Left Ventricular Myocardial Strain Assessed by Three-dimensional Speckle-tracking Echocardiography in Heart Failure With Reduced and Mildly Reduced Ejection Fraction. A Comparison With Two-dimensional Evaluation in a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 419
- 试验地点
- 5
- 主要终点
- Bland-Altman mean difference (bias) and the limits of agreement (LOA) in comparison with a clinically acceptable range (±6.5%)
研究概览
简要总结
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.
详细描述
Left Ventricular Myocardial Strain Assessed by Three-Dimensional Speckle-Tracking Echocardiography in Heart Failure with Reduced or Mildly Reduced Ejection Fraction: Comparison with Two-Dimensional Assessment in a Prospective Observational Study
Background
Global longitudinal strain (GLS) derived from speckle-tracking echocardiography (STE) is a robust, well-validated, and reproducible technique for assessing left ventricular (LV) longitudinal deformation and is available on most modern echocardiography systems. GLS appears to provide superior prognostic value compared with ejection fraction (EF) for predicting major adverse cardiac events across various clinical settings, including chronic heart failure (CHF).
Three-dimensional (3D) STE represents a further advancement in myocardial deformation imaging, enabling rapid and comprehensive assessment of all LV segments and measurement of global 3D GLS from a single dataset. However, in healthy individuals, reference values for 3D and 2D GLS differ significantly, likely because 3D GLS more accurately captures the complex mechanics of LV contraction, whereas 2D GLS provides higher spatial and temporal resolution.
Although 3D STE is increasingly being used to evaluate LV systolic function in patients with CHF, data regarding the agreement and differences between 2D and 3D measurements in this clinical setting remain limited. This issue is particularly relevant in patients with systolic heart failure, as reduced EF appears to weaken the correlation between 2D and 3D GLS measurements, according to available studies with relatively small sample sizes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Heart failure with reduced ejection fraction (HFrEF) or mildly reduced ejection fraction (HFmrEF)
Patients with HFrEF or EFmrEF will be assessed with 2D and 3D echocardiography to evaluate the agreement between 2D and 3D global longitudinal strain measurements
结局指标
主要结局
Bland-Altman mean difference (bias) and the limits of agreement (LOA) in comparison with a clinically acceptable range (±6.5%)
时间窗: At baseline
Bias and the LOA will be compared with a clinically acceptable range (±6.5%)
次要结局
- Covariates and Confounders(At baseline)
- Comparison of all-cause mortality by 2D and 3D global longitudinal strain(From enrollment to the end of follow-up (1 year))