CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 118 enrolled
Drug / intervention
Echocardiographic Assessment (2D Speckle Tracking)other
Likely dose
Not stated in record
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Search/NCT07150455
NCT07150455N/ACompleted

Evaluation of Myocardial Function by Global Longitudinal Strain (GLS) Measurement in 2D Echocardiographic Examination of Patients With Fibromyalgia

Ankara Training and Research Hospital·observational·Posted Sep 2, 2025·Updated Mar 25, 2026

In Brief

An observational study evaluating Echocardiographic Assessment (2D Speckle Tracking) for Fibromyalgia (FM) and 2 related conditions. Completed, enrolled 118 participants across 1 site.

Detailed Summary

Fibromyalgia (FM) is a chronic pain syndrome that affects multiple body systems and is often associated with fatigue, sleep disturbances, anxiety, and other comorbidities. Increasing evidence suggests that FM is also linked to cardiovascular dysfunction due to autonomic imbalance, sympathetic overactivity, and endothelial dysfunction. Patients with FM may therefore be at higher risk of developing subclinical ventricular dysfunction even before overt cardiovascular disease becomes apparent. Traditional echocardiographic evaluation of left ventricular function is based on ejection fraction (LVEF). However, LVEF has important limitations. It may remain normal despite underlying myocardial impairment, is strongly influenced by loading conditions, and often fails to detect early myocardial dysfunction. Recent advances in echocardiography allow for the assessment of Global Longitudinal Strain (GLS), a sensitive and reproducible measure of myocardial deformation. GLS abnormalities can be detected earlier than changes in LVEF and are predictive of future declines in ejection fraction. This study aims to evaluate myocardial function in fibromyalgia patients using GLS obtained by two-dimensional speckle-tracking echocardiography (2D-STE). By comparing FM patients with age- and sex-matched healthy controls, the study seeks to determine whether FM patients show a higher prevalence of subclinical ventricular dysfunction. The study is designed as a prospective, observational, case-control study. A total of 118 participants will be enrolled: 59 patients diagnosed with fibromyalgia according to the 2010 American College of Rheumatology (ACR) criteria, and 59 control subjects without fibromyalgia. The control group will consist of volunteers presenting with mechanical low back pain but without systemic rheumatic disease. All participants will undergo echocardiographic examination using a standardized protocol with Vivid E95 Dimension ultrasound equipment (GE Healthcare). Global Longitudinal Strain will be measured offline using EchoPAC software, and results will be analyzed according to recommendations of the American Society of Echocardiography. In addition, fibromyalgia patients will complete the Fibromyalgia Impact Questionnaire (FIQ) to evaluate disease severity, and results will be compared with echocardiographic findings. Primary Outcome: Prevalence of subclinical left ventricular dysfunction, defined as impaired GLS, in fibromyalgia patients compared to controls. Secondary Outcome: Correlation between GLS values and fibromyalgia disease severity scores. This study is expected to provide new insights into the cardiovascular involvement of fibromyalgia. Detecting early myocardial impairment with GLS may help identify patients at risk of future cardiovascular complications and may support closer monitoring and preventive strategies in this population.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2026
First PostedSep 2, 2025
Enrollment StartAug 1, 2025
Primary CompletionMar 15, 2026
Study CompletionMar 20, 2026
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10 months ago

Interventions

Echocardiographic Assessment (2D Speckle Tracking)other

All participants will undergo standardized 2D echocardiographic examination including Global Longitudinal Strain (GLS) measurement. No drug or device intervention is applied.