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Clinical Trials in Italy / NCT07741305
Recruiting Observational

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 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Phase
Observational
Started
2026-01-08
Last updated
2026-08-19

Condition(s) studied

Heart Failure

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Bland-Altman mean difference (bias) and the limits of agreement (LOA) in comparison with a clinically acceptable range (±6.5%) — At baseline
    Bias and the LOA will be compared with a clinically acceptable range (±6.5%)

Trial sites (5)

FacilityCityRegionStatus
ICS Maugeri - Istituto di Bari Bari BA Recruiting
ICS Maugeri - Istituto di Milano Milan MI Recruiting
ICS Maugeri - Istituto di Pavia Pavia PV Recruiting
ICS Maugeri Torino Torino TO Recruiting
ICS Maugeri - Istituto di Veruno Veruno Italy Recruiting

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Other trials for the same condition

Remote Monitoring and Optimization of Heart Failure Therapy Starting soon
AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation Starting soon
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
RAPIDE: The Feasibility of a Hybrid Care Model Starting soon
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07741305 on ClinicalTrials.gov ↗ ← All trials in Italy