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

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.

NCT Number	NCT07150455
Lead Sponsor	Ankara Training and Research Hospital
Conditions	Fibromyalgia (FM), Subclinical Ventricular Dysfunction, Myocardial Function
Enrollment	118 participants
Start Date	2025-08-01
Primary Completion	2026-03-15 (estimated)
Study Completion	2026-03-20 (estimated)
Updated on ClinicalTrials.gov	2026-03-25