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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Tamer Tamdogan, MD
- Numero di telefono: 0905065449917
- Email: tamer.tamdogan@giresun.edu.tr
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Gabapentin Cohort
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.
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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.
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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.
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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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Serum NLRP3 Concentration
Lasso di tempo: Baseline and 30 ± 7 days after treatment initiation
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Serum NLRP3 concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing.
Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit.
Change will be calculated as the follow-up value minus the baseline value.
The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
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Baseline and 30 ± 7 days after treatment initiation
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Change From Baseline in Serum NF-κB p65 Concentration
Lasso di tempo: Baseline and 30 ± 7 days after treatment initiation
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Serum nuclear factor kappa B p65 (NF-κB p65) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing.
Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit.
Change will be calculated as the follow-up value minus the baseline value.
The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
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Baseline and 30 ± 7 days after treatment initiation
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Change From Baseline in Serum STAT3 Concentration
Lasso di tempo: Baseline and 30 ± 7 days after treatment initiation
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Serum signal transducer and activator of transcription 3 (STAT3) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing.
Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit.
Change will be calculated as the follow-up value minus the baseline value.
The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
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Baseline and 30 ± 7 days after treatment initiation
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Change From Baseline in Left Ventricular Global Longitudinal Strain
Lasso di tempo: Baseline and 30 ± 7 days after treatment initiation
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Left ventricular global longitudinal strain (LV-GLS) will be assessed by standard transthoracic echocardiography and reported as a percentage.
Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit, using the same echocardiography system and analysis software whenever possible.
Change will be calculated as the follow-up value minus the baseline value.
The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
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Baseline and 30 ± 7 days after treatment initiation
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Neuropathic Pain Intensity
Lasso di tempo: Baseline and 30 ± 7 days after treatment initiation
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Neuropathic pain intensity will be assessed in the gabapentin and pregabalin cohorts using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Change will be calculated as the follow-up score minus the baseline score
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Baseline and 30 ± 7 days after treatment initiation
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Change From Baseline in Left Ventricular Ejection Fraction
Lasso di tempo: Baseline and 30 ± 7 days after baseline
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Left ventricular ejection fraction will be measured by standard transthoracic echocardiography using the biplane Simpson method and reported as a percentage.
Change will be calculated as the follow-up value minus the baseline value.
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Baseline and 30 ± 7 days after baseline
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Change From Baseline in Left Atrial Volume Index
Lasso di tempo: Baseline and 30 ± 7 days after baseline
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Tricuspid annular plane systolic excursion (TAPSE) will be measured by transthoracic echocardiography and reported in millimeters as an indicator of right ventricular systolic function.
Change will be calculated as the follow-up value minus the baseline value.
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Baseline and 30 ± 7 days after baseline
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Collaboratori e investigatori
Sponsor
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.
- Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
- Fiore NT, Debs SR, Hayes JP, Duffy SS, Moalem-Taylor G. Pain-resolving immune mechanisms in neuropathic pain. Nat Rev Neurol. 2023 Apr;19(4):199-220. doi: 10.1038/s41582-023-00777-3. Epub 2023 Mar 1.
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Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Malattie neuromuscolari
- Malattie del sistema nervoso periferico
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Nevralgia
- Aminoacidi, peptidi e proteine
- Prodotti chimici organici
- Idrocarburi
- Ciclohexanes
- Cicloparaffins
- Idrocarburi, aliciclici
- Idrocarburi, ciclici
- Acidi, aciclici
- Acidi carbossilici
- Ammine
- Aminoacidi
- acido gamma-aminobutirrico
- Aminobutyrites
- Butirati
- Acidi, carbociclico
- Acidi cicloesanecarbossilici
- Gabapentin
- Pregabalin
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- PREGABA-2026
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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