[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651091":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":32,"locations":10,"responsibleParty":38,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":55,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":10},{"fullName":5,"class":6},"Giresun University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Gabapentin Cohort",null,"Adults with peripheral neuropathic pain who are prescribed gabapentin by the treating physician as part of routine clinical care, independently of study participation. Baseline assessments will be completed before the first dose, and follow-up assessments will be performed 30 ± 7 days later. The investigators will not assign the medication, determine the dose, or modify treatment decisions.",[13],"Drug: Gabapentin",{"label":15,"type":10,"description":16,"interventionNames":17},"Pregabalin Cohort","Adults with peripheral neuropathic pain who are prescribed pregabalin by the treating physician as part of routine clinical care, independently of study participation. Baseline assessments will be completed before the first dose, and follow-up assessments will be performed 30 ± 7 days later. The investigators will not assign the medication, determine the dose, or modify treatment decisions.",[18],"Drug: Pregabalin",{"label":20,"type":10,"description":21,"interventionNames":10},"Healthy Control Cohort","Adults without peripheral neuropathy or chronic neuropathic pain and without current gabapentin or pregabalin use. Healthy controls will be frequency matched to the patient cohorts, as feasible, by age, sex, and body mass index. Assessments will be performed at enrollment and again after 30 ± 7 days. Participants in this cohort will not receive gabapentin or pregabalin as part of the study.",[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DRUG","Gabapentin","Gabapentin prescribed as part of routine clinical care for peripheral neuropathic pain. The decision to initiate treatment, as well as the starting dose, dose adjustments, continuation, or discontinuation, will be determined by the treating physician independently of study participation. The study investigators will not assign or modify treatment.",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Pregabalin","Pregabalin prescribed as part of routine clinical care for peripheral neuropathic pain. The decision to initiate treatment, as well as the starting dose, dose adjustments, continuation, or discontinuation, will be determined by the treating physician independently of study participation. The study investigators will not assign or modify treatment.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Tamer Tamdogan, MD","CONTACT","0905065449917","tamer.tamdogan@giresun.edu.tr",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Tamer Tamdogan","Asst.Prof.MD","100651091","gabapentin-and-pregabalin-effects-on-inflammation-and-cardiac-function-in-peripheral-neuropathic-pain-100651091",false,"NCT07755514","Gabapentin and Pregabalin Effects on Inflammation and Cardiac Function in Peripheral Neuropathic Pain","Translational Analysis of Changes in Inflammatory Biomarkers and Subclinical Cardiac Function Associated With Gabapentin and Pregabalin Use in Patients With Peripheral Neuropathic Pain: A Prospective Controlled Cohort Study","Inclusion Criteria:\n\n* Patient Cohorts:Age 18 years or older.A clinical diagnosis of peripheral neuropathic pain based on medical history, physical and neurological examination, and, when available, electrophysiological testing or imaging.A determination, following routine clinical evaluation, that initiation of gabapentin or pregabalin is clinically appropriate.Ability to complete baseline assessments before the first dose.Ability and willingness to provide written informed consent.Healthy Controls:Age 18 years or older.Attendance at the cardiology department for a routine health examination or check-up.No peripheral neuropathy, chronic neuropathic pain, gabapentin or pregabalin use, or clinically significant cardiovascular disease based on standard clinical screening.Eligibility, as far as possible, for frequency matching with the patient cohorts by age, sex, and body mass index.Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Known or newly identified heart failure.2. Clinically significant valvular heart disease, cardiomyopathy, significant cardiac arrhythmia, previous acute coronary syndrome, or other significant structural heart disease.3. Active or recent acute infection.4. Active autoimmune or systemic inflammatory disease.5. Active malignancy.6. Recent major surgery, severe trauma, or acute cardiovascular event.7. Current systemic corticosteroid or immunosuppressive treatment.8. Advanced renal or hepatic dysfunction.9. Uncontrolled thyroid disease.10. Pregnancy or breastfeeding.11. Any acute clinical condition likely to substantially affect baseline biomarker measurements.12. Current use of gabapentin or pregabalin at baseline.13. Inability to complete baseline measurements before the first dose of gabapentin or pregabalin.14. Any other condition that, in the investigator's judgment, would prevent safe or appropriate participation in the study",true,"ALL","18 Years",{"count":53,"type":54},75,"ESTIMATED","1 Month","OBSERVATIONAL","This prospective, controlled, observational cohort study will evaluate short-term changes in inflammatory biomarkers and subclinical cardiac function in adults with peripheral neuropathic pain who are prescribed gabapentin or pregabalin as part of routine clinical care. A total of 75 participants will be enrolled: 25 patients starting gabapentin, 25 patients starting pregabalin, and 25 healthy controls without peripheral neuropathy or chronic neuropathic pain. Treatment selection and dose adjustments will be determined by the treating physician and will not be assigned by the study investigators. Participants will be assessed at baseline and again after 30 ± 7 days. Assessments will include clinical information, pain severity, routine laboratory results, inflammatory biomarkers, and standard transthoracic echocardiography. No additional blood will be collected solely for research; leftover serum from routine testing will be used. The primary aim is to compare changes over time between the gabapentin and pregabalin groups, while the healthy control group will provide a reference for interpretation.",[59],"Peripheral Neuropathic Pain",[61,62,63,64,65,66],"gabapentin","pregabalin","Inflammatory Biomarkers","Subclinical Cardiac Dysfunction","Echocardiography","Neuropathic Pain","NOT_YET_RECRUITING","2026-08-05",{"date":70,"type":71},"2026-08-10","ACTUAL",{"date":73,"type":54},"2026-08-15",{"date":75,"type":54},"2026-10-15",{"name":5,"class":6}]