Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

Официальное название

Continuous Heart Rate Variability Monitoring for Predicting Response to Biologic Therapy in Inflammatory Bowel Disease: A Prospective Cohort Study

Обзор

This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du Hospital, and Air Force 986 Hospital. All patients will undergo HRV monitoring at baseline, Week 2, Week 6, and Week 14. The HRV monitoring results will be blinded to both physicians and patients. Based on the efficacy assessment at Week 14, patients will be divided into response and non-response groups for comparison, to analyze the strength of association between baseline HRV parameters and the achievement of clinical response. The study plans to enroll 100 IBD patients, with 50 in the IFX treatment group and 50 in the VDZ treatment group.

Первичные конечные точки

• Disease activity [Срок оценки: At baseline, Week 2, Week 6, and Week 14.]
• Heart Rate Variability [Срок оценки: At baseline, Week 2, Week 6, and Week 14.]

Вторичные конечные точки (8)

• Sleep Monitoring [Срок оценки: During 14 weeks of treatment.]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: At baseline, Week 6, and Week 14.]
• Insomnia Severity Index (ISI) [Срок оценки: At baseline, Week 6, and Week 14.]
• Flinders Fatigue Scale (FFS) [Срок оценки: At baseline, Week 6, and Week 14.]
• Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: At baseline, Week 6, and Week 14.]
• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: At baseline, Week 6, and Week 14.]
• Therapeutic drug monitoring [Срок оценки: Week 14.]
• Fecal calprotectin (FC) [Срок оценки: At baseline and Week 14.]

Критерии участия

Критерии включения

• Diagnosed with UC according to the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 · Xi'an) or diagnosed with CD according to the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023 · Guangzhou) at least 3 months before enrollment;
• Initiation of IFX or VDZ treatment for the first time based on actual clinical needs;
• Concomitant use of stable doses of 5-ASA or immunosuppressants is permitted;
• Able and willing to wear an HRV monitoring device and sign an informed consent form.

Критерии исключения

• Patients receiving combination therapy with two or more biological agents;
• History of IBD-related surgery within the past 4 weeks or planned surgery during the study period;
• Current severe intestinal infection (e.g., uncontrolled Clostridium difficile or cytomegalovirus infection);
• Diagnosed extensive small bowel resection or short bowel syndrome;
• Uncontrolled psychiatric disorders (e.g., severe anxiety or depression) or use of anti-anxiety/depressant medications that may affect autonomic nervous function;
• Use of medications affecting heart rate or autonomic nervous function without the ability to maintain a stable dose during the trial (e.g., beta-blockers, calcium channel blockers, etc.);
• Coexisting conditions related to autonomic dysfunction (e.g., hyperthyroidism, thyroiditis, hypertension, various types of conduction blocks, arrhythmias, etc.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Xijing Hospital — Сиань

Идентификаторы

NCT: NCT07475052 · KY20252534

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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