Mi, Italy Recruiting
• ICS Maugeri - Istituto di Pavia
  Pavia, Pv, Italy Recruiting
• ICS Maugeri Torino
  Torino, To, Italy Recruiting
• ICS Maugeri - Istituto di Veruno
  Veruno, Italy Recruiting

Study contacts

• Study coordinator: Oronzo Catalano, MD
• Email: oronzo.catalano@icsmaugeri.it
• Phone: +39(0)382592608

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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.