Fibromyalgia (FM)GLS in FMNCT07150455
Evaluation of Myocardial Function by Global Longitudinal Strain (GLS) Measurement in 2D Echocardiography of Patients With Fibromyalgia
An observational study of Fibromyalgia (FM) and Subclinical Ventricular Dysfunction, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia (FM), Subclinical Ventricular Dysfunction, Myocardial Function
- What is being tested?
- Echocardiographic Assessment (2D Speckle Tracking)
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 20 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Age between 18 and 50 years.
- No diagnosis of fibromyalgia.
- Volunteers presenting with mechanical low back pain but otherwise healthy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
Official title: Evaluation of Myocardial Function by Global Longitudinal Strain (GLS) Measurement in 2D Echocardiographic Examination 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.
Read more
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.
Read the 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.
This prospective, observational, case-control study is designed to fill this knowledge gap. The study will enroll 59 FM patients diagnosed according to the 2010 American College of Rheumatology (ACR) criteria and 59 age- and sex-matched controls without systemic rheumatic disease. Echocardiographic examinations will be performed using a standardized protocol (Vivid E95, GE Healthcare), and GLS will be measured offline with EchoPAC software, following the American Society of Echocardiography guidelines. Disease severity in FM will be assessed using the Fibromyalgia Impact Questionnaire (FIQ).
The primary hypothesis is that FM patients will demonstrate a higher prevalence of impaired GLS, consistent with subclinical ventricular dysfunction, compared with controls. The secondary hypothesis is that higher FIQ scores will correlate with greater impairment in GLS, suggesting a relationship between disease burden and cardiac involvement.
The anticipated significance of this research lies in clarifying the cardiovascular component of fibromyalgia. Early identification of myocardial dysfunction using GLS may allow for improved risk stratification, closer clinical monitoring, and preventive strategies aimed at reducing long-term cardiovascular morbidity. Beyond its clinical relevance, this study also extends the application of GLS into a non-traditional, rheumatology-related context, reinforcing the systemic nature of FM and the need for interdisciplinary management approaches.
- Being tested
- Echocardiographic Assessment (2D Speckle Tracking)
- Keywords
- Fibromyalgia, Global Longitudinal Strain (GLS), 2D Echocardiography, Speckle Tracking Echocardiography, Fibromyalgia Impact Questionnaire (FIQ), Autonomic Dysfunction, Left Ventricular Function
- Medical subject headings
- Fibromyalgia, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Echocardiographic Assessment (2D Speckle Tracking) | |
| Healthy Controls | Age- and sex-matched volunteers without fibromyalgia, presenting with mechanical low back pain, otherwise healthy. Receives: Other: Echocardiographic Assessment (2D Speckle Tracking) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The relationship between GLS values and disease severity will be evaluated by correlating echocardiographic GLS with the Fibromyalgia Impact Questionnaire (FIQ). The FIQ ranges from 0 to 100, with higher scores indicating worse disease impact. It is hypothesized that higher FIQ scores will correlate with impaired GLS values (less negative strain).
Measured: At the time of clinical and echocardiographic assessment (Day 1).
Prevalence of Subclinical Ventricular Dysfunction in Fibromyalgia Patients
The proportion of fibromyalgia patients with impaired GLS (< -18%) compared to healthy controls will be calculated to estimate the prevalence of subclinical ventricular dysfunction in the study population.
Measured: At the time of echocardiographic examination (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Aug 2025
- Primary completion15 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadide Koca, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150455
- Sponsor's protocol ID
- AnkaraTRH-FTR-NK-07
- Acronym
- GLS in FM
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies regarding patient privacy and data protection regulations
Publications
Chang KV, Hung CH, Sun WZ, Wu WT, Lai CL, Han DS, Chen CC. Evaluating soreness symptoms of fibromyalgia: Establishment and validation of the Revised Fibromyalgia Impact Questionnaire with Integration of Soreness Assessment. J Formos Med Assoc. 2020 Jul;119(7):1211-1218. doi: 10.1016/j.jfma.2019.10.018. Epub 2019 Nov 9.
PubMed 31711726Galvez-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.
PubMed 32340369Rong LQ, Neuburger PJ, Kim J, Devereux RB. Left ventricular global longitudinal strain and cardiac surgical outcomes. Minerva Cardioangiol. 2020 Oct;68(5):489-496. doi: 10.23736/S0026-4725.20.05251-2. Epub 2020 May 29.
PubMed 32472988Tschope 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.
PubMed 31489515Ueyama 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.
PubMed 35900680Smiseth 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.
PubMed 39269417Velagapudi 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.
PubMed 30609787Potter 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.
PubMed 29413646Cho 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.
PubMed 20182592Sayilir S, Ergun G, Ekiz T. Evaluation of Ventricular Diastolic Function in Patients With Fibromyalgia Syndrome. Arch Rheumatol. 2017 Aug 15;33(2):150-153. doi: 10.5606/ArchRheumatol.2018.6541. eCollection 2018 Jun.
PubMed 30207569Gist 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.
PubMed 29308277Zetterman 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.
PubMed 36639565Su 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.
PubMed 26366998Tsai 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.
PubMed 25436616Sethi P, Peiris CD. A Review of Catecholamine Associated Cardiomyopathies and Channelopathies. Cureus. 2020 Feb 11;12(2):e6957. doi: 10.7759/cureus.6957.
PubMed 32195067
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Myocardial Function by Global Longitudinal Strain (GLS) Measurement in 2D Echocardiographic Examination of Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07150455
- Acronym / sponsor ID
- GLS in FM / AnkaraTRH-FTR-NK-07
- Keywords
- Fibromyalgia, Global Longitudinal Strain (GLS), 2D Echocardiography, Speckle Tracking Echocardiography, Fibromyalgia Impact Questionnaire (FIQ), Autonomic Dysfunction, Left Ventricular Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
This prospective, observational, case-control study is designed to fill this knowledge gap. The study will enroll 59 FM patients diagnosed according to the 2010 American College of Rheumatology (ACR) criteria and 59 age- and sex-matched controls without systemic rheumatic disease. Echocardiographic examinations will be performed using a standardized protocol (Vivid E95, GE Healthcare), and GLS will be measured offline with EchoPAC software, following the American Society of Echocardiography guidelines. Disease severity in FM will be assessed using the Fibromyalgia Impact Questionnaire (FIQ).
The primary hypothesis is that FM patients will demonstrate a higher prevalence of impaired GLS, consistent with subclinical ventricular dysfunction, compared with controls. The secondary hypothesis is that higher FIQ scores will correlate with greater impairment in GLS, suggesting a relationship between disease burden and cardiac involvement.
The anticipated significance of this research lies in clarifying the cardiovascular component of fibromyalgia. Early identification of myocardial dysfunction using GLS may allow for improved risk stratification, closer clinical monitoring, and preventive strategies aimed at reducing long-term cardiovascular morbidity. Beyond its clinical relevance, this study also extends the application of GLS into a non-traditional, rheumatology-related context, reinforcing the systemic nature of FM and the need for interdisciplinary management approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Patients | – | Other: Echocardiographic Assessment (2D Speckle Tracking)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. |
| Healthy Controls | – | Other: Echocardiographic Assessment (2D Speckle Tracking)Age- and sex-matched volunteers without fibromyalgia, presenting with mechanical low back pain, otherwise healthy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Age between 18 and 50 years.
- No diagnosis of fibromyalgia.
- Volunteers presenting with mechanical low back pain but otherwise healthy.
Key exclusion criteria (8 listed)
- Hypertension.
- Coronary artery disease.
- Diabetes mellitus.
- Significant valvular heart disease.
- Documented arrhythmias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiographic Assessment (2D Speckle Tracking)All participants will undergo standardized 2D echocardiographic examination including Global Longitudinal Strain (GLS) measurement. No drug or device intervention is applied. | Other | Fibromyalgia Patients, Healthy Controls |
Primary outcome
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.
2 secondary outcomes
Correlation Between Global Longitudinal Strain (GLS) and Fibromyalgia Impact Questionnaire (FIQ) Scores
Time frame: At the time of clinical and echocardiographic assessment (Day 1).
Prevalence of Subclinical Ventricular Dysfunction in Fibromyalgia Patients
Time frame: At the time of echocardiographic examination (Day 1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 31711726Chang KV, Hung CH, Sun WZ, Wu WT, Lai CL, Han DS, Chen CC. Evaluating soreness symptoms of fibromyalgia: Establishment and validation of the Revised Fibromyalgia Impact Questionnaire with Integration of Soreness Assessment. J Formos Med Assoc. 2020 Jul;119(7):1211-1218. doi: 10.1016/j.jfma.2019.10.018. Epub 2019 Nov 9.
- Background: PubMed 32340369Galvez-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.
- Background: PubMed 32472988Rong LQ, Neuburger PJ, Kim J, Devereux RB. Left ventricular global longitudinal strain and cardiac surgical outcomes. Minerva Cardioangiol. 2020 Oct;68(5):489-496. doi: 10.23736/S0026-4725.20.05251-2. Epub 2020 May 29.
- Background: PubMed 31489515Tschope 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.
- Background: PubMed 35900680Ueyama 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.
- Background: PubMed 39269417Smiseth 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.
- Background: PubMed 30609787Velagapudi 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.
- Background: PubMed 29413646Potter 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.
- Background: PubMed 20182592Cho 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.
- Background: PubMed 30207569Sayilir S, Ergun G, Ekiz T. Evaluation of Ventricular Diastolic Function in Patients With Fibromyalgia Syndrome. Arch Rheumatol. 2017 Aug 15;33(2):150-153. doi: 10.5606/ArchRheumatol.2018.6541. eCollection 2018 Jun.
- Background: PubMed 29308277Gist 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.
- Background: PubMed 36639565Zetterman 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies regarding patient privacy and data protection regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia (FM) and Subclinical Ventricular Dysfunction, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Longitudinal Strain (GLS) in Fibromyalgia Patients (time frame: At the time of echocardiographic examination (Day 1, single assessment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07150455, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.