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 | Recruiting

• 1 other identifier: CTSM165-25
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Heart Failure

Keywords

Myocardial strain; Speckle-Tracking Echocardiography; Heart failure with reduced ejection fraction (HFrEF); Heart failure with mildly reduced ejection fraction (HFmrEF); Three-Dimensional echocardiography

Outcome Measures

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%)

  At baseline

Secondary Outcomes (2)

• 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)

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (5)

ICS Maugeri - Istituto di Bari

Bari, BA, 70124, Italy

RECRUITING

ICS Maugeri - Istituto di Milano

Milan, MI, 20138, Italy

RECRUITING

ICS Maugeri - Istituto di Pavia

Pavia, PV, 27100, Italy

RECRUITING

ICS Maugeri Torino

Torino, TO, 10124, Italy

RECRUITING

ICS Maugeri - Istituto di Veruno

Veruno, 28013, Italy

RECRUITING

Related Publications (6)

• Saito K, Okura H, Watanabe N, Hayashida A, Obase K, Imai K, Maehama T, Kawamoto T, Neishi Y, Yoshida K. Comprehensive evaluation of left ventricular strain using speckle tracking echocardiography in normal adults: comparison of three-dimensional and two-dimensional approaches. J Am Soc Echocardiogr. 2009 Sep;22(9):1025-30. doi: 10.1016/j.echo.2009.05.021. Epub 2009 Jun 24.

  PMID: 19556106 BACKGROUND

• Muraru D, Cucchini U, Mihaila S, Miglioranza MH, Aruta P, Cavalli G, Cecchetto A, Padayattil-Jose S, Peluso D, Iliceto S, Badano LP. Left ventricular myocardial strain by three-dimensional speckle-tracking echocardiography in healthy subjects: reference values and analysis of their physiologic and technical determinants. J Am Soc Echocardiogr. 2014 Aug;27(8):858-871.e1. doi: 10.1016/j.echo.2014.05.010. Epub 2014 Jun 26.

  PMID: 24975996 BACKGROUND

• Kalam K, Otahal P, Marwick TH. Prognostic implications of global LV dysfunction: a systematic review and meta-analysis of global longitudinal strain and ejection fraction. Heart. 2014 Nov;100(21):1673-80. doi: 10.1136/heartjnl-2014-305538. Epub 2014 May 23.

  PMID: 24860005 BACKGROUND

• Hjertaas JJ, Fossa H, Dybdahl GL, Gruner R, Lunde P, Matre K. Accuracy of real-time single- and multi-beat 3-d speckle tracking echocardiography in vitro. Ultrasound Med Biol. 2013 Jun;39(6):1006-14. doi: 10.1016/j.ultrasmedbio.2013.01.010. Epub 2013 Apr 3.

  PMID: 23562013 BACKGROUND

• Geyer H, Caracciolo G, Abe H, Wilansky S, Carerj S, Gentile F, Nesser HJ, Khandheria B, Narula J, Sengupta PP. Assessment of myocardial mechanics using speckle tracking echocardiography: fundamentals and clinical applications. J Am Soc Echocardiogr. 2010 Apr;23(4):351-69; quiz 453-5. doi: 10.1016/j.echo.2010.02.015.

  PMID: 20362924 BACKGROUND

• Aly D, Madan N, Kuzava L, Samrany A, Parthiban A. Comprehensive evaluation of left ventricular deformation using speckle tracking echocardiography in normal children: comparison of three-dimensional and two-dimensional approaches. Cardiovasc Ultrasound. 2022 Jan 27;20(1):3. doi: 10.1186/s12947-022-00273-6.

  PMID: 35086543 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Oronzo Catalano, MD

CONTACT

+39(0)382592608; oronzo.catalano@icsmaugeri.it

Miriam De Giorgi, DMS

CONTACT

+39(0)382592982; miriam.degiorgi@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Start date: 6 months after publication of the primary study results. End date: 5 years after publication of the primary study results.
• Access Criteria: De-identified individual participant data underlying the published results, together with the study protocol and statistical analysis plan, will be available to qualified researchers upon reasonable request to the principal investigator. Access will be granted following review and approval of a research proposal and completion of a data-sharing agreement. Data will be provided electronically in a secure manner

Locations

IT (5)