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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Tamer Tamdogan, MD
- Telefonnummer: 0905065449917
- E-mail: tamer.tamdogan@giresun.edu.tr
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Serum NLRP3 Concentration
Tidsramme: Baseline and 30 ± 7 days after treatment initiation
|
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.
|
Baseline and 30 ± 7 days after treatment initiation
|
|
Change From Baseline in Serum NF-κB p65 Concentration
Tidsramme: Baseline and 30 ± 7 days after treatment initiation
|
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.
|
Baseline and 30 ± 7 days after treatment initiation
|
|
Change From Baseline in Serum STAT3 Concentration
Tidsramme: Baseline and 30 ± 7 days after treatment initiation
|
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.
|
Baseline and 30 ± 7 days after treatment initiation
|
|
Change From Baseline in Left Ventricular Global Longitudinal Strain
Tidsramme: Baseline and 30 ± 7 days after treatment initiation
|
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.
|
Baseline and 30 ± 7 days after treatment initiation
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Neuropathic Pain Intensity
Tidsramme: Baseline and 30 ± 7 days after treatment initiation
|
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
|
Baseline and 30 ± 7 days after treatment initiation
|
|
Change From Baseline in Left Ventricular Ejection Fraction
Tidsramme: Baseline and 30 ± 7 days after baseline
|
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.
|
Baseline and 30 ± 7 days after baseline
|
|
Change From Baseline in Left Atrial Volume Index
Tidsramme: Baseline and 30 ± 7 days after baseline
|
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.
|
Baseline and 30 ± 7 days after baseline
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Neuromuskulære sygdomme
- Sygdomme i det perifere nervesystem
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Neuralgi
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Kulbrinter
- Cyclohexanes
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Syrer, acyklisk
- Carboxylsyrer
- Aminer
- Aminosyrer
- Gamma-Aminobutyric Acid
- Aminobutyrater
- Butyrater
- Syrer, carbocykliske
- Cyclohexanecarboxylsyrer
- Gabapentin
- Pregabalin
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- PREGABA-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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