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

NCT07150455 | Completed

• 1 other identifier: AnkaraTRH-FTR-NK-07
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia (FM); Subclinical Ventricular Dysfunction; Myocardial Function

Keywords

Fibromyalgia; Global Longitudinal Strain (GLS); 2D Echocardiography; Speckle Tracking Echocardiography; Fibromyalgia Impact Questionnaire (FIQ); Autonomic Dysfunction; Left Ventricular Function

Outcome Measures

Primary Outcomes (1)

• Global Longitudinal Strain (GLS) in Fibromyalgia Patients

  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.

  At the time of echocardiographic examination (Day 1, single assessment).

Secondary Outcomes (2)

• 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).

Study Arms (2)

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.

Other: Echocardiographic Assessment (2D Speckle Tracking)

Healthy Controls

Age- and sex-matched volunteers without fibromyalgia, presenting with mechanical low back pain, otherwise healthy.

Other: Echocardiographic Assessment (2D Speckle Tracking)

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.

Fibromyalgia Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-50 years diagnosed with fibromyalgia according to the 2010 ACR criteria recruited from the Physical Medicine and Rehabilitation outpatient clinic of Ankara Training and Research Hospital, and age- and sex-matched healthy controls presenting with mechanical low back pain but without systemic disease.

You may qualify if:

• Age between 18 and 50 years.
• No diagnosis of fibromyalgia.
• Volunteers presenting with mechanical low back pain but otherwise healthy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (17)

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  PMID: 31711726 BACKGROUND

• Galvez-Sanchez CM, Reyes Del Paso GA. Diagnostic Criteria for Fibromyalgia: Critical Review and Future Perspectives. J Clin Med. 2020 Apr 23;9(4):1219. doi: 10.3390/jcm9041219.

  PMID: 32340369 BACKGROUND

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  PMID: 32472988 BACKGROUND

• Tschope C, Senni M. Usefulness and clinical relevance of left ventricular global longitudinal systolic strain in patients with heart failure with preserved ejection fraction. Heart Fail Rev. 2020 Jan;25(1):67-73. doi: 10.1007/s10741-019-09853-7.

  PMID: 31489515 BACKGROUND

• Ueyama H, Kuno T, Takagi H, Krishnamoorthy P, Prandi FR, Palazzuoli A, Sharma SK, Kini A, Lerakis S. Prognostic value of left ventricular global longitudinal strain in mitral regurgitation: a systematic review. Heart Fail Rev. 2023 Mar;28(2):465-483. doi: 10.1007/s10741-022-10265-3. Epub 2022 Jul 28.

  PMID: 35900680 BACKGROUND

• Smiseth OA, Rider O, Cvijic M, Valkovic L, Remme EW, Voigt JU. Myocardial Strain Imaging: Theory, Current Practice, and the Future. JACC Cardiovasc Imaging. 2025 Mar;18(3):340-381. doi: 10.1016/j.jcmg.2024.07.011. Epub 2024 Sep 11.

  PMID: 39269417 BACKGROUND

• Velagapudi VM, Pidikiti R, Tighe DA. Is Left Ventricular Global Longitudinal Strain by Two-Dimensional Speckle Tracking Echocardiography in Sepsis Cardiomyopathy Ready for Prime Time Use in the ICU? Healthcare (Basel). 2019 Jan 3;7(1):5. doi: 10.3390/healthcare7010005.

  PMID: 30609787 BACKGROUND

• Potter E, Marwick TH. Assessment of Left Ventricular Function by Echocardiography: The Case for Routinely Adding Global Longitudinal Strain to Ejection Fraction. JACC Cardiovasc Imaging. 2018 Feb;11(2 Pt 1):260-274. doi: 10.1016/j.jcmg.2017.11.017.

  PMID: 29413646 BACKGROUND

• Cho KI, Lee JH, Lee HG, Kim SM, Kim TI. Assessment of myocardial function in patients with fibromyalgia and the relationship to chronic emotional and physical stress. Korean Circ J. 2010 Feb;40(2):74-80. doi: 10.4070/kcj.2010.40.2.74. Epub 2010 Feb 23.

  PMID: 20182592 BACKGROUND

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  PMID: 30207569 BACKGROUND

• Gist AC, Guymer EK, Ajani AE, Littlejohn GO. Fibromyalgia has a high prevalence and impact in cardiac failure patients. Eur J Rheumatol. 2017 Dec;4(4):245-249. doi: 10.5152/eurjrheum.2017.17026. Epub 2017 Nov 2.

  PMID: 29308277 BACKGROUND

• Zetterman T, Markkula R, Miettinen T, Kalso E. Heart rate variability responses to cognitive stress in fibromyalgia are characterised by inadequate autonomous system stress responses: a clinical trial. Sci Rep. 2023 Jan 13;13(1):700. doi: 10.1038/s41598-023-27581-9.

  PMID: 36639565 BACKGROUND

• Su CH, Chen JH, Lan JL, Wang YC, Tseng CH, Hsu CY, Huang L. Increased Risk of Coronary Heart Disease in Patients with Primary Fibromyalgia and Those with Concomitant Comorbidity-A Taiwanese Population-Based Cohort Study. PLoS One. 2015 Sep 14;10(9):e0137137. doi: 10.1371/journal.pone.0137137. eCollection 2015.

  PMID: 26366998 BACKGROUND

• Tsai PS, Fan YC, Huang CJ. Fibromyalgia is associated with coronary heart disease: a population-based cohort study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):37-42. doi: 10.1097/AAP.0000000000000190.

  PMID: 25436616 BACKGROUND

• Sethi P, Peiris CD. A Review of Catecholamine Associated Cardiomyopathies and Channelopathies. Cureus. 2020 Feb 11;12(2):e6957. doi: 10.7759/cureus.6957.

  PMID: 32195067 BACKGROUND

• Kocyigit BF, Akyol A. Coexistence of fibromyalgia syndrome and inflammatory rheumatic diseases, and autonomic cardiovascular system involvement in fibromyalgia syndrome. Clin Rheumatol. 2023 Mar;42(3):645-652. doi: 10.1007/s10067-022-06385-8. Epub 2022 Sep 23.

  PMID: 36151442 BACKGROUND

• Kulshreshtha P, Deepak KK, Yadav RK, Mukherjee D. Cardiac autonomic neuropathy in fibromyalgia: Revisited. J Back Musculoskelet Rehabil. 2022;35(1):111-117. doi: 10.3233/BMR-200209.

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MeSH Terms

Conditions

Fibromyalgia; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine & Rehabilitation Specialist

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: August 1, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 20, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)