Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Inhaled Hydrogen Therapy's Effect on Early Recurrences of Atrial Fibrillation Post-ablation. (H2-FA)

3. november 2026 opdateret af: University Hospital, Grenoble

Inhaled Hydrogen Therapy's Effect on Early Recurrences of Atrial Fibrillation Post-ablation. Phase II, Multicenter, Randomized, Controlled, Open-label Clinical Trial

The goal of this clinical trial is to testing the perioperative inhaled hydrogen (H2) administration's effects during atrial fibrillation ablations (AF) to reduce both early and late recurrences associated with this procedure.

Researchers will compare H2 inhalation to the standard of care to see if we observe a reduction in AF recurrence after ablation but also a reduction in rehospitalizations or emergency visits for cardioversion, and consequently an improvement in quality of life.

Participants will:

  • have an AF ablation associated to an hydrogen therapy or standard of care
  • complete quality of life questionnaires
  • record ECG on KardiaMobile©
  • Keep a diary of their symptoms
  • have a blood test
  • have 2 follow-up visits (after 3 and 12 months) and 2 phone calls (after 6 and 9 months)

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

124

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
    • Isère
      • Grenoble, Isère, Frankrig, 38000
        • Chu Grenoble Alpes
        • Ledende efterforsker:
          • Pascal DEFAYE, Pr
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Sandrine VENIER, Dr
        • Underforsker:
          • Peggy JACON, Dr
        • Underforsker:
          • Adrien CARABELLI, Dr
    • Rhone
      • Bron, Rhone, Frankrig, 69500
        • Hopital Louis Pradel
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Philippe CHEVALIER, Pr
        • Underforsker:
          • Kevin GARDEY, Dr

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Be over 18 years old
  2. Present with paroxysmal or persistent Atrial Fibrilation (AF) of less than 6 months with symptoms
  3. Be a candidate for a first-time AF ablation (cryoablation and electroporation)
  4. Understand and agree to comply with the study procedures
  5. Patient must have a smartphone
  6. Be enrolled in a social security scheme, or have equivalent rights
  7. Have signed the study consent form

Exclusion Criteria:

  1. Being over 80 years old
  2. Having a left atrial diameter ≥ 50mm on transthoracic echocardiography
  3. Radiofrequency ablation
  4. Having a history of AF ablation
  5. Patient on long-term anti-inflammatory treatment
  6. Patient with gas administration equipment (CPAP, NIV…)
  7. Woman of childbearing potential*
  8. Non-cooperative patient
  9. In the exclusion period for another study
  10. Persons covered by Articles L1121-5 to L1121-8 of the Public Health Code and Articles 31 to 35 of Regulation 536/2014 (corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a healthcare or social facility for purposes other than research, minors, persons subject to legal protection measures or unable to give their consent).
  11. Staff with a hierarchical relationship with the principal investigator

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standard of care

patients treated with usual care (Standard of Care)
Eksperimentel: H2

patient treated with inhaled hydrogen therapy during the perioperative period
Medicin: Hydrogen Gas (H2)

Patients treated with inhaled hydrogen therapy in the perioperative period (initiation of inhaled hydrogen therapy from hospital admission until discharge, except in the operating room) (dosage : H2/N2 3.6%/96.4%, 1 L/min 24 hours a day)

Andre navne:
  • inhaled hydrogen therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effectiveness of inhaled hydrogen therapy on early recurrences of atrial fibrillation post-ablation and on the improvement of quality of life at 3 months
Tidsramme: From baseline (before ablation) to 3 months after ablation

Composite binary endpoint, reported as the number of participants meeting both criteria: (1) no early recurrence during the blanking period (first 3 months after ablation), where recurrence is defined as any episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting at least 30 seconds; AND (2) improvement in quality of life, defined as an improvement in quality of life, defined as an increase of at least 5 points in the AFEQT overall score (range 0-100; higher scores indicate better quality of life) between baseline and 3 months.
From baseline (before ablation) to 3 months after ablation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of hospitalizations or electrical cardioversions or pharmacological cardioversions during the blanking period (3 months)
Tidsramme: From ablation to 3 months after ablation

Total number of hospitalizations or electrical cardioversions or pharmacological cardioversions occurring during the blanking period, i.e. the first 3 months after ablation. The three event types are summed into a single count per participant.
From ablation to 3 months after ablation
Incidence of Late Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence Between 3 and 12 Months After Ablation
Tidsramme: From 3 months to 12 months after ablation

Number of participants with late recurrence, defined as any episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting at least 30 seconds on Holter or Kardia recording, or recorded on a 12-lead electrocardiogram, occurring more than 3 months and up to 12 months after ablation.
From 3 months to 12 months after ablation
Change in White Blood Cell Count (WBC) from before ablation to 24 and 48 hours after ablation
Tidsramme: 24 hours before ablation, 24 hours after ablation, and 48 hours after ablation

Change in blood white blood cell (WBC) count, measured in 10^9 cells/L, between 24 hours before ablation and 24 hours and 48 hours after ablation.
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
Change in High-Sensitivity C-Reactive Protein (CRP) from before ablation to 24 and 48 hours after Ablation
Tidsramme: 24 hours before ablation, 24 hours after ablation, and 48 hours after ablation

Change in blood high-sensitivity C-reactive protein (hs-CRP) concentration, measured in mg/L, between 24 hours before ablation and 24 hours and 48 hours after ablation.
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
Change in Interleukin-6 from before ablation to 24 and 48 hours after Ablation
Tidsramme: 24 hours before ablation, 24 hours after ablation, and 48 hours after ablation

Change in blood interleukin-6 (IL-6) concentration, measured in pg/mL, between 24 hours before ablation and 24 hours and 48 hours after ablation.
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
Incidence of Adverse Events Graded by NCI-CTCAE Version 5.0 (Safety and Tolerability)
Tidsramme: From the start of inhaled hydrogen therapy to 12 months after ablation

Number of participants with adverse events, described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grades range from 1 (mild) to 5 (death related to adverse event); higher grades indicate more severe events.
From the start of inhaled hydrogen therapy to 12 months after ablation
Evaluate the acceptability of hydrogen therapy treatment by healthcare providers
Tidsramme: Day 2 after ablation

Custom hetero-questionnaire on the acceptability of hydrogen therapy treatment by healthcare providers
Day 2 after ablation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Grenoble

Samarbejdspartnere

University Grenoble Alps

Efterforskere

  • Ledende efterforsker: Pascal DEFAYE, Pr, CHU Grenoble Alpes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. september 2029

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 38RC22.0404
  • 2024-520131-33-00 (Ctis)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner