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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Patients with a diagnosis of heart failure and a reduced or mildly reduced ejection fration of left ventricle

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

419 Participants
are grouped into 1 trial group
Group A: Heart failure with reduced ejection fraction (HFrEF) or mildly reduced ejection fraction (HFmrEF)

Trial outcomes

Primary outcomes

1

Bland-Altman mean difference (bias) and the limits of agreement (LOA) in comparison with a clinically acceptable range (±6.5%)

Bias and the LOA will be compared with a clinically acceptable range (±6.5%)

Time frame
At baseline

Secondary outcomes

1

Covariates and Confounders

The factors associated with differences between 2D and 3D GLS measurements

Time frame
At baseline
2

Comparison of all-cause mortality by 2D and 3D global longitudinal strain

The area under the receiver operating characteristic curve (AUC-ROC) will be used to assess the predictive performance of 2D and 3D GLS for all-cause mortality. The DeLong test will be used to compare the AUCs of the two methods.

Time frame
From enrollment to the end of follow-up (1 year)

Other outcomes

Sponsors and contacts

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