NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Comparison of Three-dimensional and Two-dimensional Left Ventricle Strain With Speckle-tracking Echocardiography in Heart Failure With Reduced and Mildly Reduced Ejection Fraction

NCT07741305

RecruitingN/A

Sponsor: Istituti Clinici Scientifici Maugeri SpA

Conditions: Heart Failure

Countries: Italy

This study will compare two ultrasound techniques, 2D and 3D speckle-tracking echocardiography, for measuring how well the heart muscle contracts in patients with heart failure and reduced pumping function. While 2D global longitudinal strain (GLS) is widely used and has proven value in predicting outcomes, 3D GLS may provide a more complete assessment of heart function. Researchers will enroll 419 patients from seven cardiac rehabilitation hospitals in Italy and analyze heart ultrasound images using standardized equipment and software. The study will assess how closely 2D and 3D GLS measurements agree, identify factors that influence any differences, and determine whether 3D GLS better predicts the risk of death than 2D GLS.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (5)

Bari, BA, Italy
Milan, MI, Italy
Pavia, PV, Italy
Torino, TO, Italy
Veruno, Italy