Evaluation of Myocardial Function by Global Longitudinal Strain (GLS) Measurement in 2D Echocardiographic Examination of Patients With Fibromyalgia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Global Longitudinal Strain (GLS) in Fibromyalgia Patients
Study Overview
Brief 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.
Detailed Description
Fibromyalgia (FM) is a chronic, multisystem disorder affecting approximately 2-4% of the general population, predominantly women. It is characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, anxiety, cognitive impairment, and autonomic symptoms such as gastrointestinal irregularities, Raynaud-like phenomena, and sicca complaints. The pathophysiology remains incompletely understood but is thought to involve central pain sensitization and dysautonomia.
Emerging evidence indicates that FM is associated with increased cardiovascular risk. Observational studies have demonstrated a higher prevalence of endothelial dysfunction, arterial stiffness, arrhythmias, and coronary artery disease in FM patients. Mechanistically, chronic sympathetic overactivity and persistent catecholamine release may increase myocardial oxygen demand, impair microvascular perfusion, and lead to subtle myocardial dysfunction. Autonomic imbalance has also been documented by heart rate variability studies, supporting impaired sympathetic-parasympathetic regulation. Importantly, the overlap between FM symptoms (fatigue, poor sleep, reduced functional capacity) and those of heart failure suggests a potential underrecognized cardiac component in FM.
Conventional echocardiography relies on left ventricular ejection fraction (LVEF) to evaluate systolic function. However, LVEF may remain normal despite underlying myocardial impairment and is strongly affected by loading conditions and observer variability. Many patients with heart failure present with preserved ejection fraction (HFpEF), underscoring the limitations of LVEF as an early marker of myocardial dysfunction.
Global Longitudinal Strain (GLS), assessed using two-dimensional speckle-tracking echocardiography (2D-STE), has emerged as a more sensitive and reproducible tool for detecting early myocardial dysfunction. GLS abnormalities can precede measurable reductions in LVEF and have prognostic value across diverse conditions including ischemic heart disease, hypertension, valvular disease, chemotherapy-related cardiotoxicity, and heart failure.
Preliminary studies in FM populations suggest possible subclinical myocardial involvement. Some reports describe increased risk of diastolic dysfunction and impaired GLS in FM patients, possibly reflecting the impact of chronic stress and autonomic dysregulation on cardiac mechanics. Nevertheless, systematic and adequately powered investigations remain scarce.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 18 and 50 years.
- •No diagnosis of fibromyalgia.
- •Volunteers presenting with mechanical low back pain but otherwise healthy.
Exclusion Criteria
- •Hypertension.
- •Coronary artery disease.
- •Diabetes mellitus.
- •Significant valvular heart disease.
- •Documented arrhythmias.
- •Congestive heart failure.
- •Systemic rheumatic diseases (e.g., SLE, RA).
- •Hyperthyroidism or hypothyroidism.
Arms & Interventions
Fibromyalgia Patients
Participants aged 18-50 years diagnosed with fibromyalgia according to the 2010 American College of Rheumatology (ACR) criteria. All participants in this group will undergo 2D speckle-tracking echocardiography, including Global Longitudinal Strain (GLS) measurement, for evaluation of myocardial function. No drug or device intervention is administered.
Intervention: Echocardiographic Assessment (2D Speckle Tracking) (Other)
Healthy Controls
Age- and sex-matched volunteers without fibromyalgia, presenting with mechanical low back pain, otherwise healthy.
Intervention: Echocardiographic Assessment (2D Speckle Tracking) (Other)
Outcomes
Primary Outcomes
Global Longitudinal Strain (GLS) in Fibromyalgia Patients
Time Frame: At the time of echocardiographic examination (Day 1, single assessment).
Evaluation of left ventricular myocardial function by measuring Global Longitudinal Strain (GLS) using two-dimensional speckle-tracking echocardiography. GLS values of fibromyalgia patients will be compared with those of healthy controls to assess the presence of subclinical ventricular dysfunction.
Secondary Outcomes
- Correlation Between Global Longitudinal Strain (GLS) and Fibromyalgia Impact Questionnaire (FIQ) Scores(At the time of clinical and echocardiographic assessment (Day 1).)
- Prevalence of Subclinical Ventricular Dysfunction in Fibromyalgia Patients(At the time of echocardiographic examination (Day 1).)
Investigators
Nadide Koca
Physical Medicine & Rehabilitation Specialist
Ankara Training and Research Hospital